LIFEPAK CR Plus and LIFEPAK Express defibrillators 99403 (REF 99403-000002)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00883873820247), received between Jan 7, 2019 and May 23, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Power Problem” (2 reports).

1 other recall cover devices cleared under the same FDA submission (P160012); 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 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 23, 2025Power Problem; Power Problem

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE DISPLAYED ALL THREE ICONS (CHARGE-PAK, ATTENTION, AND SERVICE WRENCH). THE ILLUMINATION OF ALL THREE ICONS INDICATES THAT THE DEVICE MAY NOT BE ABLE TO PROVIDE SUFFICIENT DEFIBRILLATION THERAPY, IF NECESSARY. THERE WAS NO PATIENT USE ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22077132 ↗
• MalfunctionJun 9, 2022Failure to Power Up; Failure to Power Up

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE WAS NOT TURNING ON. IN THIS STATE THE DEVICE WOULD BE INOPERABLE AND DEFIBRILLATION THERAPY MAY NOT BE AVAILABLE IF NEEDED. THERE WAS NO PATIENT INVOLVEMENT REPORTED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14645103 ↗
• MalfunctionJan 7, 2019Power Problem; Power Problem

  A CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE WAS SHOWING ALL THREE ICONS (ATTENTION, CHARGE-PAK AND SERVICE WRENCH). WITH ALL THREE ICONS ILLUMINATED, THE DEVICE MAY NOT HAVE SUFFICIENT POWER AVAILABLE TO DELIVER EFFECTIVE DEFIBRILLATION THERAPY TO A PATIENT, IF IT WAS NEEDED. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 8223915 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P160012. One submission often covers many models, so check the product and lot details in each record.

• Z-1544-2026 · Jan 21, 2026 · Open, Classified
  PHYSIO CONTROL INFANT/CHILD Reduced Energy Defibrillator Electrodes Catalog Numbers: 11101-000016 UDI-DI code: 00721902629013 Catalog Number: 11101-000017 UDI-DI code: 00721902682