Class II — the FDA judged the product may cause temporary or medically reversible harm, with a remote chance of serious harm.
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. Most recalls are Class II or III.
LINEAR 7.5Fr.IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Description Part Number LINEAR 7.5Fr. 34cc IAB WITH ACCESSORIES D684-00-0479-01 LINEAR 7.5Fr. 34cc IAB WITH ACCESSORIES (APA) D684-00-0479-02 LINEAR 7.5Fr. 34cc IAB WITH ACCESSORIES (CHINA) D684-00-0479-01C LINEAR 7.5Fr. 34cc IAB WITH ACCESSORIES (APA)(CHINA) D684-00-0479-02C LINEAR 7.5Fr. 34cc IAB WITH ACCESSORIES (INDIA) D684-00-0479-07 LINEAR 7.5Fr. 34cc IAB WITH ACCESSORIES (APA) (INDIA) D684-00-0479-08 LINEAR 7.5Fr. 34cc IAB WITH ACCESSORIES (TURKEY) D684-00-0479-09 LINEAR 7.5Fr. 34cc IAB WITH ACCESSORIES WITH APA (TURKEY) D684-00-0479-10 LINEAR 7.5Fr. 34cc IAB WITH ACCESSORIES, US ONLY D684-00-0479-01U LINEAR 7.5Fr. 34cc IAB WITH ACCESSORIES, (APA) US ONLY D684-00-0479-02U LINEAR 7.5Fr. 40cc IAB WITH ACCESSORIES D684-00-0480-01 LINEAR 7.5Fr. 40cc IAB WITH ACCESSORIES (APA) D684-00-0480-02 LINEAR 7.5Fr. 40cc IAB WITH ACCESSORIES (CHINA) D684-00-0480-01C LINEAR 7.5Fr. 40cc IAB WITH ACCESSORIES (APA)(CHINA) D684-00-0480-02C LINEAR 7.5Fr. 40cc IAB WITH ACCESSORIES (INDIA) D684-00-0480-07 LINEAR 7.5Fr. 40cc IAB WITH ACCESSORIES (APA)(INDIA) D684-00-0480-08 LINEAR 7.5Fr. 40cc IAB WITH ACCESSORIES (TURKEY) D684-00-0480-09 LINEAR 7.5Fr. 40cc IAB WITH ACCESSORIES WITH APA (TURKEY) D684-00-0480-10 LINEAR 7.5Fr. 40cc IAB WITH ACCESSORIES, US ONLY D684-00-0480-01U LINEAR 7.5Fr. 40cc IAB WITH ACCESSORIES, (APA) US ONLY D684-00-0480-02U LINEAR 7.5Fr. 25cc IAB WITH ACCESSORIES D684-00-0478-01 LINEAR 7.5Fr. 25cc IAB WITH ACCESSORIES (APA) D684-00-0478-02 LINEAR 7.5Fr. 25cc IAB WITH ACCESSORIES (CHINA) D684-00-0478-01C LINEAR 7.5Fr. 25cc IAB WITH ACCESSORIES (APA) (CHINA) D684-00-0478-02C LINEAR 7.5Fr. 25cc IAB WITH ACCESSORIES (INDIA) D684-00-0478-07 LINEAR 7.5Fr. 25cc IAB WITH ACCESSORIES (APA) (INDIA) D684-00-0478-08 LINEAR 7.5Fr. 25cc IAB WITH ACCESSORIES (TURKEY) D684-00-0478-09 LINEAR 7.5Fr. 25cc IAB WITH ACCESSORIES WITH APA (TURKEY) D684-00-0478-10 LINEAR 7.5Fr. 25cc IAB WITH ACCESSORIES, US ONLY D684-00-0478-01U LINEAR 7.5Fr. 25cc IAB WITH ACCESSORIES (APA) US ONLY D684-00-0478-02U PACKAGED INSERTION KIT - LINEAR 7.5 Fr. 25 cc IABs D884-00-0019-12 PACKAGED INSERTION KIT - LINEAR 7.5 Fr. 34/40 cc IABs D884-00-0019-13
Why it was recalled
During IAB catheter insertion, the introducer dilator may fracture at the hub, leaving the body of the introducer dilator housed within the sheath. Risks to health include damage to the femoral artery, descending aorta, or embolization; surgical intervention and delay of IAB therapy may also result. Firm has received 10 complaints, including 3 serious adverse events and 1 patient death.
