Class I FDA device recall · Z-1879-2024
Class I — the FDA judged there is a reasonable probability that use of the product would cause serious harm or death.
This is the FDA's risk judgment for this recall. It describes the potential of the product as a category — it does not establish that any specific unit harmed anyone.
Arrow UltraFlex Intra-Aortic Balloon Catheter Kit, a) REF IAB-06830-U; b) REF IAB-06840-U; c) REF IAB-06850-U
Why it was recalled
Teleflex received reports indicating an infrequent condition that, when not identified and corrected promptly, could result in serious health consequences. The issue may manifest as: -failure of the intra-aortic balloon to completely inflate over its full length -damaged or broken central lumen in the segment contained within the balloon -helium loss or blood in the helium pathway.
Is your unit affected?
The recall covers only the specific lots or serial numbers the FDA listed. Enter the lot or serial number from your product's label and we'll check it against that list.
A match means your unit may be covered — stop and call your pharmacist before doing anything. No match suggests it isn't covered, but confirm anyway: code formats vary and lists can be incomplete. Your unit not being listed does not guarantee it is safe, and being listed does not mean you have been harmed.
Show the FDA's listed lot / code information
a) REF IAB-06830-U, UDI: (01)10801902161939(17)240731(10)18F22H0008, (01)10801902161939(17)241130(10)18F22M0019, (01)10801902161939(17)241231(10)18F23A0027, (01)10801902161939(17)241231(10)18F23A0039, (01)10801902161939(17)250131(10)18F23B0006, (01)10801902161939(17)250131(10)18F23B0020, (01)10801902161939(17)250131(10)18F23B0032, (01)10801902161939(17)250630(10)18F23G0066, (01)10801902161939(17)250731(10)18F23H0059, (01)10801902161939(17)250731(10)18F23H0070, (01)10801902161939(17)250731(10)18F23H0074, (01)10801902161939(17)250831(10)18F23J0046, (01)10801902161939(17)250930(10)18F23K0059, (01)10801902161939(17)251231(10)18F24A0036, (01)10801902161939(17)260331(10)18F24D0004, (01)10801902172898(17)240430(10)18F22E0062, (01)10801902172898(17)240531(10)18F22F0007, (01)10801902172898(17)240531(10)18F22F0017, (01)10801902172898(17)240531(10)18F22F0020, (01)10801902172898(17)240531(10)18F22F0034, (01)10801902172898(17)240531(10)18F22F0045, (01)10801902172898(17)240531(10)18F22F0057, (01)10801902172898(17)240630(10)18F22G0001, (01)10801902172898(17)240630(10)18F22G0004, (01)10801902172898(17)240630(10)18F22G0007, (01)10801902172898(17)240630(10)18F22G0014, (01)10801902172898(17)240731(10)18F22H0002, (01)10801902172898(17)240731(10)18F22H0024, (01)10801902172898(17)240731(10)18F22H0029, (01)10801902172898(17)240731(10)18F22H0034, (01)10801902172898(17)240831(10)18F22J0009, (01)10801902172898(17)250430(10)18F23D0029, (01)10801902172898(17)250430(10)18F23E0037, (01)10801902172898(17)250430(10)18F23E0038, (01)10801902172898(17)250531(10)18F23E0033, (01)10801902172898(17)250531(10)18F23E0057, (01)10801902172898(17)250531(10)18F23F0023, (01)10801902172898(17)250531(10)18F23F0045, (01)10801902172898(17)250630(10)18F23G0025, (01)10801902172898(17)250630(10)18F23G0026, (01)10801902172898(17)250630