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

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, 0998-00-0800-36, 0998-UC-0800-32, 0998-UC-0800-34, 0998-UC-0800-35, 0998-UC-0800-36, 0998-UC-0800-45, 0998-UC-0800-65,

Lot codes and dates: 25 of 25 products
Products covered by this recall
Model / number Barcodes Product as published
0998-00-0800-31 10607567109053 All Lot Numbers. , UDI: 10607567109053
0998-UC-0800-31 UDI: N/A
0998-00-0800-32 10607567111117 UDI: 10607567111117
0998-00-0800-33 10607567109008 UDI: 10607567109008
0998-UC-0800-33 UDI: N/A
0998-00-0800-34 10607567111940 UDI: 10607567111940
0998-00-0800-35 10607567109107 UDI: 10607567109107
0998-00-0800-45 10607567108421 UDI: 10607567108421
0998-00-0800-52 10607567108438 UDI: 10607567108438
0998-UC-0800-52 UDI: N/A
0998-00-0800-53 10607567108391 UDI:10607567108391
0998-UC-0800-53 UDI: N/A
0998-00-0800-55 10607567108414 UDI: 10607567108414
0998-UC-0800-55 UDI: N/A
0998-00-0800-65 10607567113432 UDI: 10607567113432
0998-00-0800-75 10607567112312 UDI: 10607567112312
0998-00-0800-83 10607567108407 UDI: 10607567108407
0998-00-0800-85 10607567113449 UDI: 10607567113449
0998-00-0800-36 10607567114187 UDI: 10607567114187
0998-UC-0800-32 UDI: N/A
Page 1 of 2
Amount recalled: 11574 units (5413 US, 6161 OUS)

The agency filed one notice per product. You are reading one of them; the other 9 are below.

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.

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

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.

20 in total.