Cardiosave Hybrid and rescue IABP
This recall has been terminated (originally issued December 16, 2015).
- Recall Initiated
- December 16, 2015
- Terminated
- June 1, 2018
- Recall Number
- Z-1248-2016
- Quantity
- 1243 units US; 1107 units OUS
- Firm Location
- Mahwah, NJ
- Official Source
- View on FDA website ↗
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
Worldwide Distribution- Nationwide Distribution including Puerto Rico.
Lot / Code Info
Cardiosave Hybrid IABP 0998-00-0800-53,0998-UC-0800-53, Cardiosave Rescue IABP 0998-00-0800-83 & 0998-UC-0800-83
Root Cause
Other
Action Taken
Maquet sent an "Urgent - Medical Device Field Correction Notice and Response form dated December 16, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers are informed of the issues and provided corrective actions. Customers are asked to completed the attached response form in order to return to 1-973-629-1518, or via email to cardiosavescroll@maquet.com. Questions can be directed 1-800-777-4222, option 3, Monday through Friday 8 am-6 pm. EST.