Reported Sep 6, 2023 · Ongoing
Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85,…
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 Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85, 0998-UC-0800-75, 0998-UC-0800-83, 0998-UC-0800-85,
- Lot codes and dates
5 of 5 products
Products covered by this recall Model / number Barcodes Product as published 0998-00-0800-7510607567112312All Lot Numbers. , UDI: 10607567112312 0998-00-0800-8310607567108407UDI: 10607567108407 0998-UC-0800-7510607567113449Model: 0998-00-0800-85, UDI: 10607567113449, , UDI: N/A 0998-UC-0800-83UDI: N/A 0998-UC-0800-85UDI: N/A - Amount recalled
- 47 units (42 US, 5 OUS)
This recall covers 10 products
The agency filed one notice per product. You are reading one of them; the other 9 are below.
Where it was sold
- Nationwide
Why it was recalled
Stop using this product now
Users reported "System Over Temperature" alarms associated with a loss of pumping and/or the Cardiosave system entering Standby mode.
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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