Reported Mar 15, 2023 · Ongoing
Cardiosave Hybrid Model Nos. 0998-00-0800-31 0998-00-0800-32 0998-00-0800-33 0998-00-0800-34 0998-00-0800-35…
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 Model Nos.0998-UC-0800-31* 0998-UC-0800-33* 0998-UC-0800-52* 0998-UC-0800-53* 0998-00-0800-55* * -- not distributed in US
0998-00-0800-310998-00-0800-320998-00-0800-330998-00-0800-340998-00-0800-350998-00-0800-450998-00-0800-520998-00-0800-530998-00-0800-550998-00-0800-65
- Lot codes and dates
- Model UDI0998-UC-0800-31* N/A 0998-UC-0800-33* N/A 0998-UC-0800-52* N/A 0998-UC-0800-53* N/A 0998-00-0800-55* N/A All serial numbers
0998-00-0800-31106075671090530998-00-0800-32106075671111170998-00-0800-33106075671090080998-00-0800-34106075671119400998-00-0800-35106075671091070998-00-0800-45106075671084210998-00-0800-52106075671084380998-00-0800-53106075671083910998-00-0800-55106075671084140998-00-0800-6510607567113432
- Model UDI
- Amount recalled
- 4793 (US); 4407 (OUS)
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
Why it was recalled
Stop using this product now
An unexpected shutdown of the IABP may occur due to loss of communication between the Executive Processor PCBA and the Video Generator PCBA. This may result in an interruption to therapy which may threaten the hemodynamic stability of the supported patient as the user is left unaware to the status of the Cardiosave IABP.
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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