Recall Z-1607-2013— Medtronic Inc. Cardiac Rhythm Disease Management
Class II · Terminated
Class II FDA medical device recall by Medtronic Inc. Cardiac Rhythm Disease Management, initiated 2013-06-07, terminated 2014-03-07. FDA's recall record names no specific 510(k) clearance for this event. Product: Medtronic, Consulta¿ CRT-P, Model C4TR01, C3TR01 (not approved for US), and Syncra¿ CRT-P, Model C2TR01, Sterile EO. Dual chamber and atrial tracking modes are indicated for patients who may benefit from maintenance of AV synchrony.. Reason: Medtronic recently identified an issue with a subset of Consulta¿ CRT-P and Syncra¿ CRT-P devices during production. As of May 30, 2013, there have been no reported or confirmed device failures. However, because of the potential for malfunction, Medtronic is requiring the return of non-implanted devices manufactured between April 1 and May 13, 2013 for re-inspection. The issue is unique to specifi.
- Recalling firm
- Medtronic Inc. Cardiac Rhythm Disease Management
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-06-07
- Terminated
- 2014-03-07
- Firm location
- Saint Paul, MN, United States
Product description
Medtronic, Consulta¿ CRT-P, Model C4TR01, C3TR01 (not approved for US), and Syncra¿ CRT-P, Model C2TR01, Sterile EO. Dual chamber and atrial tracking modes are indicated for patients who may benefit from maintenance of AV synchrony.
Reason for recall
Medtronic recently identified an issue with a subset of Consulta¿ CRT-P and Syncra¿ CRT-P devices during production. As of May 30, 2013, there have been no reported or confirmed device failures. However, because of the potential for malfunction, Medtronic is requiring the return of non-implanted devices manufactured between April 1 and May 13, 2013 for re-inspection. The issue is unique to specifi
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