Z-1248-2016 Class II Terminated
FDA device recall Z-1248-2016 was initiated by Maquet Datascope Corp - Cardiac Assist Division on December 16, 2015 and is designated Class II. Reason for recall: Maquet has recieved information that in some Cardiosave IABPS, the scroll compressor did not meet the specifications for output pressure or vacuum at specific flow rates. The recall status is terminated (terminated June 1, 2018). Affected quantity: 1243 units US; 1107 units OUS.
Recall Details
- Product Type
- Devices
- Report Date
- April 6, 2016
- Initiation Date
- December 16, 2015
- Termination Date
- June 1, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1243 units US; 1107 units OUS
Product Description
Cardiosave Hybrid and rescue IABP
Reason for Recall
Maquet has recieved information that in some Cardiosave IABPS, the scroll compressor did not meet the specifications for output pressure or vacuum at specific flow rates.
Distribution Pattern
Worldwide Distribution- Nationwide Distribution including Puerto Rico.
Code Information
Cardiosave Hybrid IABP 0998-00-0800-53,0998-UC-0800-53, Cardiosave Rescue IABP 0998-00-0800-83 & 0998-UC-0800-83