LIFEPAK 20 and LIFEPAK 20e defibrillator/monitors 99402 (REF 99402-000067)Recalls & reported problems

Summary

The FDA's MAUDE database contains 38 adverse event reports that list this exact device (DI 00883873813782), received between Dec 17, 2018 and Aug 27, 2024 — classified as 38 malfunctions.

The most frequently reported specific device problem is “Inappropriate/Inadequate Shock/Stimulation” (7 reports).

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 25 most recent of 38 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 27, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE CUSTOMER CONTACTED STRYKER TO REPORT THEIR DEVICE WAS BOOTING UP TO A BLANK DISPLAY. THIS CAN BE INDICATIVE OF A DEVICE LOCK UP CONDITION. AS A RESULT, DEFIBRILLATION THERAPY MAY BE UNAVAILABLE, IF IT WAS NEEDED. THERE WAS NO PATIENT INVOLVEMENT REPORTED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20074800 ↗
• MalfunctionApr 22, 2022Inappropriate/Inadequate Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE DID NOT DELIVER ENOUGH ENERGY DURING A CASE. 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14182110 ↗
• MalfunctionJun 28, 2021Device Sensing Problem; Device Sensing Problem

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT DURING A PATIENT EVENT THEIR DEVICE PROMPTED, "CONNECT ELECTRODES". THE CUSTOMER ADVISED THIS OCCURRED WHEN ATTEMPTING TO SHOCK A PATIENT DURING A CARDIOVERSION PROCEDURE. IN THIS STATE DEFIBRILLATION THERAPY WOULD NOT BE AVAILABLE TO A PATIENT IF NEEDED. THE CUSTOMER ADVISED THAT THE DEFIBRILLATION ELECTRODES WERE REPLACED AND THE PROCEDURE WAS COMPLETED. THERE WAS NO ADVERSE PATIENT OUTCOME REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12073235 ↗
• MalfunctionJun 28, 2021Device Sensing Problem; Device Sensing Problem

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT DURING A PATIENT EVENT THEIR DEVICE PROMPTED, "CONNECT ELECTRODES". THE CUSTOMER ADVISED THIS OCCURRED WHEN ATTEMPTING TO SHOCK A PATIENT DURING A CARDIOVERSION PROCEDURE. IN THIS STATE DEFIBRILLATION THERAPY WOULD NOT BE AVAILABLE TO A PATIENT IF NEEDED. THE CUSTOMER ADVISED THAT THE DEFIBRILLATION ELECTRODES WERE REPLACED AND THE PROCEDURE WAS COMPLETED. THERE WAS NO ADVERSE PATIENT OUTCOME REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12073217 ↗
• MalfunctionMay 7, 2021Defibrillation/Stimulation Problem; Defibrillation/Stimulation Problem

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE DISPLAYED ¿ABNORMAL ENERGY DELIVERY¿ WHEN TESTING AND THE SERVICE INDICATOR WAS ILLUMINATED. IN THIS STATE, WRONG DEFIBRILLATION THERAPY MAY BE DELIVERED TO THE PATIENT. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11790224 ↗
• MalfunctionMar 16, 2021Delayed Charge Time; Delayed Charge Time

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE WAS CHARGING LONGER THAN USUAL TO CHARGE DEFIBRILLATION ENERGY. AS A RESULT, DEFIBRILLATION THERAPY MAY BE DELAYED, IF NEEDED. THERE WAS NO REPORT OF PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11496028 ↗
• MalfunctionFeb 23, 2021Failure to Power Up; Failure to Power Up

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE WOULD NOT POWER ON WITH EITHER AC OR DC POWER. THERE WAS NO PATIENT INVOLVEMENT REPORTED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11363772 ↗
• MalfunctionNov 9, 2020Failure to Sense; Failure to Sense

