Reported Aug 2, 2023 · Ongoing
REINFORCED INTRODUCER SET, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in…
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?
3 of 3 products
| Model / number | Product as published |
|---|---|
D684-00-0403-05 | REINFORCED INTRODUCER SET, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Description Part Number REINFORCED INTRODUCER SET FOR LINEAR 7.5Fr. & MEGA 7.5Fr. |
D684-00-0403-06 | REINFORCED INTRODUCER SET FOR SENSATION 7Fr. |
D684-00-0403-10 | REINFORCED INTRODUCER SET FOR SENSATION PLUS & MEGA 8Fr. |
- Lot codes and dates
3 of 3 products
Products covered by this recall Model / number Barcodes Product as published 7.5Fr.10607567106656REINFORCED INTRODUCER SET FOR SENSATION 7Fr.10607567106694REINFORCED INTRODUCER SET FOR SENSATION PLUS & MEGA 8Fr.10607567107943— - 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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