Z-1386-2017 Class II Terminated
FDA device recall Z-1386-2017 was initiated by Maquet Datascope Corp - Cardiac Assist Division on December 23, 2016 and is designated Class II. Reason for recall: Maquet has received 3 confirmed complaints related to the Li-lon Battery used with the Maquet CARDIOSAVE Hybrid IABP and Maquet CARDIOSAVE Rescue IABP of the battery venting after being accidentally d… The recall status is terminated (terminated March 1, 2019). Affected quantity: 8000.
Recall Details
- Product Type
- Devices
- Report Date
- March 8, 2017
- Initiation Date
- December 23, 2016
- Termination Date
- March 1, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 8000
Product Description
CARDIOSAVE Hybrid IABP and CARDIOSAVE Rescue IABP affected part number is 0998-:XX-0800-XX Li-Ion Battery affected part number is 0146-00-0097 Product Usage: The CARDIOSAVE Hybrid Intra-Aortic Balloon Pump (IABP) is an electromechanical system used to inflate and deflate intra-aortic balloons
Reason for Recall
Maquet has received 3 confirmed complaints related to the Li-lon Battery used with the Maquet CARDIOSAVE Hybrid IABP and Maquet CARDIOSAVE Rescue IABP of the battery venting after being accidentally dropped.
Distribution Pattern
Worldwide Distribution - US Nationwide
Code Information
part number 0146-00-0097