Reported Aug 2, 2023 · Ongoing
MEGA 8Fr. 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?
10 of 10 products
| Model / number | Product as published |
|---|---|
D684-00-0296-01 | MEGA 8Fr. IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Description Part Number MEGA 8Fr. 50cc IAB WITH STATLOCK |
D684-00-0296-02 | MEGA 8Fr. 50cc IAB WITH STATLOCK & APA |
D684-00-0296-03 | MEGA 8Fr. 50cc IAB WITH ACCESSORIES (W/O STATLOCK) |
D684-00-0296-09 | MEGA 8Fr. 50cc IAB WITH ACCESSORIES (TURKEY) |
D684-00-0296-10 | MEGA 8Fr. 50cc IAB WITH ACCESSORIES WITH APA (TURKEY) |
D684-00-0296-01U | MEGA 8Fr. 50cc IAB WITH ACCESSORIES, US ONLY |
D684-00-0296-02U | MEGA 8Fr. 50cc IAB WITH ACCESSORIES, (APA) US ONLY |
D684-00-0498-01 | MEGA 8Fr. 50cc IAB WITH ACCESSORIES (CHINA) |
D684-00-0498-07 | MEGA 8Fr. 50cc IAB WITH ACCESSORIES (INDIA) |
D684-00-0498-08 | MEGA 8Fr. 50cc IAB WITH ACCESSORIES (APA) (INDIA) |
- Lot codes and dates
- Product Description UDI MEGA 8Fr. 50cc IAB WITH STATLOCK 10607567108001 MEGA 8Fr. 50cc IAB WITH STATLOCK & APA 10607567108018 MEGA 8Fr. 50cc IAB WITH ACCESSORIES (W/O STATLOCK) 10607567109411 MEGA 8Fr. 50cc IAB WITH ACCESSORIES (TURKEY) 10607567113265 MEGA 8Fr. 50cc IAB WITH ACCESSORIES WITH APA (TURKEY) 10607567113272 MEGA 8Fr. 50cc IAB WITH ACCESSORIES, US ONLY 10607567109619 MEGA 8Fr. 50cc IAB WITH ACCESSORIES, (APA) US ONLY 10607567109626 MEGA 8Fr. 50cc IAB WITH ACCESSORIES (CHINA) 10607567107301 MEGA 8Fr. 50cc IAB WITH ACCESSORIES (INDIA) 10607567109756 MEGA 8Fr. 50cc IAB WITH ACCESSORIES (APA) (INDIA) 10607567109763 PACKAGED INSERTION KIT - MEGA 8 Fr. 50 cc IAB 10607567107493
- 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.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Datascope Corp. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.