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
Product Description UDI LINEAR 7.5Fr. 34cc IAB WITH ACCESSORIES 10605767106557 LINEAR 7.5Fr. 34cc IAB WITH ACCESSORIES (APA) 10605767106540 LINEAR 7.5Fr. 34cc IAB WITH ACCESSORIES (CHINA) 10605767109329 LINEAR 7.5Fr. 34cc IAB WITH ACCESSORIES (APA)(CHINA) 10605767109336 LINEAR 7.5Fr. 34cc IAB WITH ACCESSORIES (INDIA) 10605767109695 LINEAR 7.5Fr. 34cc IAB WITH ACCESSORIES (APA) (INDIA) 10605767109701 LINEAR 7.5Fr. 34cc IAB WITH ACCESSORIES (TURKEY) 10605767113180 LINEAR 7.5Fr. 34cc IAB WITH ACCESSORIES WITH APA (TURKEY) 10605767113142 LINEAR 7.5Fr. 34cc IAB WITH ACCESSORIES, US ONLY 10605767109503 LINEAR 7.5Fr. 34cc IAB WITH ACCESSORIES, (APA) US ONLY 10605767109510 LINEAR 7.5Fr. 40cc IAB WITH ACCESSORIES 10607567106564 LINEAR 7.5Fr. 40cc IAB WITH ACCESSORIES (APA) 10607567106571 LINEAR 7.5Fr. 40cc IAB WITH ACCESSORIES (CHINA) 10607567109343 LINEAR 7.5Fr. 40cc IAB WITH ACCESSORIES (APA)(CHINA) 10607567109350 LINEAR 7.5Fr. 40cc IAB WITH ACCESSORIES (INDIA) 10607567109718 LINEAR 7.5Fr. 40cc IAB WITH ACCESSORIES (APA)(INDIA) 10607567109725 LINEAR 7.5Fr. 40cc IAB WITH ACCESSORIES (TURKEY) 10607567113197 LINEAR 7.5Fr. 40cc IAB WITH ACCESSORIES WITH APA (TURKEY) 10607567113159 LINEAR 7.5Fr. 40cc IAB WITH ACCESSORIES, US ONLY 10607567109527 LINEAR 7.5Fr. 40cc IAB WITH ACCESSORIES, (APA) US ONLY 10607567109534 LINEAR 7.5Fr. 25cc IAB WITH ACCESSORIES 10607567106526 LINEAR 7.5Fr. 25cc IAB WITH ACCESSORIES (APA) 10607567106533 LINEAR 7.5Fr. 25cc IAB WITH ACCESSORIES (CHINA) 10607567109305 LINEAR 7.5Fr. 25cc IAB WITH ACCESSORIES (APA) (CHINA) 10607567109312 LINEAR 7.5Fr. 25cc IAB WITH ACCESSORIES (INDIA) 10607567109671 LINEAR 7.5Fr. 25cc IAB WITH ACCESSORIES (APA) (INDIA) 10607567109688 LINEAR 7.5Fr. 25cc IAB WITH ACCESSORIES (TURKEY) 10607567113203 LINEAR 7.5Fr. 25cc IAB WITH ACCESSORIES WITH APA (TURKEY) 10607567113210 LINEAR 7.5Fr. 25cc IAB WITH ACCESSORIES, US ONLY 10607567109480 LINEAR 7.5Fr. 25cc IAB WITH ACCESSORIES (APA) US ONLY 10607567109497 PACKAGED INSERTION KIT - LINEAR 7.5 Fr. 25 cc IABs 10607567106632 PACKAGED INSERTION KIT - LINEAR 7.5 Fr. 34/40 cc IABs 10607567106649
Recall status
Ongoing — the recall is still being carried out.
Where it was distributed
Domestic distribution nationwide. International distribution worldwide.
Recall record
- Recalling firm
- Datascope Corp.
- Product type
- Devices
- Recall number
- Z-2223-2023
- Voluntary / mandated
- Voluntary: Firm initiated
- Initial notification
- N/A
- Origin
- Fairfield, NJ
- Recall initiated
- 2023-06-23
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-2223-2023 · Source: openFDA enforcement.