Reported Dec 22, 2021 · Ongoing
Cardiosave Hybrid IntraAortic Balloon Pump. Model Numbers: 0998-00-0800-31, 0998-UC-0800-31, 0998-00-0800-32,…
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 IntraAortic Balloon Pump
- Model Numbers
0998-00-0800-310998-UC-0800-310998-00-0800-320998-UC-0800-320998-00-0800-330998-UC-0800-330998-00-0800-340998-UC-0800-340998-00-0800-350998-UC-0800-350998-00-0800-360998-UC-0800-360998-00-0800-450998-UC-0800-450998-00-0800-520998-UC-0800-520998-00-0800-530998-UC-0800-530998-00-0800-550998-UC-0800-550998-00-0800-650998-UC-0800-65
- Lot codes and dates
- All Serial Numbers. May also be designated as part number D998 etc. Model Number
- UDI-DI
0998-00-0800-31106075671090530998-UC-0800-31106075671090530998-00-0800-32106075671111170998-UC-0800-32106075671111170998-00-0800-33106075671090080998-UC-0800-33106075671090080998-00-0800-34106075671119400998-UC-0800-34106075671119400998-00-0800-35106075671091070998-UC-0800-35106075671091070998-00-0800-36106075671141870998-UC-0800-36106075671141870998-00-0800-45106075671084210998-UC-0800-45106075671084210998-00-0800-52106075671084380998-UC-0800-52106075671084380998-00-0800-53106075671083910998-UC-0800-53106075671083910998-00-0800-55106075671084140998-UC-0800-55106075671084140998-00-0800-65106075671134320998-UC-0800-6510607567113432
- Amount recalled
- 5,566 (US); 6,354 (OUS)
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
Stop using this product now
Firm is initiating a correction due to the possibility of fluid ingress. Fluid entering the device may short various electronic components thus leading to system shutdown, which could result in unsafe hemodynamic instability.
Using this product could cause serious injury, illness or death — stop using it now.
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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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