HeartSine Samaritan PAD 450P SAM450P (REF 450-STR-US-10)Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 05060167120695), 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).

2 FDA recall records name this device's identifier, 1 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

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 · Recall details · FDA record ↗

2. 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 problems

Recent adverse event reports

The 23 most recent of 23 reports, 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 ↗
• MalfunctionFeb 14, 2024Failure to Power Up; Battery Problem; Failure to Power Up; Battery Problem

  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 18705200 ↗
• MalfunctionFeb 12, 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 18690648 ↗
• MalfunctionNov 20, 2023Failure to Power Up; Failure to Power Up

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18167844 ↗
• MalfunctionAug 1, 2023No Audible Prompt/Feedback; Unexpected Shutdown; No Audible Prompt/Feedback; Unexpected Shutdown

  THE CUSTOMER CONTACTED HEARTSINE TO REPORT THAT THEIR DEVICE EXPERIENCES UNEXPECTED LOSSES OF POWER. IN THIS STATE THE DEVICE WOULD BE INOPERABLE AND DEFIBRILLATION THERAPY WOULD NOT BE AVAILABLE IF NEEDED. THERE WAS NO REPORT OF PATIENT USE ASSOCIATED TO THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17435632 ↗
• MalfunctionJun 30, 2023Failure to Sense; Failure to Sense

  THE CUSTOMER CONTACTED HEARTSINE TO REPORT THAT THEIR DEVICE KEPT PROMPTING "CONNECT PADS" WHEN THE DEFIBRILLATION ELECTRODES HAD ALREADY BEEN APPLIED TO THE PATIENT. IN THIS STATE THE DEVICE MAY NOT BE ABLE TO DELIVER DEFIBRILLATION THERAPY, IF NEEDED. THIS ISSUE IS PATIENT RELATED; HOWEVER, NO ADVERSE EVENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17235410 ↗
• MalfunctionJun 22, 2023Failure 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 17180340 ↗
• DeathNov 1, 2022Failure to Sense; Failure to Sense

  THE CUSTOMER CONTACTED HEARTSINE TO REPORT THAT THEIR DEVICE DID NOT PERFORM ANALYSIS. IN THIS STATE THE DEVICE MAY NOT BE ABLE TO DELIVER DEFIBRILLATION THERAPY IF NEEDED. THE PATIENT ASSOCIATED WITH THE REPORTED EVENT DID NOT SURVIVE. IT IS UNKNOWN IF THE DEVICE CONTRIBUTED TO THE ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15710233 ↗
• MalfunctionAug 20, 2021Failure to Power Up; Defective Component; Electrical Power Problem; Power Problem; Failure to Power Up; Electrical Power Problem

  REPORT ALLEGES ON/OFF BUTTON IS FAULTY. FAILURE TO POWER ON DEVICE MAY PREVENT OR DELAY DEFIBRILLATION, WHICH COULD CAUSE AN ADVERSE EVENT. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12346895 ↗

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-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-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-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-1217-2023 · Feb 1, 2023 · Open, Classified
  Heartsine Samaritan PAD: SAM 350P semi-automatic defibrillator, SAM 360P fully automatic defibrillator, SAM 500P semi-automatic defibrillator with CPR Advisor