Reported Mar 15, 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.
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. · 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, 0998-00-0800-45, 0998-00-0800-52, 0998-00-0800-53, 0998-00-0800-55, 0998-00-0800-65, 0998-UC-0800-31, 0998-UC-0800-33, 0998-UC-0800-52, 0998-UC-0800-53, and 0998-00-0800-55
- Lot codes and dates
10 of 10 products
Products covered by this recall Model / number Barcodes Product as published 0998-00-0800-3110607567109053All Serial Numbers. , UDI-DI:10607567109053 0998-00-0800-3210607567111117UDI-DI: 10607567111117 0998-00-0800-3310607567109008UDI-DI: 10607567109008 0998-00-0800-3410607567111940UDI-DI: 10607567111940 0998-00-0800-3510607567109107UDI-DI: 10607567109107 0998-00-0800-4510607567108421UDI-DI: 10607567108421 0998-00-0800-5210607567108438UDI-DI: 10607567108438 0998-00-0800-5310607567108391UDI-DI: 10607567108391 0998-00-0800-5510607567108414UDI-DI: 10607567108414 0998-00-0800-6510607567113432UDI-DI: 10607567113432 - Amount recalled
- 8909 units
This recall covers 8 products
The agency filed one notice per product. You are reading one of them; the other 7 are below.
Where it was sold
- Nationwide
Why it was recalled
There have been reported failures of the high pressure helium regulator, which may cause a helium leak in the Cardiosave Hospital Cart. In instance of helium regulator failure, a Pump Console s internal reservoir of helium will not be replenished when docked into an impacted Hospital Cart. This may result in an insufficient amount of helium within the internal reservoir.
This product could cause temporary or reversible health problems — stop using it.
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.