LIFEPAK 35 Monitor/Defibrillator 99335 (REF 99335-000029)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00883873765661), received between Sep 22, 2025 and Sep 22, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Failure to Charge” (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.

• MalfunctionSep 22, 2025Failure to Charge; Unexpected Shutdown; Failure to Charge; Unexpected Shutdown

  A CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE POWER CYCLED UNEXPECTEDLY AND THE CHARGE BUTTON WOULD NOT WORK. AS A RESULT, DEFIBRILLATION THERAPY WOULD NOT BE AVAILABLE, IF NEEDED. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23118358 ↗

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-0299-2024 · Sep 29, 2023 · Open, Classified
  LIFEPAK 15, REF: 99577-001255, Part Number V15-2-001602
• Z-0297-2024 · Sep 29, 2023 · Open, Classified
  LIFEPAK 15, REF: 99577-000055, Part Number V15-2-000061
• Z-0298-2024 · Sep 29, 2023 · Open, Classified
  LIFEPAK 15, REF: 99577-000061, Part Number V15-2-000067
• Z-0303-2024 · Sep 29, 2023 · Open, Classified
  LIFEPAK 15, REF: 99577-001957, Part Number V15-5-000586 and V15-7-000022
• Z-0305-2024 · Sep 29, 2023 · Open, Classified
  LIFEPAK 15, REF: 99577-001960, Part Number: V15-7-000026
• Z-0301-2024 · Sep 29, 2023 · Open, Classified
  LIFEPAK 15, REF: 99577-001955, Part Number V15-5-000584 and V15-7-000020
• Z-0296-2024 · Sep 29, 2023 · Open, Classified
  LIFEPAK 15, REF: 99577-000046, Part Number V15-2-000051
• Z-0300-2024 · Sep 29, 2023 · Open, Classified
  LIFEPAK 15, REF: 99577-001373, Part Number V15-7-000002

…and 2 more.