HeartSine Samaritan PAD 350P SAM 350P (REF 350-STR-US-10)Recalls & reported problems

Summary

The FDA's MAUDE database contains 83 adverse event reports that list this exact device (DI 05060167120671), received between May 27, 2021 and May 26, 2026 — classified as 2 deaths, 2 injuries, 79 malfunctions.

The most frequently reported specific device problem is “Failure to Power Up” (31 reports).

3 FDA recall records name this device's identifier, 3 still open.

6 other recalls cover devices cleared under the same FDA submission (P160008); 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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Apr 8, 2024Open, Classified

   Automated external defibrillators have a manufacturing issue that could prevent the device from delivering instructional voice prompts to the user during use of the device. Visual instructional icons will still be present, but this issue could potentially lead to no therapy or a delay in therapy.

   Z-1820-2024 · Root cause: Process control · FDA record ↗

2. Feb 14, 2024Open, Classified

   Automated external defibrillators were shipped in their test configuration so there is a potential to have incorrect language, and CPR duration resulting in the device prompting users to perform CPR for 5-seconds, and it could analyze heart rhythm and instruct users to deliver a shock every 5-seconds if a shockable heart rhythm is detected, potentially leading to no therapy or delayed therapy.

   Z-1141-2024 · Root cause: Process control · FDA record ↗

3. Feb 1, 2023Open, Classified

   Automated external defibrillators were potentially distributed with the incorrect language configuration, which can lead to a delay in therapy or no therapy.

   Z-1217-2023 · Root cause: Process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 83 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 26, 2026No Audible Prompt/Feedback

  THE CUSTOMER CONTACTED HEARTSINE TO REPORT THAT THEIR DEVICE IS NOT GIVING ANY AUDIBLE PROMPTS. WITHOUT AUDIBLE PROMPTS, A USER MAY BE UNABLE TO USE THE DEVICE TO DELIVER DEFIBRILLATION THERAPY TO A PATIENT, IF NEEDED. THERE WAS NO REPORT OF PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25280047 ↗
• MalfunctionApr 10, 2026Failure to Power Up

  THE CUSTOMER CONTACTED HEARTSINE TO REPORT THAT THEIR DEVICE WILL NOT POWER ON. 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 24843563 ↗
• MalfunctionMar 4, 2026Electrical /Electronic Property Problem; Audible Prompt/Feedback Problem

  A CUSTOMER CONTACTED HEARTSINE TO REPORT THAT THEIR DEVICE PROMPTED "CHILD MODE" WHILE AN ADULT CARTRIDGE WAS INSERTED. AS PATIENT IMPEDANCE INCREASES, THE SENSING OF A CHILD PATIENT WHEN AN ADULT PAD-PAK IS INSERTED WILL LIKELY RESULT IN A REDUCED SHOCK ENERGY BEING DELIVERED TO THE PATIENT. AS A RESULT, WRONG DEFIBRILLATION THERAPY MAY BE DELIVERED. THERE WAS NO REPORT OF PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24505726 ↗
• MalfunctionFeb 17, 2026No Audible Prompt/Feedback

  A CUSTOMER CONTACTED HEARTSINE TO REPORT THAT THEIR DEVICE WOULD NOT PROVIDE AUDIO VOICE PROMPTS. WITHOUT VOICE PROMPTS, A LAY USER WOULD NOT RECEIVE THE AUDIBLE INSTRUCTIONS ON HOW TO PROPERLY USE THE DEVICE ON A PATIENT WHICH COULD DELAY THERAPY. THERE WAS NO REPORT OF PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24363249 ↗
• MalfunctionFeb 11, 2026Failure to Power Up

  THE CUSTOMER CONTACTED HEARTSINE TO REPORT THAT THEIR DEVICE WOULD NOT POWER ON. IN THIS STATE, THE DEVICE WOULD BE INOPERABLE AND 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 24313315 ↗
• MalfunctionFeb 2, 2026Audible Prompt/Feedback Problem

  THE CUSTOMER CONTACTED HEARTSINE TO REPORT THAT THEIR DEVICE WOULD NOT PROVIDE ANY VOICE PROMPTS. WITHOUT VOICE PROMPTS, THE USER WOULD NOT BE ABLE TO USE THE DEVICE PROPERLY ON A PATIENT IF NEEDED. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24230834 ↗
• MalfunctionJan 7, 2026Failure to Power Up

  THE CUSTOMER CONTACTED HEARTSINE TO REPORT THAT THEIR DEVICE WOULD NOT POWER ON. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23988131 ↗
• MalfunctionJan 6, 2026Failure to Power Up

