NA 11131 (REF 11131-000045)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
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00883873863497), received between Sep 3, 2024 and Jun 30, 2026 — classified as 6 malfunctions.
The most frequently reported specific device problem is “Failure to Deliver Shock/Stimulation” (5 reports).
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/Stimulation5
- Fracture1
- Inappropriate/Inadequate Shock/Stimulation1
Patient problems
- No Clinical Signs, Symptoms or Conditions5
- Cardiac Arrest1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 30, 2026Inappropriate/Inadequate Shock/Stimulation
THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE'S INTERNAL PADDLES FAILED THE CONTINUITY TEST. IN THIS STATE THE PADDLES MAY NOT BE ABLE TO DELIVER THE APPROPRIATE DEFIBRILLATION THERAPY IF NEEDED. THERE WAS NO PATIENT INVOLVEMENT REPORTED WITH THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25665569 ↗MalfunctionMay 27, 2026Failure to Deliver Shock/Stimulation; Fracture
THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE'S INTERNAL PADDLES DID NOT DELIVER A SHOCK. A 2ND SET WAS USED TO DELIVER THE SHOCK. IN THIS STATE THE DEVICE MAY NOT BE ABLE TO DELIVER DEFIBRILLATION THERAPY IF NEEDED THIS ISSUE IS PATIENT RELATED; HOWEVER THERE WAS NO ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25298632 ↗MalfunctionOct 22, 2025Failure to Deliver Shock/Stimulation; Failure to Deliver Shock/Stimulation
A CUSTOMER CONTACTED STRYKER TO REPORT THAT THE INTERNAL PADDLES OF THEIR DEVICE DID NOT WORK. AS A RESULT, DEFIBRILLATION THERAPY WOULD NOT HAVE BEEN AVAILABLE, IF NEEDED. THERE WERE NO REPORTS OF HARM TO THE PATIENT AS A RESULT OF THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23356177 ↗MalfunctionJan 2, 2025Failure to Deliver Shock/Stimulation; Failure to Deliver Shock/Stimulation
THE CUSTOMER CONTACTED STRYKER TO REPORT DELAY IN THE DELIVERY OF THE SHOCK DURING INTERVENTION ON A PATIENT. IN THIS STATE THE DEVICE MAY NOT BE ABLE TO PROVIDE DEFIBRILLATION THERAPY IF IT WERE NEEDED. THE PATIENT ASSOCIATED WITH THE REPORTED EVENT DID NOT SURVIVE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21060343 ↗MalfunctionSep 3, 2024Failure to Deliver Shock/Stimulation; Failure to Deliver Shock/Stimulation
THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE INTERNAL PADDLES HAVE FAILED. IN THIS STATE THE DEVICE MAY NOT BE ABLE TO DELIVER DEFIBRILLATION THERAPY IF NEEDED. THERE WAS NO PATIENT INVOLVEMENT REPORTED WITH THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20131295 ↗MalfunctionSep 3, 2024Failure to Deliver Shock/Stimulation; Failure to Deliver Shock/Stimulation
THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE PADDLES DID NOT DELIVER ENERGY WHEN THE SHOCK BUTTON WAS PUSHED. IN THIS STATE THE DEVICE MAY NOT BE ABLE TO DELIVER DEFIBRILLATION THERAPY IF NEEDED. THIS ISSUE IS PATIENT RELATED; HOWEVER THERE WAS NO ADVERSE EVENT REPORTED.
Patient problems: Cardiac Arrest
MAUDE report 20126502 ↗
Other Dc-defibrillator, low-energy, (including paddles) devices
- NA 11131Physio-Control, Inc. · Dc-defibrillator, low-energy, (including paddles)1 recall5 reports
- NA 11131Physio-Control, Inc. · Dc-defibrillator, low-energy, (including paddles)1 recall1 report
- 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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