RecallRadar

FDA Device recall Z-0221-2020

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

On 2019-11-06 the FDA classified a Class I recall of CentriMag Acute Circulatory Support System Motor, U.S. Model 102956 and OUS Model 201-10002, a component of the CentriMag Extracorporeal Bl… by Thoratec Switzerland, citing reports have been received of the CentriMag Systems experiencing motor and pump issues resulting from electromagnetic interference (EMI).

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0221-2020
ClassificationClass I
Statusterminated
Initiated2019-08-22
Published2019-11-06
Last updated2026-09-13 11:55 UTC
CompanyThoratec Switzerland
DistributionUS

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.

Reason

Reports have been received of the CentriMag Systems experiencing motor and pump issues resulting from electromagnetic interference (EMI).

Identifiers

code_infoU.S. Model 102956 UDI: 07640135140078. Motor serial numbers between L05333-0001 and L06608-0024

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0221-2020%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.