Reported Aug 2, 2023 · Ongoing
LINEAR 7.5Fr.IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta…
Datascope Corp.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Datascope Corp. · 15 Law Dr Unit 1 · Fairfield, NJ · 07004-3206
Is this the product you have?
32 of 32 products
| Model / number | Product as published |
|---|---|
D684-00-0479-01 | 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 |
D684-00-0479-02 | LINEAR 7.5Fr. 34cc IAB WITH ACCESSORIES (APA) |
D684-00-0479-01C | LINEAR 7.5Fr. 34cc IAB WITH ACCESSORIES (CHINA) |
D684-00-0479-02C | LINEAR 7.5Fr. 34cc IAB WITH ACCESSORIES (APA)(CHINA) |
D684-00-0479-07 | LINEAR 7.5Fr. 34cc IAB WITH ACCESSORIES (INDIA) |
D684-00-0479-08 | LINEAR 7.5Fr. 34cc IAB WITH ACCESSORIES (APA) (INDIA) |
D684-00-0479-09 | LINEAR 7.5Fr. 34cc IAB WITH ACCESSORIES (TURKEY) |
D684-00-0479-10 | LINEAR 7.5Fr. 34cc IAB WITH ACCESSORIES WITH APA (TURKEY) |
D684-00-0479-01U | LINEAR 7.5Fr. 34cc IAB WITH ACCESSORIES, US ONLY |
D684-00-0479-02U | LINEAR 7.5Fr. 34cc IAB WITH ACCESSORIES, (APA) US ONLY |
D684-00-0480-01 | LINEAR 7.5Fr. 40cc IAB WITH ACCESSORIES |
D684-00-0480-02 | LINEAR 7.5Fr. 40cc IAB WITH ACCESSORIES (APA) |
D684-00-0480-01C | LINEAR 7.5Fr. 40cc IAB WITH ACCESSORIES (CHINA) |
D684-00-0480-02C | LINEAR 7.5Fr. 40cc IAB WITH ACCESSORIES (APA)(CHINA) |
D684-00-0480-07 | LINEAR 7.5Fr. 40cc IAB WITH ACCESSORIES (INDIA) |
D684-00-0480-08 | LINEAR 7.5Fr. 40cc IAB WITH ACCESSORIES (APA)(INDIA) |
D684-00-0480-09 | LINEAR 7.5Fr. 40cc IAB WITH ACCESSORIES (TURKEY) |
D684-00-0480-10 | LINEAR 7.5Fr. 40cc IAB WITH ACCESSORIES WITH APA (TURKEY) |
D684-00-0480-01U | LINEAR 7.5Fr. 40cc IAB WITH ACCESSORIES, US ONLY |
D684-00-0480-02U | LINEAR 7.5Fr. 40cc IAB WITH ACCESSORIES, (APA) US ONLY |
- Lot codes and dates
- 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
- Amount recalled
- 321,609 total kits
This recall covers 9 products
The agency filed one notice per product. You are reading one of them; the other 8 are below.
Where it was sold
- Nationwide
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.
This product could cause temporary or reversible health problems — stop using it.
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