HeartSine Samaritan PAD 450PRecalls & reported problems across all models

We found 5 models of HeartSine Samaritan PAD 450P by Heartsine Technologies Ltd in the FDA's device registry (GUDID). Together they are named in 23 adverse event reports in the FDA's MAUDE database, received between Aug 20, 2021 and May 6, 2026 — classified as 2 deaths, 21 malfunctions.

The most frequently reported specific device problem is “Failure to Power Up” (11 reports).

3 FDA recall records name at least one of these models by its device identifier, 2 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 450P 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. 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 ↗

2. 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 ↗

3. Jan 13, 2022Class IIITerminated

   Semi-automatic defibrillators shipped out by Stryker without battery and electrode packs.

   Z-0745-2022 · Root cause: Process control · Recall details · FDA record ↗

Most reported HeartSine Samaritan PAD 450P problems

HeartSine Samaritan PAD 450P models

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

• HeartSine Samaritan PAD 450P SAM450P

  Automated external defibrillators (non-wearable)
  2 recalls2 deaths23 reports
• HeartSine Samaritan PAD 450P SAM450P

  Automated external defibrillators (non-wearable)
  1 recall0 reports
• HeartSine Samaritan PAD 450P SAM450P

  Automated external defibrillators (non-wearable)
  1 recall0 reports
• HeartSine Samaritan PAD 450P SAM 450P

  Automated external defibrillators (non-wearable)
  1 recall0 reports
• HeartSine Samaritan PAD 450P SAM450P

  Automated external defibrillators (non-wearable)
  1 recall0 reports

Recent HeartSine Samaritan PAD 450P adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionMay 6, 2026Failure to Power Up

  A CUSTOMER CONTACTED HEARTSINE TO REPORT THAT THEIR DEVICE'S POWER BUTTON DOES NOT FUNCTION. IN THIS STATE THE DEVICE WOULD BE INOPERABLE AND DEFIBRILLATION THERAPY WOULD NOT BE AVAILABLE IF IT WAS NEEDED. THERE WAS NO PATIENT INVOLVEMENT REPORTED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25091199 ↗
• MalfunctionApr 1, 2026No Audible Prompt/Feedback

  THE CUSTOMER CONTACTED HEARTSINE TO REPORT THAT THEIR DEVICE DOES NOT PROVIDE AUDIBLE INSTRUCTION WHEN POWERED ON. WITHOUT VOICE PROMPTS, A LAY USER WOULD NOT RECEIVE THE AUDIBLE INSTRUCTIONS ON HOW TO PROPERLY USE THE DEVICE TO DELIVER DEFIBRILLATION THERAPY TO A PATIENT. THERE WAS NO PATIENT INVOLVEMENT REPORTED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24754462 ↗
• MalfunctionSep 8, 2025Failure to Power Up; Device Sensing Problem; Failure to Power Up; Device Sensing Problem

  HEARTSINE CONTACTED STRYKER TO REPORT THAT THEIR DEVICE FAILED TO ANALYZE RHYTHM DURING AN INTERVENTION. THERE WAS NO HARM TO THE PATIENT AS A RESULT OF THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22994127 ↗
• MalfunctionAug 25, 2025No Audible Prompt/Feedback; No Audible Prompt/Feedback

  THE 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 22889957 ↗
• MalfunctionJul 23, 2025Failure to Sense; Failure to Sense

  THE CUSTOMER CONTACTED HEARTSINE TO REPORT THAT THEIR DEVICE HAD FAILED TO DETECT A PATIENT IMPEDANCE DURING A PATIENT INVOLVED 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 22574224 ↗
• MalfunctionJun 19, 2025Failure to Analyze Signal; Failure to Analyze Signal

  THE CUSTOMER CONTACTED HEARTSINE TO REPORT THAT THEIR DEVICE DID NOT ANALYZE WHEN CONNECTED TO A PATIENT. IN THIS STATE, DEFIBRILLATION THERAPY MAY BE DELAYED OR PREVENTED FROM BEING DELIVERED TO THE PATIENT IF NEEDED. THE PATIENT DID NOT SURVIVE.

  Patient problems: Cardiac Arrest

  MAUDE report 22294185 ↗
• MalfunctionJun 5, 2025Failure to Power Up; Failure 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 22154775 ↗
• MalfunctionJan 14, 2025No Audible Prompt/Feedback; No Audible Prompt/Feedback

  THE CUSTOMER CONTACTED HEARTSINE TO REPORT THAT THEIR DEVICE FAILED TO ISSUE AUDIO 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 21147115 ↗
• MalfunctionJan 10, 2025Program or Algorithm Execution Problem; Program or Algorithm Execution Problem

  HEARTSINE RECALLED THE DEVICE UNDER FA301. UPON RECEIPT AT HEARTSINE, THE INVESTIGATION DISCOVERED THE DEVICE HAD BEEN INCORRECTLY PROGRAMMED DURING THE MANUFACTURING PROCESS. IN THIS STATE THE DEVICE WOULD NOT BE ABLE TO DELIVER THERAPY TO SPECIFICATION. THERE WAS NO PATIENT INVOLVEMENT REPORTED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21124415 ↗
• MalfunctionOct 23, 2024Failure to Power Up; Failure to Power Up

  THE CUSTOMER CONTACTED HEARTSINE TO REPORT THAT THEIR DEVICE COULD NOT 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 20512362 ↗
• MalfunctionSep 17, 2024Failure to Power Up; Failure to Power Up

  THE CUSTOMER CONTACTED HEARTSINE TO REPORT THAT THEIR DEVICE COULD NOT 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 20241921 ↗
• MalfunctionSep 10, 2024No Audible Prompt/Feedback; No Audible Prompt/Feedback

  THE CUSTOMER CONTACTED HEARTSINE TO REPORT THAT THEIR DEVICE FAILED TO DELIVER VOICE PROMPTS AT POWER UP. 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 20186823 ↗
• MalfunctionJul 23, 2024Failure to Power Up; Failure to Power Up

  THE CUSTOMER CONTACTED HEARTSINE TO REPORT THAT THEIR DEVICE COULD NOT 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 19809793 ↗
• DeathJun 27, 2024No Audible Prompt/Feedback; No Audible Prompt/Feedback

  THE CUSTOMER CONTACTED HEARTSINE TO REPORT THAT THEIR DEVICE ISSUED NO VOICE PROMPTS DURING A PATIENT INVOLVED EVENT. IN THIS STATE THE DEVICE MAY NOT BE ABLE TO DELIVER DEFIBRILLATION THERAPY IF NEEDED. THE PATIENT INVOLVED IN THE REPORTED EVENT IS DECEASED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19630619 ↗
• MalfunctionJun 26, 2024No Audible Prompt/Feedback; No Audible Prompt/Feedback

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19613475 ↗

Other Heartsine Technologies Ltd products

• Pad-Pak2 models · 545 reports · 1 recall
• samaritan PAD2 models · 304 reports
• HeartSine Samaritan PAD 350P4 models · 83 reports · 4 recalls
• HeartSine Samaritan PAD 360P4 models · 19 reports · 1 recall