Z-0221-2020Class I

CentriMag Acute Circulatory Support System Motor, U.S. Model 102956 and OUS Model 201-10002, a component of...

Name: Z-0221-2020 CentriMag Acute Circulatory Support System Motor, U.S. Model 102956 and OUS Model 201-10002, a component of...
Creator: Thoratec Switzerland GMBH
Published: 2019-08-22
License: https://open.fda.gov/license/

Thoratec Switzerland GmbH / initiated 2019-08-22 / Terminated

FDA source

Thoratec Switzerland GMBH began a recall of CentriMag Acute Circulatory Support System Motor, U.S. Model 102956 and OUS Model 201-10002, a component of the CentriMag Extracorporeal Blood Pumping System on 2019-08-22. FDA classified it as Class I and gives the reason as "Reports have been received of the CentriMag Systems experiencing motor and pump issues resulting from electromagnetic interference (EMI)". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0221-2020
Classification: Class I
Status: Terminated
Initiated: 2019-08-22
Posted: 2019-10-30
Terminated: 2024-04-26
Recalling firm: Thoratec Switzerland GmbH
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.
Product code: KFM Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
Reason for recall: Reports have been received of the CentriMag Systems experiencing motor and pump issues resulting from electromagnetic interference (EMI).
FDA root cause: Process change control
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.
Quantity in commerce: 664 units (381 U.S. and 283 OUS)
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 codes and lots: U.S. Model 102956 UDI: 07640135140078. Motor serial numbers between L05333-0001 and L06608-0024

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0221-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0221-2020	Class I	Terminated	Voluntary: Firm initiated	2019-11-06	2019-10-30

Product code KFM

K020271Class IILevitronix Centrimag Extracorporeal Blood Pumping System, Model L-100Levitronix, LLC / cleared 2003-03-25

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)