  THE CUSTOMER REPORTED VIA A VOLUNTARY MEDWATCH REPORT THAT THEY WERE USING THEIR DEVICE TO ATTEMPT TO DELIVER DEFIBRILLATION TO A PATIENT AND THE DEVICE DID NOT SHOW THE PATIENT'S ECG RHYTHM. AS A RESULT, DEFIBRILLATION THERAPY MAY HAVE BEEN UNAVAILABLE, IF NEEDED. THERE WERE NO REPORTS OF ANY ADVERSE EFFECTS TO THE PATIENT AS A RESULT OF THE REPORTED ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10810192 ↗
• MalfunctionJul 23, 2020Failure to Power Up; Failure to Power Up

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE'S ON/OFF BUTTON IS NOT RESPONSIVE. IT REQUIRES A LARGE AMOUNT OF FORCE TO ACTIVATE AND SOMETIMES IT STILL DOESN'T TURN THE DEVICE ON. AS A RESULT, DEFIBRILLATION THERAPY MAY BE 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; No Patient Involvement

  MAUDE report 10315134 ↗
• MalfunctionJul 22, 2020Failure to Power Up; Failure to Power Up

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE WOULD INTERMITTENTLY NOT POWER ON. AS A RESULT, DEFIBRILLATION THERAPY MAY BE DELAYED OR WOULD NOT BE AVAILABLE IF NEEDED. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 10310817 ↗
• MalfunctionJul 9, 2020Energy Output Problem; Energy Output Problem

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT A NON-CRITICAL ISSUE WITH THEIR DEVICE. THERE WAS NO REPORT OF PATIENT USE ASSOCIATED WITH THE REPORTED EVENT. UPON EVALUATION OF THE CUSTOMER'S DEVICE, PHYSIO-CONTROL OBSERVED THAT THE DEVICE WAS DELIVERING MONOPHASIC ENERGY RATHER THAN BIPHASIC ENERGY. AS A RESULT, THE WRONG DEFIBRILLATION THERAPY MAY BE DELIVERED TO A PATIENT, IF NEEDED.

  Patient problems: No Patient Involvement

  MAUDE report 10253568 ↗
• MalfunctionJun 29, 2020Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE IS NOT COMPLETING THE BOOT UP PROCESS. AS A RESULT, DEFIBRILLATION THERAPY MAY BE UNAVAILABLE, IF NEEDED. THERE WAS NO REPORT OF PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 10209701 ↗
• MalfunctionJun 18, 2020Defibrillation/Stimulation Problem; Defibrillation/Stimulation Problem

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE HAD A NON-CRITICAL ISSUE. UPON PHYSIO-CONTROL EVALUATION THE DEVICE WAS OBSERVED TO FAIL TO DELIVER APPROPRIATE SHOCK. THE DEVICE PROVIDED AN ABNORMAL ENERGY DELIVER MESSAGE AND IS NOT PASSING THE SELF-TEST. A PARTIAL LOSS OF DEFIBRILLATOR OUTPUT ENERGY DUE TO A LOSS OF THE NEGATIVE OR POSITIVE PORTION OF THE BIPHASIC OUTPUT WAVEFORM WAS OBSERVED AND THE DEFIBRILLATOR OUTPUT ENERGY WAS REDUCED FROM THE SELECTED ENERGY LEVEL. THERE WAS NO PATIENT USE REPORTED WITH THE EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 10168825 ↗
• MalfunctionApr 19, 2020Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THE DEVICE WAS BOOTING UP WITH A COMPLETELY WHITE DISPLAY. A WHITE DISPLAY CAN BE INDICATIVE OF A DEVICE LOCK UP CONDITION. AS A RESULT DEFIBRILLATION THERAPY MAY BE UNAVAILABLE, IF IT IS NEEDED. THERE WAS NO PATIENT INVOLVEMENT IN THIS EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 9975809 ↗
• MalfunctionMar 26, 2020Inappropriate/Inadequate Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE SERVICE INDICATOR WAS ILLUMINATED. UPON EVALUATION OF THE CUSTOMER'S DEVICE, PHYSIO-CONTROL OBSERVED THAT THE DEVICE WAS DELIVERING A MONOPHASIC ENERGY OUTPUT INSTEAD OF A BIPHASIC OUTPUT. AS A RESULT, THE INCORRECT DEFIBRILLATION THERAPY MAY BE DELIVERED. THERE WAS NO PATIENT USE ASSOCIATED WITH THIS EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 9883243 ↗
• MalfunctionMar 25, 2020Inappropriate/Inadequate Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE IS NOT PASSING THE SELF-TEST. THERE WAS NO PATIENT USE REPORTED WITH THE EVENT. UPON EVALUATION, PHYSIO OBSERVED THAT THE DEVICE LOGGED A CRITICAL EVENT CODE. THE EVENT CODE IS INDICATIVE OF A DEVICE ISSUE THAT COULD RESULT IN A PARTIAL LOSS OF DEFIBRILLATOR OUTPUT ENERGY DUE TO A LOSS OF THE NEGATIVE OR POSITIVE PORTION OF THE BIPHASIC OUTPUT WAVEFORM. THE DEFIBRILLATOR OUTPUT ENERGY COULD BE REDUCED BY UP TO APPROXIMATELY 20% FROM THE SELECTED ENERGY LEVEL. ADDITIONALLY, PHYSIO OBSERVED MONOPHASIC SHOCK DELIVERED INSTEAD OF BIPHASIC SHOCK.

