Recall Z-0103-2019— Thoratec Switzerland GMBH
Class II · Terminated
Class II FDA medical device recall by Thoratec Switzerland GMBH, initiated 2018-09-05, terminated 2021-04-28. It names 5 FDA 510(k) clearances: K131179, K090051, K090004 and 2 more. Product: Thoratec CentriMag Motor, Model: 102956, a component of the Thoratec CentriMag Blood Pumping System and PediMag Blood Pumping System.. Reason: Reports of circulatory support system motor stopping. Motor stop can be attributed to a break of a wire or short circuit between wires within the electrical cable where the cable exits the motor cable bend protection..
- Recalling firm
- Thoratec Switzerland GMBH
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-09-05
- Terminated
- 2021-04-28
- Firm location
- Zurich, N/A, Switzerland
510(k) clearances named in this recall
5 on FDA's record- K131179 — CENTRIMAG PRIMARY CONSOLE (2ND GENERATION); MAG MONITOR
- K090051 — LEVITRONIX PEDIMAG BLOOD PUMP, MODEL 201-90052
- K090004 — LEVITRONIX, THORATEC CENTRIMAG BACK-UP CONSOLES
- K083340 — LEVITRONIX CENTRIMAG PRIMARY CONSOLE; THORATEC CANTRIMAG PRIMARY CONSOLE
- K020271 — LEVITRONIX CENTRIMAG EXTRACORPOREAL BLOOD PUMPING SYSTEM, MODEL L-100
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Thoratec CentriMag Motor, Model: 102956, a component of the Thoratec CentriMag Blood Pumping System and PediMag Blood Pumping System.
Reason for recall
Reports of circulatory support system motor stopping. Motor stop can be attributed to a break of a wire or short circuit between wires within the electrical cable where the cable exits the motor cable bend protection.
Data sourced from openFDA. This site is unofficial and independent of the FDA.