Reported Aug 2, 2023 · Ongoing
MEGA 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?
20 of 20 products
| Model / number | Product as published |
|---|---|
D684-00-0295-01 | MEGA 7.5Fr.IAB , Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Description Part Number MEGA 7.5Fr. 40cc IAB WITH ACCESSORIES |
D684-00-0295-02 | MEGA 7.5Fr. 40cc IAB WITH ACCESSORIES (APA) |
D684-00-0295-03 | MEGA 7.5Fr. 40cc IAB WITH ACCESSORIES (W/O STATLOCK) |
D684-00-0295-05 | MEGA 7.5Fr. 40cc IAB WITH ACCESSORIES (CHINA) |
D684-00-0295-06 | MEGA 7.5Fr. 40cc IAB WITH ACCESSORIES AND APA (CHINA) |
D684-00-0295-07 | MEGA 7.5Fr. 40cc IAB WITH ACCESSORIES W/O STATLOCK - INDIA |
D684-00-0295-09 | MEGA 7.5Fr. 40cc IAB WITH ACCESSORIES W/O STATLOCK (APA) - INDIA D684-00-0295-08 MEGA 7.5Fr. 40cc IAB WITH ACCESSORIES (TURKEY) |
D684-00-0295-10 | MEGA 7.5Fr. 40cc IAB WITH ACCESSORIES (APA) (TURKEY) |
D684-00-0295-01U | MEGA 7.5Fr. 40cc IAB WITH ACCESSORIES, US ONLY |
D684-00-0295-02U | MEGA 7.5Fr. 40cc IAB WITH ACCESSORIES APA, US ONLY |
D684-00-0294-01 | MEGA 7.5Fr. 30cc IAB WITH ACCESSORIES |
D684-00-0294-02 | MEGA 7.5Fr. 30cc IAB WITH ACCESSORIES (APA) |
D684-00-0294-03 | MEGA 7.5Fr. 30cc IAB WITH ACCESSORIES (W/O STATLOCK) |
D684-00-0294-05 | MEGA 7.5Fr. 30cc IAB WITH ACCESSORIES (CHINA) |
D684-00-0294-06 | MEGA 7.5Fr. 30cc IAB WITH ACCESSORIES AND APA (CHINA) |
D684-00-0294-07 | MEGA 7.5Fr. 30cc IAB WITH ACCESSORIES W/O STATLOCK - INDIA |
D684-00-0294-09 | MEGA 7.5Fr. 30cc IAB WITH ACCESSORIES W/O STATLOCK (APA) INDIA D684-00-0294-08 MEGA 7.5Fr. 30cc IAB WITH ACCESSORIES (TURKEY) |
D684-00-0294-10 | MEGA 7.5Fr. 30cc IAB WITH ACCESSORIES (APA) (TURKEY) |
D684-00-0294-01U | MEGA 7.5Fr. 30cc IAB WITH ACCESSORIES, US ONLY |
D684-00-0294-02U | MEGA 7.5Fr. 30cc IAB WITH ACCESSORIES APA, US ONLY |
- Lot codes and dates
- Product Description UDI MEGA 7.5Fr. 40cc IAB WITH ACCESSORIES 10607567107974 MEGA 7.5Fr. 40cc IAB WITH ACCESSORIES (APA) 10607567107981 MEGA 7.5Fr. 40cc IAB WITH ACCESSORIES (W/O STATLOCK) 10607567109404 MEGA 7.5Fr. 40cc IAB WITH ACCESSORIES (CHINA) 10607567109039 MEGA 7.5Fr. 40cc IAB WITH ACCESSORIES AND APA (CHINA) 10607567109046 MEGA 7.5Fr. 40cc IAB WITH ACCESSORIES W/O STATLOCK - INDIA 10607567111339 MEGA 7.5Fr. 40cc IAB WITH ACCESSORIES W/O STATLOCK (APA) - INDIA 10607567111346 MEGA 7.5Fr. 40cc IAB WITH ACCESSORIES (TURKEY) 10607567113241 MEGA 7.5Fr. 40cc IAB WITH ACCESSORIES (APA) (TURKEY) 10607567113258 MEGA 7.5Fr. 40cc IAB WITH ACCESSORIES, US ONLY 10605767109596 MEGA 7.5Fr. 40cc IAB WITH ACCESSORIES APA, US ONLY 10605767109602 MEGA 7.5Fr. 30cc IAB WITH ACCESSORIES 10607567107950 MEGA 7.5Fr. 30cc IAB WITH ACCESSORIES (APA) 10607567107967 MEGA 7.5Fr. 30cc IAB WITH ACCESSORIES (W/O STATLOCK) 10607567109398 MEGA 7.5Fr. 30cc IAB WITH ACCESSORIES (CHINA) 10607567109015 MEGA 7.5Fr. 30cc IAB WITH ACCESSORIES AND APA (CHINA) 10607567109022 MEGA 7.5Fr. 30cc IAB WITH ACCESSORIES W/O STATLOCK - INDIA 10607567111315 MEGA 7.5Fr. 30cc IAB WITH ACCESSORIES W/O STATLOCK (APA) INDIA 10607567111322 MEGA 7.5Fr. 30cc IAB WITH ACCESSORIES (TURKEY) 10607567113227 MEGA 7.5Fr. 30cc IAB WITH ACCESSORIES (APA) (TURKEY) 10607567113234 MEGA 7.5Fr. 30cc IAB WITH ACCESSORIES, US ONLY 10607567109572 MEGA 7.5Fr. 30cc IAB WITH ACCESSORIES APA, US ONLY 10607567109589 PACKAGED INSERTION KIT - MEGA 7.5 Fr. 30/40 cc IABs 10607567108025
- 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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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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