  THE CUSTOMER CONTACTED HEARTSINE TO REPORT THEIR DEVICE WOULD NOT POWER ON. 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 23976921 ↗
• MalfunctionOct 15, 2025No Audible Prompt/Feedback; No Audible Prompt/Feedback

  A CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE WOULD NOT PROVIDE AUDIO VOICE PROMPTS. WITHOUT VOICE PROMPTS, A LAY USER WOULD NOT RECEIVE THE AUDIBLE INSTRUCTIONS ON HOW TO PROPERLY USE THE DEVICE ON A PATIENT WHICH COULD DELAY THERAPY. THERE WAS NO REPORT OF PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23299979 ↗
• MalfunctionOct 9, 2025Unexpected Shutdown; Unexpected Shutdown

  THE CUSTOMER CONTACTED HEARTSINE TO REPORT THEIR DEVICE LOST POWER. 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 23260412 ↗
• MalfunctionSep 15, 2025No Audible Prompt/Feedback; No Audible Prompt/Feedback

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR PED PAK HAD NOT MADE PROPER CONTACT WITH THE DEVICE AND THAT CONSEQUENTLY THE DEVICE EXPERIENCED A RECURRING LOOP, REPEATEDLY PLAYING THE SAME VOICE PROMPT WITHOUT ADVANCING TO THE SUBSEQUENT STEP. THE PATIENT ASSOCIATED WITH THE REPORTED EVENT DID NOT SURVIVE. THE CUSTOMER CONFIRMED THAT THE DEVICE USE DID NOT CONTRIBUTE TO THE PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23059669 ↗
• MalfunctionSep 15, 2025Audible Prompt/Feedback Problem; Audible Prompt/Feedback Problem

  THE CUSTOMER CONTACTED HEARTSINE TO REPORT THAT THEIR DEVICE WAS SET UP IN THE INCORRECT LANGUAGE. WITHOUT VOICE PROMPTS IN THE CORRECT LANGUAGE, A LAY USER WOULD NOT RECEIVE THE AUDIBLE INSTRUCTIONS ON HOW TO PROPERLY USE THE DEVICE ON A PATIENT WHICH COULD DELAY THERAPY. THERE WAS NO PATIENT INVOLVEMENT REPORTED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23053531 ↗
• MalfunctionAug 28, 2025Failure to Power Up; Failure to Power Up

  THE CUSTOMER CONTACTED HEARTSINE TO REPORT THAT THEIR DEVICE DOES NOT TURN ON. THERE WAS NO PATIENT INVOLVEMENT REPORTED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22910627 ↗
• MalfunctionJul 11, 2025Failure to Power Up; Failure to Power Up

  THE CUSTOMER CONTACTED HEARTSINE TO REPORT THAT THEIR DEVICE WAS NOT ABLE TO POWER ON. IN THIS STATE THE DEVICE MAY NOT BE ABLE TO DELIVER DEFIBRILLATION THERAPY, IF NEEDED. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22481807 ↗
• InjuryJun 26, 2025Failure to Deliver Shock/Stimulation; Failure to Deliver Shock/Stimulation

  THE CUSTOMER CONTACTED HERATSINE TO REPORT THAT THEIR DEVICE DID NOT DELIVER A SHOCK DURING A PATIENT EVENT. 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 22336087 ↗
• MalfunctionMay 9, 2025No Audible Prompt/Feedback; No Audible Prompt/Feedback

  A CUSTOMER CONTACTED HEARTSINE TO REPORT THAT THEIR DEVICE WOULD NOT PROVIDE AUDIO VOICE PROMPTS. WITHOUT VOICE PROMPTS, A LAY USER WOULD NOT RECEIVE THE AUDIBLE INSTRUCTIONS ON HOW TO PROPERLY USE THE DEVICE ON A PATIENT WHICH COULD DELAY THERAPY. THERE WAS NO REPORT OF PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21994095 ↗
• MalfunctionApr 25, 2025No Audible Prompt/Feedback; No Audible Prompt/Feedback

  THE CUSTOMER CONTACTED HEARTSINE TO REPORT THAT THEIR DEVICE WOULD NOT EMIT AUDIO PROMPTS. WITHOUT VOICE PROMPTS, A LAY USER WOULD NOT RECEIVE THE AUDIBLE INSTRUCTIONS ON HOW TO PROPERLY USE THE DEVICE ON A PATIENT, IF NEEDED. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21910526 ↗
• InjuryApr 17, 2025No Audible Prompt/Feedback; No Audible Prompt/Feedback

  THE CUSTOMER CONTACTED HEARTSINE TO REPORT THEIR DEVICE STOPPED GIVING VOICE PROMPTS WHILE IN USE. WITHOUT VOICE PROMPTS, A LAY USER WOULD NOT RECEIVE THE AUDIBLE INSTRUCTIONS ON HOW TO PROPERLY USE THE DEVICE ON A PATIENT. THIS ISSUE IS PATIENT RELATED AND THE PATIENT SURVIVED THE EVENT.

