Device product
CentriMag Acute Circulatory Support System Motor, U.S. Model 102956 and OUS Model 201-10002, a component of the CentriMag Extracorporeal Blood Pumping System.
Z-0221-2020
Product summary
- Event
- Event 83895
- Status
- Terminated
- Classification
- Class I
- Quantity
- 664 units (381 U.S. and 283 OUS)
- Official record key
device-enforcement:Z-0221-2020
Official wording
Reason: Reports have been received of the CentriMag Systems experiencing motor and pump issues resulting from electromagnetic interference (EMI).
Code information: U.S. Model 102956 UDI: 07640135140078. Motor serial numbers between L05333-0001 and L06608-0024
Distribution pattern: Distribution was nationwide. There was government distribution, but no military distribution. Foreign distribution was made to Canada, Chile, Colombia, Costa Rica, Denmark, Dominican Republic, Finland, France, Hong Kong, India, Israel, Italy, Liechtenstein, Mexico, Netherlands, Portugal, Qatar, Romania, Singapore, Slovenia, Spain, Sweden, Switzerland, Taiwan, Thailand, United Arab Emirates, and United Kingdom.
Derived failure modes
-
Unknown
Reports have been received of the CentriMag Systems experiencing motor and pump issues resulting from electromagnetic interference (EMI).