(10)18F23G0051, (01)10801902172898(17)250731(10)18F23G0067, (01)10801902172898(17)250731(10)18F23H0009, (01)10801902172898(17)250731(10)18F23H0025, (01)10801902172898(17)250731(10)18F23H0028, (01)10801902172898(17)250731(10)18F23H0069, (01)10801902172898(17)250731(10)18F23H0080, (01)10801902172898(17)250831(10)18F23H0011, (01)10801902172898(17)250831(10)18F23J0004, (01)10801902172898(17)250831(10)18F23J0011, (01)10801902172898(17)250831(10)18F23J0015, (01)10801902172898(17)250831(10)18F23J0053, (01)10801902172898(17)250831(10)18F23J0054, (01)10801902172898(17)250831(10)18F23J0055, (01)10801902172898(17)250930(10)18F23J0079, (01)10801902172898(17)250930(10)18F23K0003, (01)10801902172898(17)250930(10)18F23K0005, (01)10801902172898(17)250930(10)18F23K0009, (01)10801902172898(17)250930(10)18F23K0051, (01)10801902172898(17)250930(10)18F23K0061, (01)10801902172898(17)251031(10)18F23L0040, (01)10801902172898(17)251130(10)18F23M0002, (01)10801902172898(17)251130(10)18F23M0044, (01)10801902172898(17)251130(10)18F23M0049, (01)10801902172898(17)251130(10)18F23M0053, (01)10801902172898(17)251130(10)18F23M0054, (01)10801902172898(17)251231(10)18F23M0055, (01)10801902172898(17)251231(10)18F24A0006, (01)10801902172898(17)251231(10)18F24A0012, (01)10801902172898(17)251231(10)18F24A0013, (01)10801902172898(17)251231(10)18F24A0021, (01)10801902172898(17)260131(10)18F24B0014, (01)10801902172898(17)260228(10)18F24C0004, (01)10801902172898(17)260228(10)18F24C0005, (01)10801902172898(17)260331(10)18F24D0033, (01)10801902172898(17)260331(10)18F24D0036, (01)10801902172898(17)260331(10)18F24D0043, (01)10801902172898(17)260331(10)18F24D0048, (01)10801902172898(17)260331(10)18F24D0086; b) REF IAB-06840-U, UDI: (01)10801902161946(17)240430(10)18F22E0023, (01)10801902161946(17)240531(10)18F22F0009, (01)10801902161946(17)240531(10)18F22F0019, (01)10801902161946(17)240731(10)18F22H0014, (01)10801902161946(17)240731(10)18F22H0028, (01)10801902161946(17)240731(10)18F22H0036, (01)10801902161946(17)241130(10)18F22M0015, (01)10801902161946(17)241231(10)18F23A0019, (01)10801902161946(17)241231(10)18F23A0037, (01)10801902161946(17)241231(10)18F23A0054, (01)10801902161946(17)241231(10)18F23A0055, (01)10801902161946(17)241231(10)18F23A0061, (01)10801902161946(17)250131(10)18F23A0066, (01)10801902161946(17)250131(10)18F23A0067, (01)10801902161946(17)250228(10)18F23A0025, (01)10801902161946(17)250228(10)18F23B0018, (01)10801902161946(17)250331(10)18F23D0018, (01)10801902161946(17)250430(10)18F23E0013, (01)10801902161946(17)250430(10)18F23E0015, (01)10801902161946(17)250630(10)18F23G0002, (01)10801902161946(17)250630(10)18F23G0003, (01)10801902161946(17)250630(10)18F23G0011, (01)10801902161946(17)250731(10)18F23G0063, (01)10801902161946(17)250731(10)18F23H0034, (01)10801902161946(17)250731(10)18F23H0035, (01)10801902161946(17)250731(10)18F23H0038, (01)10801902161946(17)250731(10)18F23H0053, (01)10801902161946(17)250731(10)18F23H0058, (01)10801902161946(17)250731(10)18F23H0071, (01)10801902161946(17)250831(10)18F23J0006, (01)10801902161946(17)250831(10)18F23J0008, (01)10801902161946(17)250831(10)18F23J0014, (01)10801902161946(17)250831(10)18F23J0018, (01)10801902161946(17)250831(10)