Reported Jul 26, 2023 · Ongoing
Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model numbers 0998-00-0800-31 0998-00-0800-32 0998-00-0800-33…
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), Model numbers0998-UC-0800-31* 0998-UC-0800-33* 0998-UC-0800-52* 0998-UC-0800-53* 0998-00-0800-55* *Not US distribution
0998-00-0800-310998-00-0800-320998-00-0800-330998-00-0800-340998-00-0800-350998-00-0800-450998-00-0800-520998-00-0800-530998-00-0800-550998-00-0800-65
- Lot codes and dates
- All Unit Serial Numbers Model UDI
0998-00-0800-31106075671090530998-00-0800-32106075671111170998-00-0800-33106075671090080998-00-0800-34106075671119400998-00-0800-35106075671091070998-00-0800-45106075671084210998-00-0800-52106075671084380998-00-0800-53106075671083910998-00-0800-55106075671084140998-00-0800-6510607567113432
- All Unit Serial Numbers Model UDI
- Amount recalled
- 9174 (4586 US; 4588 OUS) in total
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
- Nationwide
Why it was recalled
Stop using this product now
An unexpected shutdown of the IABP may occur due to failures of tantalum capacitors in the Power Management Board and/or Solenoid Board. This issue may lead to an unexpected interruption of therapy.
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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