CentriMag Acute Circulatory Support System Motor, U.S.… recallZ-0221-2020 · Thoratec Switzerland GMBH · initiated Aug 22, 2019
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Thoratec Switzerland GMBH or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Reports have been received of the CentriMag Systems experiencing motor and pump issues resulting from electromagnetic interference (EMI).
FDA root cause category: Process change control
What the company is doing
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.
Recall details
- Recall number
- Z-0221-2020
- Status
- Terminated
- Initiated by the company
- Aug 22, 2019
- Posted by the FDA
- Oct 30, 2019
- Recalling firm
- Thoratec Switzerland GMBH
- Quantity
- 664 units (381 U.S. and 283 OUS)
- Product code
- KFM
- FDA submissions
- K020271
- 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.
Product description
CentriMag Acute Circulatory Support System Motor, U.S. Model 102956 and OUS Model 201-10002, a component of the CentriMag Extracorporeal Blood Pumping System.
Code information (models, lots, serial numbers)
U.S. Model 102956 UDI: 07640135140078. Motor serial numbers between L05333-0001 and L06608-0024
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- CENTRIMAG MOTOR 102956Thoratec Switzerland GmbH · Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type2 recalls4 deaths591 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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