  Patient problems: Cardiac Arrest

  MAUDE report 21861676 ↗
• MalfunctionMar 25, 2025No Audible Prompt/Feedback; No Audible Prompt/Feedback

  THE CUSTOMER CONTACTED HEARTSINE TO REPORT THAT THEIR DEVICE DID NOT PROVIDE VOICE PROMPTS. WITHOUT VOICE PROMPTS, A LAY USER WOULD NOT RECEIVE THE AUDIBLE INSTRUCTIONS ON HOW TO PROPERLY USE THE DEVICE ON A PATIENT WHICH COULD DELAY THERAPY. THERE WAS NO REPORT OF PATIENT USE ASSOCIATED TO THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21688603 ↗
• MalfunctionFeb 26, 2025Failure to Power Up; Failure to Power Up

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21470242 ↗
• MalfunctionFeb 26, 2025Failure to Power Up; Failure to Power Up

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21470229 ↗
• MalfunctionFeb 7, 2025Failure to Power Up; Failure to Power Up

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21336985 ↗
• MalfunctionFeb 3, 2025Audible Prompt/Feedback Problem; Audible Prompt/Feedback Problem

  THE CUSTOMER CONTACTED HEARTSINE TO REPORT THAT THEIR DEVICE FAILED TO ISSUE VOICE PROMPTS FOR UP TO 9 SECONDS UPON POWERING ON THE DEVICE. WITH A DELAY IN VOICE PROMPT DELIVERY, A LAY USER WOULD NOT RECEIVE THE AUDIBLE INSTRUCTIONS ON HOW TO PROPERLY USE THE DEVICE ON A PATIENT WHICH COULD DELAY THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21294387 ↗
• MalfunctionJan 28, 2025Failure to Power Up; Failure to Power Up

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21252371 ↗
• MalfunctionJan 8, 2025No Audible Prompt/Feedback; No Audible Prompt/Feedback

  THE CUSTOMER CONTACTED HEARTSINE TO REPORT THAT THEIR DEVICE FAILED TO ISSUE VOICE PROMPTS AT POWER UP. WITHOUT VOICE PROMPTS, A LAY USER WOULD NOT RECEIVE THE AUDIBLE INSTRUCTIONS ON HOW TO PROPERLY USE THE DEVICE ON A PATIENT WHICH COULD DELAY THERAPY. THERE WAS NO PATIENT INVOLVEMENT REPORTED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21100962 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P160008. One submission often covers many models, so check the product and lot details in each record.

• Z-3120-2026 · Jul 27, 2026 · Open, Classified
  HeartSine SAM 350P 350P US Device, US English - 2 Min CPR UDI-DI codes: 0506016712067 350P US Device, US English (American Airlines) - 2 Min CPR UDI-DI code: 0506016712207 350P U
• Z-3270-2026 · Jul 27, 2026 · Open, Classified
  HeartSine samaritan PAD (Public Access Defibrillator); HeartSine SAM 350P 350P US Device, US English - 2 Min CPR UDI-DI codes: 0506016712067 350P US Device, US English (Americ
• Z-0288-2026 · Sep 18, 2025 · Open, Classified
  HeartSine Pad-Pak, REF: PAD-PAK-01, PAD-PAK-02, PAD-PAK-03, PAD-PAK-04, PAD-PAK-07, PAD-PAK-03J, PAD-PAK-04J
• Z-2174-2025 · Jun 30, 2025 · Open, Classified
  HeartSine SAM 350P, HeartSine SAM 360P, and HeartSine SAM 450P The HeartSine samaritan PAD (Public Access Defibrillator)
• Z-2143-2023 · Apr 26, 2023 · Open, Classified
  HeartSine, REF: PAD-PAK-01, PAD-PAK-03 AND PAD-PAK-03j, CE0123 sold separately and with the HeartSine Samaritan Public Access Defibrillator models: 350P/360P/450P/500P
• Z-0745-2022 · Jan 13, 2022 · Terminated
  HeartSine Samaritan PAD, SAM 350P Semi-Automatic Defibrillator, used with Pad-Pak