Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1607-2013 — 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.

U.S. FDA — Device Enforcement · United States · 2013-06-07 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1607-2013
Date of alert
2013-06-07
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Medtronic Inc. Cardiac Rhythm Disease Management
Product category
device
Product type
Devices
Reported risk: 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
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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