18F23J0035, (01)10801902161946(17)250831(10)18F23J0042, (01)10801902161946(17)250930(10)18F23K0028, (01)10801902161946(17)260131(10)18F24B0025, (01)10801902161946(17)260131(10)18F24B0026, (01)10801902161946(17)260228(10)18F24C0151, (01)10801902161946(17)260331(10)18F24C0171, (01)10801902161946(17)260331(10)18F24C0177, (01)10801902161946(17)260331(10)18F24C0178, (01)10801902161946(17)260331(10)18F24C0179, (01)10801902161946(17)260331(10)18F24C0180, (01)10801902161946(17)260331(10)18F24C0195, (01)10801902161946(17)260331(10)18F24D0014, (01)10801902161946(17)260331(10)18F24D0017, (01)10801902161946(17)260331(10)18F24D0030, (01)10801902172904(17)240430(10)18F22E0001, (01)10801902172904(17)240430(10)18F22E0009, (01)10801902172904(17)240430(10)18F22E0014, (01)10801902172904(17)240430(10)18F22E0020, (01)10801902172904(17)240430(10)18F22E0036, (01)10801902172904(17)240430(10)18F22E0037, (01)10801902172904(17)240430(10)18F22E0042, (01)10801902172904(17)240430(10)18F22E0046, (01)10801902172904(17)240430(10)18F22E0048, (01)10801902172904(17)240430(10)18F22E0049, (01)10801902172904(17)240430(10)18F22E0061, (01)10801902172904(17)240430(10)18F22E0065, (01)10801902172904(17)240430(10)18F22E0066, (01)10801902172904(17)240531(10)18F22F0002, (01)10801902172904(17)240531(10)18F22F0010, (01)10801902172904(17)240531(10)18F22F0016, (01)10801902172904(17)240531(10)18F22F0021, (01)10801902172904(17)240531(10)18F22F0022, (01)10801902172904(17)240531(10)18F22F0037, (01)10801902172904(17)240531(10)18F22F0043, (01)10801902172904(17)240531(10)18F22F0047, (01)10801902172904(17)240531(10)18F22F0050, (01)10801902172904(17)240531(10)18F22F0051, (01)10801902172904(17)240531(10)18F22F0054, (01)10801902172904(17)240531(10)18F22F0065, (01)10801902172904(17)240531(10)18F22F0066, (01)10801902172904(17)240531(10)18F22F0067, (01)10801902172904(17)240531(10)18F22H0026, (01)10801902172904(17)240630(10)18F22G0067, (01)10801902172904(17)240731(10)18F22H0004, (01)10801902172904(17)240731(10)18F22H0010, (01)10801902172904(17)240731(10)18F22H0030, (01)10801902172904(17)240731(10)18F22H0038, (01)10801902172904(17)240731(10)18F22H0039, (01)10801902172904(17)240930(10)18F22K0004, (01)10801902172904(17)250228(10)18F23C0017, (01)10801902172904(17)250228(10)18F23C0027, (01)10801902172904(17)250228(10)18F23C0044, (01)10801902172904(17)250331(10)18F23D0015, (01)10801902172904(17)250331(10)18R23G0002, (01)10801902172904(17)250430(10)18F23D0027, (01)10801902172904(17)250430(10)18F23D0028, (01)10801902172904(17)250430(10)18F23E0014, (01)10801902172904(17)250430(10)18F23E0028, (01)10801902172904(17)250430(10)18F23E0035, (01)10801902172904(17)250430(10)18F23E0036, (01)10801902172904(17)250430(10)18F23E0050, (01)10801902172904(17)250430(10)18F23E0051, (01)10801902172904(17)250430(10)18F23E0052, (01)10801902172904(17)250531(10)18F23E0055, (01)10801902172904(17)250531(10)18F23F0003, (01)10801902172904(17)250531(10)18F23F0006, (01)10801902172904(17)250531(10)18F23F0007, (01)10801902172904(17)250531(10)18F23F0014, (01)10801902172904(17)250531(10)18F23F0015, (01)10801902172904(17)250531(10)18F23F0024, (01)10801902172904(17)250531(10)18F23F0025, (01)10801902172904(17)250531(10)18F23F0048, (01)10801902172904(