NA 11101Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00883873867808), received between Feb 7, 2023 and Sep 16, 2026 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Device Sensing Problem” (4 reports).

2 other recalls cover devices cleared under the same FDA submission (P170018); they may or may not involve this specific model.

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 16, 2026Device Sensing Problem

  The customer contacted Stryker to report that during a patient event the defibrillation electrodes on their device would not adhere properly to the patient and did not function with the device. Another set of electrodes were used. As a result defibrillation therapy may be delayed or would not be available if needed.This issue is patient related; however there was no adverse patient outcome reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50791656 ↗
• MalfunctionJul 7, 2026Connection Problem

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE'S ELECTRODE IS NOT RECOGNIZED BY ANY OF THEIR DEVICES. 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 25730116 ↗
• MalfunctionApr 11, 2026Electrical /Electronic Property Problem; Device Sensing Problem

  A CUSTOMER CONTACTED STRYKER TO REPORT THAT THE ELECTRODES CONNECTED TO THEIR DEVICE WERE NOT BEING RECOGNIZED. ANOTHER SET OF ELECTRODES WERE AVAILABLE AND WERE USED; THE DEVICE RECOGNIZED THEM AND CONNECTED CORRECTLY. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24852354 ↗
• MalfunctionFeb 25, 2026Fracture

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEFIBRILLATION PADS WERE BROKEN. 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 24442838 ↗
• MalfunctionNov 19, 2025Device Sensing Problem; Device Sensing Problem

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR ELECTRODES WERE NOT WORKING. IN THIS STATE THE DEVICE MAY NOT BE ABLE TO DELIVER DEFIBRILLATION THERAPY, IF NEEDED. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23591258 ↗
• MalfunctionJun 12, 2025Device Sensing Problem; Device Sensing Problem

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR ELECTRODES WERE NOT WORKING WITH THE DEVICE. 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 22191854 ↗
• MalfunctionMay 29, 2024Connection Problem; Connection Problem

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR ELECTRODES WERE NOT RECOGNIZED BY ANY OF THEIR DEVICES. AS A RESULT, DEFIBRILLATION THERAPY MAY HAVE BEEN DELAYED OR UNAVAILABLE, IF NEEDED. THERE WAS NO REPORT OF PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19416347 ↗
• MalfunctionJan 31, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE'S ELECTRODE'S DID NOT DEPLOY AS EXPECTED AND COULD NOT BE USED TO DEFIBRILLATE A PATIENT. ANOTHER AED WAS USED AFTER A DELAY. THE PATIENT INVOLVED IN THE EVENT DID NOT SURVIVE. IT IS NOT KNOWN IF THIS EVENT CAUSED OR CONTRIBUTED TO THEIR DEATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18615768 ↗
• MalfunctionAug 2, 2023Failure to Sense; Failure to Sense

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE WOULD NOT DETECT THE ELECTRODES. THIS ISSUE HAS THE POTENTIAL TO EITHER DELAY, OR PREVENT, DEFIBRILLATION FROM BEING DELIVERED. THERE WAS NO REPORT OF PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17445830 ↗
• MalfunctionJul 27, 2023Electrical /Electronic Property Problem; Failure to Sense; Electrical /Electronic Property Problem; Failure to Sense

  A CUSTOMER CONTACTED STRYKER TO REPORT THAT THE DEVICE WOULD NOT DETECT THE ELECTRODES BEING CONNECTED. AS A RESULT, DEFIBRILLATION THERAPY WOULD NOT BE AVAILABLE, IF NEEDED. THERE WERE NO REPORTS OF PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17403530 ↗
• MalfunctionFeb 7, 2023Mechanical Problem; Mechanical Problem

  A CUSTOMER CONTACTED STRYKER TO REPORT THAT SEAL ON THEIR ELECTRODES WAS BROKEN UP. THIS ISSUE HAS THE POTENTIAL TO EITHER DELAY, OR PREVENT, DEFIBRILLATION FROM BEING DELIVERED.  THERE WAS NO PATIENT INVOLVED IN THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16311416 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P170018. One submission often covers many models, so check the product and lot details in each record.

• Z-2499-2025 · Jul 22, 2025 · Open, Classified
  LIFEPAK CR2 Part / Catalog Numbers / UDI-DI code: CR2-2-001451 99512-001434 883873785911 LIFEPAK CR2: The LIFEPAK CR2 defibrillator is indicated for use on patients 1 year of age
• Z-1189-2021 · Jan 14, 2021 · Open, Classified
  PHYSIO CONTROL LIFEPAK CR2 Defibrillator 3321605-xxx The LIFEPAK CR2 defibrillator is designed for indoor and outdoor use in a stationary environment. After the electrode pads