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.
DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12113 LV VENT 13FR, Model Number 12113
Why it was recalled
The catheters may not retain their shape.
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
UDI-DI: 20643169881338, 00673978176475, 00643169881334; Serial Numbers: 2023051188 2023060142 2023060144 2023060431 2023060762 2023061146 2023061146 2023070147 2023070147 2023070148 2023070148 2023070149 2023070149 2023070150 2023070150 2023070151 2023070490 2023070490 2023070979 2023080156 2023080797 2023080798 2023080798 2023081130 2023081131 2023081131 2023081132 2023081547 2023081548 2023081548 2023090234 2023090235 2023090427 2023090675 2023090979 2023090980 2023091104 2023091105 2023091105 2023091106 2023091106 2023100243 2023100243 2023100244 2023100641 2023100641 2023100642 2023101024 2023101025 2023101025 2023101365 2023101365 2023101366 2023110247 2023110308 2023110308 2023110312 2023110312 2023121249 2023121250 2023121250 2023121251 2023121251 2023121251 2023121252 2023121253 2023121254 2023121255 2024010470 2024010471 2024010472 2024010472 2024010473 2024010474 2024010474 2024010475 2024010475 2024010476 2024010476 2024010477 2024011016 2024011016 2024011214 2024031093 2024031094 2024031095 2024040067 2024040068 2024040068 2024040069 2024040070 2024040071 2024040245 2024040245 2024060793 202307C112 202308C248 202308C249 202309C022 202310C057 202310C058 202312C203 202402C086 202403C085 202403C086 202403C087 202406C057 202407C109
Recall status
Ongoing — the recall is still being carried out.
Where it was distributed
Worldwide - US Nationwide distribution.
Recall record
- Recalling firm
- Medtronic Perfusion Systems
- Product type
- Devices
- Recall number
- Z-2480-2025
- Voluntary / mandated
- Voluntary: Firm initiated
- Initial notification
- Letter
- Origin
- Brooklyn Park, MN
- Recall initiated
- 2025-08-06
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-2480-2025 · Source: openFDA enforcement.