17)250531(10)18F23F0052, (01)10801902172904(17)250531(10)18F23F0054, (01)10801902172904(17)250531(10)18F23F0059, (01)10801902172904(17)250630(10)18F23G0005, (01)10801902172904(17)250630(10)18F23G0007, (01)10801902172904(17)250630(10)18F23G0014, (01)10801902172904(17)250630(10)18F23G0028, (01)10801902172904(17)250630(10)18F23G0050, (01)10801902172904(17)250630(10)18F23G0053, (01)10801902172904(17)250731(10)18F23G0064, (01)10801902172904(17)250731(10)18F23G0065, (01)10801902172904(17)250731(10)18F23H0057, (01)10801902172904(17)250731(10)18F23H0075, (01)10801902172904(17)250831(10)18F23H0033, (01)10801902172904(17)250831(10)18F23J0019, (01)10801902172904(17)250831(10)18F23J0041, (01)10801902172904(17)250831(10)18F23J0050, (01)10801902172904(17)250930(10)18F23K0017, (01)10801902172904(17)250930(10)18F23K0018, (01)10801902172904(17)250930(10)18F23K0019, (01)10801902172904(17)250930(10)18F23K0027, (01)10801902172904(17)250930(10)18F23K0040, (01)10801902172904(17)250930(10)18F23K0045, (01)10801902172904(17)250930(10)18F23K0057, (01)10801902172904(17)251031(10)18F23K0060, (01)10801902172904(17)251031(10)18F23L0006, (01)10801902172904(17)251031(10)18F23L0029, (01)10801902172904(17)251031(10)18F23L0030, (01)10801902172904(17)251130(10)18F23M0019, (01)10801902172904(17)251130(10)18F23M0020, (01)10801902172904(17)251130(10)18F23M0037, (01)10801902172904(17)251130(10)18F23M0039, (01)10801902172904(17)251130(10)18F23M0040, (01)10801902172904(17)251130(10)18F23M0041, (01)10801902172904(17)251231(10)18F23M0064, (01)10801902172904(17)251231(10)18F23M0065, (01)10801902172904(17)251231(10)18F24A0002, (01)10801902172904(17)251231(10)18F24A0003, (01)10801902172904(17)251231(10)18F24A0004, (01)10801902172904(17)251231(10)18F24A0005, (01)10801902172904(17)251231(10)18F24A0014, (01)10801902172904(17)251231(10)18F24A0016, (01)10801902172904(17)251231(10)18F24A0022, (01)10801902172904(17)251231(10)18F24A0023, (01)10801902172904(17)251231(10)18F24A0024, (01)10801902172904(17)251231(10)18F24A0038, (01)10801902172904(17)260131(10)18F24B0006, (01)10801902172904(17)260131(10)18F24B0007, (01)10801902172904(17)260131(10)18F24B0023, (01)10801902172904(17)260131(10)18F24B0024, (01)10801902172904(17)260131(10)18F24B0027, (01)10801902172904(17)260131(10)18F24B0028, (01)10801902172904(17)260131(10)18F24B0045, (01)10801902172904(17)260131(10)18F24B0046, (01)10801902172904(17)260131(10)18F24B0047, (01)10801902172904(17)260131(10)18F24B0068, (01)10801902172904(17)260131(10)18F24B0069, (01)10801902172904(17)260228(10)18F24B0067, (01)10801902172904(17)260228(10)18F24B0070, (01)10801902172904(17)260228(10)18F24B0071, (01)10801902172904(17)260228(10)18F24C0006, (01)10801902172904(17)260228(10)18F24C0007, (01)10801902172904(17)260228(10)18F24C0028, (01)10801902172904(17)260228(10)18F24C0029, (01)10801902172904(17)260228(10)18F24C0030, (01)10801902172904(17)260228(10)18F24C0038, (01)10801902172904(17)260228(10)18F24C0092, (01)10801902172904(17)260228(10)18F24C0120, (01)10801902172904(17)260228(10)18F24C0121, (01)10801902172904(17)260228(10)18F24C0141; c) REF IAB-06850-U, UDI: (01)10801902144192(17)240831(10)18F22J0020(13)220916, (01)10801902144192(17)240831(10)18F22J0038(13)220928, (01)10801902144192(17)240831(10)18F22J0043(13)220930, (01)10801902144192(17)240930(10)18F22K0001(13)221003, (01)10801902144192(17)240930(10)18F22K0003(13)221004, (01)10801902144192(17)240930(10)18F22K0006(13)221006, (01)10801902144192(17)240930(10)18F22K0011(13)221007, (01)10801902144192(17)240930(10)18F22K0012(13)221007, (01)10801902144192(17)240930(10)18F22K0013(13)221007, (01)10801902144192(17)241231(10)18F23A0075(13)230131, (01)10801902144192(17)250131(10)18F23B0005(13)230203, (01)10801902144192(17)250131(10)18F23B0010(13)230206, (01)10801902144192(17)250131(10)18F23B0029(13)230220, (01)10801902144192(17)250131(10)18F23B0030(13)230220, (01)10801902144192(17)250228(10)18F23C0007(13)230307, (01)10801902144192(17)250228(10)18F23C0008(13)230307, (01)10801902144192(17)250228(10)18F23C0014(13)230310, (01)10801902144192(17)250228(10)18F23C0015(13)230310, (01)10801902144192(17)250531(10)18F23F0016(13)230609, (01)10801902144192(17)250531(10)18F23F0017(13)230609, (01)10801902144192(17)250831(10)18F23J0043(13)230921, (01)10801902144192(17)250831(10)18F23J0044(13)230923, (01)10801902144192(17)250930(10)18F23J0078(13)231031, (01)10801902144192(17)250930(10)18F23K0015(13)231031, (01)10801902144192(17)250930(10)18F23K0024(13)231014, (01)10801902144192(17)251031(10)18F23L0045(13)231130, (01)10801902144192(17)251130(10)18F23L0052(13)231205, (01)10801902144192(17)251130(10)18F23L0058(13)231205, (01)10801902144192(17)260131(10)18F24B0011(13)240209, (01)10801902144192(17)260131(10)18F24B0012(13)240209, (01)10801902172911(17)250831(10)18F23H0061(13)230911, (01)10801902172911(17)260131(10)18F24B0010(13)240207
Recall status
Ongoing — the recall is still being carried out.
Where it was distributed
Worldwide distribution. US nationwide including Puerto Rico, AU, BA, BE, BG, BN, CA, CL, CN, CO, CY, CZ, DE, EC, ES, FR, GB, GP, GR, HU, HK, IE, IL, IN, IQ, IT, JO, JP, KW, KZ, LB, LU, MA, MN, MK, MX, MY, NL, OM, PA, PF, PH, PL, PT, QA, RE, RO, RS, SA, SE, SG, SI, SK, TH, TR, TW, UZ, ZA, and UAE.
Recall record
- Recalling firm
- ARROW INTERNATIONAL Inc.
- Product type
- Devices
- Recall number
- Z-1879-2024
- Voluntary / mandated
- Voluntary: Firm initiated
- Initial notification
- Letter
- Origin
- Morrisville, NC
- Recall initiated
- 2024-04-29
What to do
Check the lot/code above against your product. To confirm this record and read the FDA's full notice, see the FDA recall page. Before changing anything you take or use, ask your pharmacist or prescriber — this page does not tell you to start or stop any drug or device.
Also available: structured data (JSON-LD) · recall record (JSON)
What this is — and is not
A recall is a recorded FDA enforcement action — the FDA logged that a firm is removing or correcting a product. It does not establish that any specific unit harmed anyone, and causation is not established by a recall. The class above is the FDA's risk judgment for the product category, not a finding about your unit. This page informs and compares; it is not medical advice and never tells you to start or stop a drug or device.
To report a problem you experienced, use
FDA MedWatch.
Verify this record at FDA recalls ·
Recall Z-1879-2024 · Source: openFDA enforcement.