Reported Jan 25, 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 Numbers 0998-00-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-00-0800-34, 0998-00-0800-35, 0998-00-0800-36, 0998-00-0800-45, 0998-00-0800-52, 0998-00-0800-53, 0998-00-0800-55, 0998-00-0800-65, 0998-UC-0800-31, 0998-UC-0800-32, 0998-UC-0800-33, 0998-UC-0800-34, 0998-UC-0800-35, 0998-UC-0800-36, 0998-UC-0800-45, 0998-UC-0800-52, 0998-UC-0800-53, 0998-UC-0800-55, 0998-UC-0800-65.
- Lot codes and dates
- All Serial Numbers. May also be designated as part number D998 etc. Model Number
- UDI-DI
0998-00-0800-31106075671090530998-00-0800-32106075671111170998-00-0800-33106075671090530998-00-0800-34106075671119400998-00-0800-35106075671091070998-00-0800-36106075671141870998-00-0800-45106075671084210998-00-0800-52106075671084380998-00-0800-53106075671083910998-00-0800-55106075671084140998-00-0800-65106075671134320998-UC-0800-31106075671090530998-UC-0800-32106075671111170998-UC-0800-33106075671090080998-UC-0800-34106075671119400998-UC-0800-35106075671091070998-UC-0800-36106075671141870998-UC-0800-45106075671084210998-UC-0800-52106075671084380998-UC-0800-53106075671083910998-UC-0800-55106075671084140998-UC-0800-6510607567113432
- Amount recalled
- 11,906 Total
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
The Cardiosave IABP may shut down unexpectedly due to blood entering in the Cardiosave IABP when therapy is provided with a compromised intra-aortic balloon catheter.
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.
Free recall alerts
Get alerted about new Datascope Corp. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.