Z-0116-06

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

Name: Z-0116-06 QUIK-COMBO pacing/defibrillation/ECG (therapy) cables used with the LIFEPAK 12 defibrillator/monitor series
Creator: Medtronic Emergency Response Systems, Inc.
Published: 2005-09-02
License: https://open.fda.gov/license/

Physio Control, Inc. / initiated 2005-09-02 / Terminated

FDA source

Medtronic Emergency Response Systems, Inc. began a recall of QUIK-COMBO pacing/defibrillation/ECG (therapy) cables used with the LIFEPAK 12 defibrillator/monitor series on 2005-09-02. The reason FDA records is "Potential for voltage pins in connector of therapy cable to break". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0116-06
Status: Terminated
Initiated: 2005-09-02
Posted: 2005-11-02
Terminated: 2011-01-17
Recalling firm: Physio Control, Inc.
Product: QUIK-COMBO pacing/defibrillation/ECG (therapy) cables used with the LIFEPAK 12 defibrillator/monitor series.
Product code: LDD Dc-Defibrillator, Low-Energy, (Including Paddles)
Reason for recall: Potential for voltage pins in connector of therapy cable to break.
FDA root cause: Other
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,
Quantity in commerce: total for both types - 52,654
Distribution: Devices were distributed worldwide.
Product codes and lots: Cables do not contain serial numbers. Therapy cable part number: 3006570-006 and below

Product code LDD

K012274Class IIMedtronic Physio-Control Lifepak 20 Defibrillator/monitor/pacemakerMedtronic Physio-Control Corp. / cleared 2002-02-05

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)