Reported Aug 2, 2023 · Ongoing
SENSATION 7 Fr. IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the…
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?
11 of 11 products
| Model / number | Product as published |
|---|---|
D684-00-0469-01C | SENSATION 7 Fr. IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Description Part Number SENSATION 7 Fr. 34cc IAB WITH ACCESSORIES (CHINA) |
D684-00-0469-07 | SENSATION 7 Fr. 34cc IAB WITH ACCESSORIES (INDIA) |
D684-00-0470-01C | SENSATION 7 Fr. 40cc IAB WITH ACCESSORIES (CHINA) |
D684-00-0470-07 | SENSATION 7 Fr. 40cc IAB WITH ACCESSORIES (INDIA) |
D684-00-0470-09 | SENSATION 7 Fr. 40cc IAB WITH ACCESSORIES (TURKEY) |
D684-00-0470-01 | SENSATION 7 Fr. 40cc IAB WITH ACCESSORIES |
D684-00-0470-01U | SENSATION 7 Fr. 40cc IAB WITH ACCESSORIES, US ONLY |
D684-00-0469-01U | SENSATION 7 Fr. 34cc IAB WITH ACCESSORIES, US ONLY |
D684-00-0469-01 | SENSATION 7 Fr. 34cc IAB WITH ACCESSORIES |
D684-00-0469-09 | SENSATION 7 Fr. 34cc IAB WITH ACCESSORIES, TURKEY |
D884-00-0019-16 | PACKAGED INSERTION KIT - SENSATION 7 Fr. 34/40 cc IABs |
- Lot codes and dates
- Product Description UDI SENSATION 7 Fr. 34cc IAB WITH ACCESSORIES (CHINA) 10607567109367 SENSATION 7 Fr. 34cc IAB WITH ACCESSORIES (INDIA) 10607567109732 SENSATION 7 Fr. 40cc IAB WITH ACCESSORIES (CHINA) 10607567109374 SENSATION 7 Fr. 40cc IAB WITH ACCESSORIES (INDIA) 10607567109749 SENSATION 7 Fr. 40cc IAB WITH ACCESSORIES (TURKEY) 10607567113135 SENSATION 7 Fr. 40cc IAB WITH ACCESSORIES 10607567106779 SENSATION 7 Fr. 40cc IAB WITH ACCESSORIES, US ONLY 10607567109558 SENSATION 7 Fr. 34cc IAB WITH ACCESSORIES, US ONLY 10607567109541 SENSATION 7 Fr. 34cc IAB WITH ACCESSORIES 10607567106755 SENSATION 7 Fr. 34cc IAB WITH ACCESSORIES, TURKEY 10607567113128 PACKAGED INSERTION KIT - SENSATION 7 Fr. 34/40 cc IABs 10607567106724
- 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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