  Patient problems: No Patient Involvement

  MAUDE report 9881356 ↗
• MalfunctionFeb 26, 2020Failure to Power Up; Failure to Power Up

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE WOULD NOT POWER ON. THERE WAS NO REPORT OF PATIENT USE FOR THE REPORTED EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 9758240 ↗
• MalfunctionFeb 12, 2020Failure to Sense; Failure to Sense

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE FAILED TO RECOGNIZE THE PATIENT'S ECG DURING A CARDIOVERSION EVENT. THE HEALTHCARE PROVIDERS USED ANOTHER LIFEPAK 20E TO PROVIDE THERAPY TO THE PATIENT, AND THE PATIENT WAS SUCCESSFULLY CONVERTED. THIS ISSUE IS PATIENT RELATED; HOWEVER THERE WAS NO ADVERSE PATIENT OUTCOME REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9702556 ↗
• MalfunctionJan 2, 2020Failure to Sense; Failure to Sense

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE WOULD NOT RECOGNIZE PADDLES. IN THIS STATE THE DEVICE WOULD NOT BE ABLE TO DELIVER DEFIBRILLATION THERAPY IF NEEDED. THERE WAS NO PATIENT USE REPORTED WITH THE EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 9541239 ↗
• MalfunctionSep 13, 2019Device Sensing Problem; Device Sensing Problem

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT DURING A PATIENT EVENT THEIR DEVICE WAS UNABLE TO DETECT THE PATIENT THROUGH THE DEFIBRILLATION THERAPY CABLE. IN THIS STATE, THE DEVICE WOULD BE INOPERABLE AND DEFIBRILLATION THERAPY WOULD NOT BE AVAILABLE IF NEEDED. THE CUSTOMER ADVISED THAT THEY WERE ABLE TO USE THE DEVICE WITH THE DEFIBRILLATION HARD PADDLES. THIS ISSUE IS PATIENT RELATED; HOWEVER THE CUSTOMER ADVISED THAT THERE WAS NO ADVERSE PATIENT OUTCOME DUE TO THE DEVICE USE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9041292 ↗
• MalfunctionSep 3, 2019Failure to Sense; Failure to Sense

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE FAILED TO SENSE ECG VIA DEFIBRILLATION THERAPY ELECTRODES. THE CUSTOMER INITIALLY INDICATED THERE WAS NO IMPACT AS A BACKUP DEVICE WAS READILY AVAILABLE. PHYSIO-CONTROL CONTACTED THE CUSTOMER TO REQUEST ADDITIONAL INFORMATION ON THE PATIENT. NO RESPONSE HAS BEEN RECEIVED FROM THE CUSTOMER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8957645 ↗
• MalfunctionAug 15, 2019Connection Problem; Connection Problem

