Reported Oct 2, 2024 · Ongoing
CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to inflate and deflate intra-aortic…
Datascope Corp.
High riskUsing this product could cause serious injury, illness or death — stop using it now.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. · 1300 Macarthur Blvd · Mahwah, NJ · 07430-2052
Is this the product you have?
- CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to inflate and deflate intra-aortic balloons.
- Lot codes and dates
Product No. 0998-00-0800-310998-UC-0800-310998-00-0800-320998-00-0800-330998-UC-0800-330998-00-0800-340998-00-0800-350998-00-0800-360998-00-0800-450998-00-0800-520998-UC-0800-520998-00-0800-530998-UC-0800-530998-00-0800-550998-UC-0800-550998-00-0800-65
- UDI
1060756710905310607567111117106075671090081060756711194010607567109107106075671141871060756710842110607567108438106075671083911060756710841410607567113432Lot No. ALL LOTS
- Amount recalled
- 5,475 units
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Why it was recalled
Stop using this product now
Firm has developed a software correction (Revision D.01) for outside the US to mitigate product problems that pose a risk of hemodynamic instability and failure of transmission of clinical data in Cardiosave Hybrid and Cardiosave Rescue Intra-Aortic Balloon Pump devices.
Using this product could cause serious injury, illness or death — stop using it now.
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.
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