CentriMag Acute Circulatory Support System Motor, U.S. Model 102956 and OUS Model 201-10002, a component of the CentriMag Extracorporeal Blood Pumping System.
This recall has been terminated (originally issued October 30, 2019).
- Recall Initiated
- August 22, 2019
- Posted
- October 30, 2019
- Terminated
- April 26, 2024
- Recall Number
- Z-0221-2020
- Quantity
- 664 units (381 U.S. and 283 OUS)
- Official Source
- View on FDA website ↗
Reason for Recall
Reports have been received of the CentriMag Systems experiencing motor and pump issues resulting from electromagnetic interference (EMI).
Distribution
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.
Lot / Code Info
U.S. Model 102956 UDI: 07640135140078. Motor serial numbers between L05333-0001 and L06608-0024
Root Cause
Process change control
Action Taken
A recall letter dated August 22, 2019 was issued on Abbott letterhead and was delivered by field representative visits beginning August 22, 2019 for the U.S. consignees. Foreign consignees were notified with a letter dated August 22, 2019 containing the same content but OUS model numbers and OUS contact information. Depending on the requirements by the local regulator, the letters may have been delivered by a field representative or via certified mail. The letter identified the affected product, problem and actions to be taken.