Reported Dec 24, 2025 · Ongoing
Cardiosave Hybrid
Datascope Corp.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.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
- Lot codes and dates
10 of 10 products
Products covered by this recall Model / number Barcodes Product as published 0998-00-0800-3110607567109053UDI-DI: 10607567109053; Serial Numbers: All 0998-00-0800-3210607567111117UDI-DI: 10607567111117; Serial Numbers: All 0998-00-0800-53106075671090081060756710910710607567114187106075671084211060756710843810607567108391Model: 0998-00-0800-33; UDI-DI: 10607567109008; Serial Numbers: All; 4)Model: 0998-00-0800-35; UDI-DI: 10607567109107; Serial Numbers: All; 5)Model: 0998-00-0800-36; UDI-DI: 10607567114187; Serial Numbers: All; 6)Model: 0998-00-0800-45; UDI-DI: 10607567108421; Serial Numbers: All; 7)Model: 0998-00-0800-52; UDI-DI: 10607567108438; Serial Numbers: All; 8) ; UDI-DI: 10607567108391; Serial Numbers: All 0998-00-0800-5510607567108414UDI-DI: 10607567108414; Serial Numbers: All 0998-00-0800-6510607567113432UDI-DI: 10607567113432; Serial Numbers: All 0998-UC-0800-3110607567109053UDI-DI: 10607567109053; Serial Numbers: All 0998-UC-0800-3310607567109008UDI-DI: 10607567109008; Serial Numbers: All 0998-UC-0800-5210607567108438UDI-DI: 10607567108438; Serial Numbers: All 0998-UC-0800-5310607567108391UDI-DI: 10607567108391; Serial Numbers: All 0998-UC-0800-5510607567108414UDI-DI: 10607567108414; Serial Numbers: All - Amount recalled
- 11470 units (5095 US, 6375 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
The IFU addendum updates the Vibration and Shock Table to reference the correct standards.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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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