HeartSine Samaritan PAD 350PRecalls & reported problems across all models

We found 4 models of HeartSine Samaritan PAD 350P by Heartsine Technologies Ltd in the FDA's device registry (GUDID). Together they are named in 83 adverse event reports in the FDA's MAUDE database, 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).

4 FDA recall records name at least one of these models by its device identifier, 4 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

HeartSine Samaritan PAD 350P recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Jun 30, 2025Class IIOpen, Classified

   Due to a component manufacturing issue, Automated External Defibrillator may not function properly (deliver shocks)

   Z-2174-2025 · Root cause: Process change control · Recall details · FDA record ↗

2. Apr 8, 2024Class IIOpen, 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 · names 4 of these models · Recall details · FDA record ↗

3. Feb 14, 2024Class IIOpen, 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 · Recall details · FDA record ↗

4. Feb 1, 2023Class IIOpen, 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 · Recall details · FDA record ↗

Most reported HeartSine Samaritan PAD 350P problems

HeartSine Samaritan PAD 350P models

4 models, most reported first. Each model has its own page with its reports, recalls and device details.

• HeartSine Samaritan PAD 350P SAM 350P

  Automated external defibrillators (non-wearable)
  3 recalls2 deaths83 reports
• HeartSine Samaritan PAD 350P SAM 350P

  Automated external defibrillators (non-wearable)
  2 recalls0 reports
• HeartSine Samaritan PAD 350P SAM 350P

  Automated external defibrillators (non-wearable)
  1 recall0 reports
• HeartSine Samaritan PAD 350P SAM 350P

  Automated external defibrillators (non-wearable)
  1 recall0 reports

Recent HeartSine Samaritan PAD 350P adverse event reports

The 15 most recent reports across all models, 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 ↗

Other Heartsine Technologies Ltd products

• Pad-Pak2 models · 545 reports · 1 recall
• samaritan PAD2 models · 304 reports
• HeartSine Samaritan PAD 450P5 models · 23 reports · 3 recalls
• HeartSine Samaritan PAD 360P4 models · 19 reports · 1 recall