CentriMag Acute Circulatory Support System Motor, U.S. Model 102956 and OUS Model 201-10002, a component of the CentriMag Extracorporeal Blood Pumping System.
FDA Recall Z-0221-2020 · Posted 2019-10-30
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Recalling FirmThoratec Switzerland GMBH
Recall StatusTerminated
Product CodeKFM
Date Initiated2019-08-22
Date Terminated2024-04-26
Product Quantity664 units (381 U.S. and 283 OUS)
Reason for Recall
Reports have been received of the CentriMag Systems experiencing motor and pump issues resulting from electromagnetic interference (EMI).
Firm Action
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.
Root Cause
Process change control
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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