QUIK-STEP 11103Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00883873871577), received between Feb 21, 2023 and Apr 13, 2026 — classified as 3 deaths, 3 malfunctions.

The most frequently reported specific device problem is “Arcing of Electrodes” (2 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 13, 2026Fracture

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THERE IS A BROKEN CLIP ON THE ELECTRODES OF THEIR DEVICE. THIS ISSUE MAY PREVENT THE DEVICE FROM PROVIDING THERAPY IF IT WERE NEEDED.THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24867329 ↗
• MalfunctionFeb 2, 2026Failure to Sense

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE'S ELECTRODES WOULD NOT RECOGNIZE THE PATIENT. 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 24240508 ↗
• MalfunctionOct 29, 2024Device Sensing Problem; Device Sensing Problem

  A CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR ELECTRODES ARE NOT WORKING, THEY ARE NOT RECOGNIZED BY THE DEVICE. IN THIS STATE THE DEVICE MAY NOT BE ABLE TO PROVIDE DEFIBRILLATION THERAPY IF IT WERE NEEDED. THERE WAS NO REPORT OF PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20556190 ↗
• DeathMar 14, 2023Failure to Sense; Failure to Sense

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE WOULD NOT RECOGNIZE THE ELECTRODES WHEN APPLIED TO THE PATIENT. IN THIS STATE THE DEVICE MAY NOT BE ABLE TO DELIVER DEFIBRILLATION THERAPY IF NEEDED. THE ELECTRODES WERE IMMEDIATELY REMOVED AND REPLACED WITH ANOTHER DEVICE'S ELECTRODES. ASYSTOLE WAS DETECTED WITH THE SECOND DEVICE. THE PATIENT ASSOCIATED WITH THE REPORTED EVENT DID NOT SURVIVE. THERE HAS BEEN NO ALLEGED DEVICE CONTRIBUTION TO THE PATIENT OUTCOME.

  Patient problems: Asystole

  MAUDE report 16542050 ↗
• DeathFeb 21, 2023Arcing of Electrodes; Arcing of Electrodes

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THERE WERE ELECTRIC ARCS ON THE ELECTRODES THAT BURNED THE PATIENT AND EMITTED FLAMES. THIS ISSUE HAS THE POTENTIAL TO EITHER DELAY, OR PREVENT, DEFIBRILLATION FROM BEING DELIVERED. THE PATIENT ASSOCIATED WITH THE REPORTED EVENT DID NOT SURVIVE. THE CUSTOMER NOTED THAT USER ERROR IS SUSPECTED IN THIS EVENT.

  Patient problems: Burn(s)

  MAUDE report 16413929 ↗
• DeathFeb 21, 2023Arcing of Electrodes; Arcing of Electrodes

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THERE WERE ELECTRIC ARCS ON THE ELECTRODES THAT BURNED THE PATIENT AND EMITTED FLAMES. THIS ISSUE HAS THE POTENTIAL TO EITHER DELAY, OR PREVENT, DEFIBRILLATION FROM BEING DELIVERED. THE PATIENT ASSOCIATED WITH THE REPORTED EVENT DID NOT SURVIVE. THE CUSTOMER NOTED THAT USER ERROR IS SUSPECTED IN THIS EVENT.

  Patient problems: Burn(s)

  MAUDE report 16411584 ↗

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