NA 11131 (REF 11131-000047)Recalls & reported problems
Physio-Control, Inc. · Sterilizable Internal Defibrillation Paddles, LP15 · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00883873863213), received between Jun 30, 2026 and Jun 30, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Failure to Deliver Shock/Stimulation” (1 report).
1 FDA recall record name this device's identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Recalls naming this device
- Aug 9, 2024Open, Classified
Due to customer complaints and out of box failures, the firm is conducting a voluntary recall as a result of product failures (cracks and over-molding separation of the sterilizable internal defibrillation paddles.
Z-0142-2025 · Root cause: Under Investigation by firm · FDA record ↗
Most reported problems
Device problems
- Failure to Deliver Shock/Stimulation1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 30, 2026Failure to Deliver Shock/Stimulation
THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE'S INTERNAL PADDLES DID NOT SEND A SHOCK TO A PATIENT. THIS ISSUE IS PATIENT RELATED; HOWEVER THERE WAS NO ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25665570 ↗
Other Dc-defibrillator, low-energy, (including paddles) devices
- NA 11131Physio-Control, Inc. · Dc-defibrillator, low-energy, (including paddles)1 recall6 reports
- NA 11131Physio-Control, Inc. · Dc-defibrillator, low-energy, (including paddles)1 recall5 reports
- NA 11131Physio-Control, Inc. · Dc-defibrillator, low-energy, (including paddles)1 recall0 reports
- NA 11131Physio-Control, Inc. · Dc-defibrillator, low-energy, (including paddles)1 recall0 reports
- NA 11131Physio-Control, Inc. · Dc-defibrillator, low-energy, (including paddles)1 recall0 reports
- NA 11131Physio-Control, Inc. · Dc-defibrillator, low-energy, (including paddles)1 recall0 reports
- NA 11131Physio-Control, Inc. · Dc-defibrillator, low-energy, (including paddles)1 recall0 reports
- Internal Handle 1011-0139-05Zoll Medical Corporation · Dc-defibrillator, low-energy, (including paddles)17 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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