Reported Aug 2, 2023 · Ongoing
TRANS-RAY 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?
6 of 6 products
| Model / number | Product as published |
|---|---|
D684-00-0545-01 | TRANS-RAY IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Description Part Number 7FR. 34cc TRANS-RAY IAB WITH ACCESSORIES |
D684-00-0546-01 | TRANS-RAY 7FR. 40cc IAB WITH ACCESSORIES |
D684-00-0607 | TRANS-RAY PLUS 7.5Fr 35cc IAB WITH ACCESSORIES |
D684-00-0608 | TRANS-RAY PLUS 7.5Fr 40cc IAB WITH ACCESSORIES |
D884-00-0019-18 | PACKAGED INSERTION KIT - TRANS-RAY 7 Fr. 34/40 cc IABs |
D884-00-0019-26 | PACKAGED INSERTION KIT - TRANS-RAY PLUS 7.5 Fr. 35/40 IABs |
- Lot codes and dates
- Product Description UDI 7FR. 34cc TRANS-RAY IAB WITH ACCESSORIES 10607567107656 TRANS-RAY 7FR. 40cc IAB WITH ACCESSORIES 10607567107663 TRANS-RAY PLUS 7.5Fr 35cc IAB WITH ACCESSORIES 10607567111711 TRANS-RAY PLUS 7.5Fr 40cc IAB WITH ACCESSORIES 10607567111728 PACKAGED INSERTION KIT - TRANS-RAY 7 Fr. 34/40 cc IABs 10607567107684 PACKAGED INSERTION KIT - TRANS-RAY PLUS 7.5 Fr. 35/40 IABs 10607567111810
- 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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