LIFEPAK 15 monitor/defibrillator 97577 (REF 97577-000103)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00883873808191), received between Dec 30, 2021 and Dec 30, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Unexpected Shutdown” (1 report).

17 other recalls cover devices cleared under the same FDA submission (P160026); 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 30, 2021Unexpected Shutdown; Unexpected Shutdown

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE UNEXPECTEDLY SHUT OFF. 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 13122347 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P160026. One submission often covers many models, so check the product and lot details in each record.

• Z-2065-2026 · Apr 13, 2026 · Open, Classified
  LIFEPAK 15, REF: 99577-000025, 99577-000047, 99577-001256, 99577-001217, 99577-001241, 99577-001255, 99577-001219, 99577-001957, 99577-001935, 99577-001964, 99577-001955, 99577-001
• Z-2497-2025 · Jul 22, 2025 · Open, Classified
  LIFEPAK 15 Part / Catalog Numbers / UDI-DI code: V15-7-000022 / 99577-001957 / 883873871690 V15-2-000051 / 99577-000046 / 883873988022 V15-2-000099 / 99577-000093 / 883873979020 V
• Z-2498-2025 · Jul 22, 2025 · Open, Classified
  LIFEPAK 1000 Part / Catalog Numbers / UDI-DI code: 320371500023 / 99425-000025 / 885074698953 320371500229 / 99425-000025 / 885074698953 331706400001 / 99425-000025 / 885074698953
• Z-1232-2025 · Feb 3, 2025 · Open, Classified
  LIFEPAK 20e REF 99507-000001 The AED mode is to be used only on patients in cardiopulmonary arrest.
• Z-1184-2025 · Jan 21, 2025 · Open, Classified
  LIFEPAK 15 V4/Masimo Rainbow Sensors: Masimo RD rainbow Adt 8 SpCO, SpO2, and SpMet, Adult Adhesive Sensors REF 11996-000515 Masimo LNCS-II rainbow DCI 8 SpCO, Adult Reusable Sen
• Z-0230-2025 · Aug 30, 2024 · Open, Classified
  LIFEPAK 15 (LP15) Model/Catalog Numbers: o 97577-000101 o 99577-000046 o 99577-000055 o 99577-000061 o 99577-000076 o 99577-001250 o 99577-001255 o 99577-001256 o 99577-001368 o 99
• Z-0567-2024 · Nov 6, 2023 · Open, Classified
  AC Power Adapter for use with the LIFEPAK 15 Monitor/Defibrillator, REF: 11140-000098
• Z-0296-2024 · Sep 29, 2023 · Open, Classified
  LIFEPAK 15, REF: 99577-000046, Part Number V15-2-000051
• Z-0301-2024 · Sep 29, 2023 · Open, Classified
  LIFEPAK 15, REF: 99577-001955, Part Number V15-5-000584 and V15-7-000020
• Z-0305-2024 · Sep 29, 2023 · Open, Classified
  LIFEPAK 15, REF: 99577-001960, Part Number: V15-7-000026
• Z-0302-2024 · Sep 29, 2023 · Open, Classified
  LIFEPAK 15, REF: 99577-001956, Part Number V15-7-000021
• Z-0304-2024 · Sep 29, 2023 · Open, Classified
  LIFEPAK 15, REF: 99577-001958, Part Number: V15-7-000023
• Z-0297-2024 · Sep 29, 2023 · Open, Classified
  LIFEPAK 15, REF: 99577-000055, Part Number V15-2-000061
• Z-0303-2024 · Sep 29, 2023 · Open, Classified
  LIFEPAK 15, REF: 99577-001957, Part Number V15-5-000586 and V15-7-000022
• Z-0300-2024 · Sep 29, 2023 · Open, Classified
  LIFEPAK 15, REF: 99577-001373, Part Number V15-7-000002

…and 2 more.