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.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

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

Lot codes and dates: 18 of 18 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
Amount recalled: 9379 units

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

Users were experiencing a failure in the IAB Fiber Optic Sensor input on the IABP when inserting the Intra-Aortic Balloon Fiber Optic connector.

This product could cause temporary or reversible health problems — stop using it.

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.