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Terminated

QUIK-COMBO pacing/defibrillation/ECG (therapy) cables used with the LIFEPAK 12 defibrillator/monitor series.

FDA Recall Z-0116-06 · Posted 2005-11-02

Recalling FirmMedtronic Emergency Response Systems, Inc.
Recall StatusTerminated
Product CodeLDD
Date Initiated2005-09-02
Date Terminated2011-01-17
Product Quantitytotal for both types - 52,654

Reason for Recall

Potential for voltage pins in connector of therapy cable to break.

Firm Action

On 9/2/05 the firm issued letters dated September 2005 to their customers. The letters state the problem, advise the cables and/or connectors will be replaced, and emphasize daily inspection and testing,

Root Cause

Other

Distribution Pattern

Devices were distributed worldwide.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K012274MEDTRONIC PHYSIO-CONTROL LIFEPAK 20 DEFIBRILLATOR/MONITOR/PACEMAKERMedtronic Physio-Control Corp. · 2002-02-05

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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