FDA Recall Open, Classified

Cardiosave Li-Ion Battery Pack, Part No. 0146-00-0097. Component of the Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP) with the below Model Numbers. 1. Cardiosave Hybrid. Model Numbers: 0998-00-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-00-0800-35, 0998-00-0800-36, 0998-00-0800-45, 0998-00-0800-52, 0998-00-0800-53, 0998-00-0800-55, 0998-00-0800-65, 0998-UC-0800-31, 0998-UC-0800-33, 0998-UC-0800-52, 0998-UC-0800-53, 0998-UC-0800-55. 2. Cardiosave Rescue. Model Number: 0998-00-0800-83.

Recall: Z-0091-2022 · Initiated September 21, 2021

Recall

Recall Number: Z-0091-2022
Event Number: 88719
Firm: Datascope Corp.
FEI Number: 3001418283
Product Code: DSP
Status: Open, Classified
Root Cause: Nonconforming Material/Component
Initiated: September 21, 2021
Posted: October 20, 2021
Address: 1300 Macarthur Blvd, Mahwah, NJ, 07430-2052

Description

Reason

A Cardiosave Lithium-Ion Battery Pack used during protocol testing failed to meet the minimum runtime requirement per Getinge internal Product Specification. These nonconforming batteries were inadvertently released to customers.

Action

On September 21, 2021, the firm distributed Urgent Medical Device Removal letters to affected customers. Customers were alerted that affected battery packs may experience unexpected short battery runtime. Actions to be Taken by Customer: - Examine your inventory to determine if you have any of the affected product - Replace any affected battery with an unaffected battery, and remove affected product from areas of use - Dispose of affected batteries properly in accordance with local statutes and the labeling on the battery pack - Customers with affected product are eligible for credit or replacement at no cost - Forward information to all current and potential Cardiosave Hybrid and Cardiosave Rescue IABP users within your hospital/facility - Distributors should forward notification to affected customers - Respond to firm's notification by completing the included response form On 11/04/2025, Datascope Getinge sent a customer update letter (i.e. Urgent Medical Device Correction) to communicate the IFU Addendum to consignees on 11/04/2025. The addendum communicates changes regarding the battery run time specification. The IFU Addendum updates the battery runtime specification to match those published in the Service Manual in June 2023. The notification also includes information regarding other issues related to the recall and being communicated to users of the Cardiosave pumps.

Distribution

Worldwide distribution. US nationwide, Australia, Brazil, Bahrain, Belgium, Canada, China, Czech Republic, Egypt, France, Germany, India, Ireland, Italy, Japan, Kuwait, Netherlands, Norway, Pakistan, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, UK, United Arab Emirates, Philippines, and Russia

Quantity

131 batteries, 11,517 pumps