Reported Sep 6, 2023 · Ongoing
Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-31, 0998-UC-0800-31, 0998-00-0800-32,…
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 Pumps (IABP), Part Numbers 0998-00-0800-31, 0998-UC-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-UC-0800-33, 0998-00-0800-34, 0998-00-0800-35, 0998-00-0800-45, 0998-00-0800-52, 0998-UC-0800-52, 0998-00-0800-53, 0998-UC-0800-53, 0998-00-0800-55, 0998-UC-0800-55, 0998-00-0800-65
- Lot codes and dates
18 of 18 products
Products covered by this recall Model / number Barcodes Product as published 0998-00-0800-3110607567109053All Lot Numbers. , UDI: 10607567109053 0998-UC-0800-31UDI: N/A 0998-00-0800-3210607567111117UDI: 10607567111117 0998-00-0800-3310607567109008UDI: 10607567109008 0998-UC-0800-33UDI: N/A 0998-00-0800-3410607567111940UDI: 10607567111940 0998-00-0800-3510607567109107UDI: 10607567109107 0998-00-0800-4510607567108421UDI: 10607567108421 0998-00-0800-5210607567108438UDI: 10607567108438 0998-UC-0800-52UDI: N/A 0998-00-0800-5310607567108391UDI:10607567108391 0998-UC-0800-53UDI: N/A 0998-00-0800-5510607567108414UDI: 10607567108414 0998-UC-0800-55UDI: N/A 0998-00-0800-6510607567113432UDI: 10607567113432 0998-00-0800-7510607567112312UDI: 10607567112312 0998-00-0800-8310607567108407UDI: 10607567108407 0998-00-0800-8510607567113449UDI: 10607567113449 - Amount recalled
- 9175 units
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 were reporting that the device was not charging as expected. It was discovered that users were unaware that the Cardiosave console was not completely inserted into the hospital cart. If the console is not fully inserted back into the cart the battery(ies) will not charge.
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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