FDA Recall Open, Classified

Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Nos. 0998-00-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-00-0800-34, 0998-00-0800-35, 0998-00-0800-45, 0998-00-0800-52, 0998-00-0800-53, 0998-00-0800-55, 0998-00-0800-65

Recall: Z-0075-2022 · Initiated September 8, 2021

Recall

Recall Number: Z-0075-2022
Event Number: 88651
Firm: Datascope Corp.
FEI Number: 3001418283
Product Code: DSP
Status: Open, Classified
Root Cause: Device Design
Initiated: September 8, 2021
Posted: October 7, 2021
Address: 1300 Macarthur Blvd, Mahwah, NJ, 07430-2052

Description

Reason

The Helium Indicator on the Cardiosave display may over represent the amount of helium in unit in the presence of Electromagnetic Interference.

Action

On Wednesday, September 8, 2021, the firm distributed Urgent Medical Device Correction letters to affected customers. Customers were informed that all lots of Maquet Cardiosave Hybrid and Maquet Cardiosave Rescue experience the following issue: Helium Indicator Inaccuracy in the Presence of Continuous EMC Disturbances. Customers were provided with actions to take to limit the possibility of loss of therapy due to an over-reporting of remaining helium on the Helium Indicator. Cardiosave Hybrid users should view the mechanical gauge on the Cardiosave Top Panel to assess remaining helium capacity in case of suspected EMC disturbances. Cardiosave Rescue users should ensure the internal helium reservoir is full prior to use of the device. If the on-screen helium indicator is not showing full, fill the internal helium reservoir via the hospital cart or Helium Refilling Station. Please review the Cardiosave IABP Operation Transport Quick Reference Guide (0002-08-9772) for details on using the Cardiosave Rescue in transport. For both devices: Where practical maximize separation of Cardiosave system from other electronic equipment, communication devices and cables (e.g. power and communication cables). In particular, follow the recommended separation distances between communications equipment and the Cardiosave equipment as specified in the Cardiosave Operating instructions manual. The firm is developing a hardware correction to address this issue. A Datascope/Getinge service representative will contact customers to schedule the installation of the correction when available. The correction approximately will begin late Q2 2022. If you have any questions, please contact your Datascope/Getinge representative or call the Datascope/Getinge Technical Support at 1-888-943-8872, options 4, 2, 1, Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m. (Eastern Time Zone).

Distribution

Worldwide distribution - US Nationwide distribution.

Quantity

5054 total (US), 5033 total (OUS)