Cardiosave Hybrid and rescue IABP
Hazard
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.
What You Should Do
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.
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Products
- Brand
- Maquet Datascope Corp Cardiac Assist Division
- UPC
- Cardiosave Hybrid IABP 0998-00-0800-53,0998-UC-0800-53, Cardiosave Rescue IABP 0998-00-0800-83 & 0998-UC-0800-83
Units Affected
1243 units US; 1107 units OUS