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT A PIN IN THEIR DEVICE'S THERAPY CONNECTOR IS DAMAGED AND APPEARS TO BE BROKEN. AS A RESULT, DEFIBRILLATION THERAPY MAY BE DELAYED OR UNAVAILABLE, IF IT WAS NEEDED. THERE WAS NO REPORT OF PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 8896381 ↗
• MalfunctionJul 15, 2019Failure to Deliver Energy; Failure to Deliver Energy

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT DURING TESTING OF THEIR DEVICE THEY HEARD A "POP" SOUND AND SMELLED SMOKE. UPON EVALUATION OF THE CUSTOMER¿S DEVICE, PHYSIO-CONTROL OBSERVED THAT THE DEVICE WAS UNABLE TO DELIVER DEFIBRILLATION ENERGY AND DISPLAYED AN ¿ABNORMAL ENERGY DELIVERY¿ MESSAGE. THE DEVICE SHOCKED BUT THERE WAS NO ENERGY OUTPUT. THERE WAS NO PATIENT USE ASSOCIATED WITH THIS EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 8791780 ↗
• MalfunctionJul 2, 2019Unexpected Shutdown; Unexpected Shutdown

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT A NON-CRITICAL ISSUE WITH THEIR DEVICE. UPON EVALUATION OF THE CUSTOMER¿S DEVICE, PHYSIO-CONTROL OBSERVED THAT THE DEVICE COULD ONLY BE CHARGED TO 10 JOULES FOR DEFIBRILLATION. ANY ENERGY LEVEL HIGHER THAN 10 JOULES WOULD RESULT IN THE DEVICE POWERING ITSELF OFF WHEN THE CHARGE BUTTON WAS PRESSED. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 8756292 ↗
• MalfunctionJun 25, 2019Device Sensing Problem; Device Sensing Problem

  THE CUSTOMER, A BIOMEDICAL ENGINEER CONTACTED PHYSIO-CONTROL TO REPORT THAT DURING TESTING, THEIR DEVICE WAS UNABLE TO DETECT THE CONNECTION OF THE DEFIBRILLATION THERAPY CABLE. THE CUSTOMER ADVISED THAT THE DEVICE PROMPTED THEM TO ¿CONNECT CABLE¿. IN THIS STATE, THE DEVICE WOULD BE INOPERABLE AND DEFIBRILLATION THERAPY WOULD NOT BE AVAILABLE IF NEEDED. THERE WAS NO REPORT OF PATIENT USE FOR THE REPORTED EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 8733105 ↗

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-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-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-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-0304-2024 · Sep 29, 2023 · Open, Classified
  LIFEPAK 15, REF: 99577-001958, Part Number: V15-7-000023
• Z-0296-2024 · Sep 29, 2023 · Open, Classified
  LIFEPAK 15, REF: 99577-000046, Part Number V15-2-000051
• Z-0299-2024 · Sep 29, 2023 · Open, Classified
  LIFEPAK 15, REF: 99577-001255, Part Number V15-2-001602
• Z-0303-2024 · Sep 29, 2023 · Open, Classified
  LIFEPAK 15, REF: 99577-001957, Part Number V15-5-000586 and V15-7-000022
• Z-0302-2024 · Sep 29, 2023 · Open, Classified
  LIFEPAK 15, REF: 99577-001956, Part Number V15-7-000021
• Z-0301-2024 · Sep 29, 2023 · Open, Classified
  LIFEPAK 15, REF: 99577-001955, Part Number V15-5-000584 and V15-7-000020
• Z-0300-2024 · Sep 29, 2023 · Open, Classified
  LIFEPAK 15, REF: 99577-001373, Part Number V15-7-000002
• Z-0305-2024 · Sep 29, 2023 · Open, Classified
  LIFEPAK 15, REF: 99577-001960, Part Number: V15-7-000026

…and 2 more.