Pad-Pak Pad-Pak-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 529 adverse event reports that list this exact device (DI 05060167120466), received between Feb 21, 2020 and Apr 23, 2026 — classified as 529 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (512 reports).

1 FDA recall record 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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Apr 26, 2023Open, Classified

   Single use battery and electrode cartridge may be rendered inoperable due to depleted battery cells which could prevent the defibrillator from analyzing patient condition or delivering therapy correctly.

   Z-2143-2023 · Root cause: Process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 529 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 23, 2026Material Deformation

  THE CUSTOMER CONTACTED HEARTSINE TO REPORT THE PAD-PAK'S LOCATOR PIN IS BENT. THIS ISSUE CAN LEAD TO A FAILURE TO DETECT WHEN A PATIENT IS CONNECTED OR COULD CAUSE THE DEVICE TO LOSE POWER DURING OPERATION. THERE WAS NO REPORT OF PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24968412 ↗
• MalfunctionMar 30, 2026Failure to Power Up; Power Problem

  THE CUSTOMER CONTACTED HEARTSINE TO REPORT THAT THEIR DEVICE'S BATTERY WAS DEPLETED. AS A RESULT, THE DEVICE MAY NOT BE ABLE TO POWER ON TO DELIVER DEFIBRILLATION THERAPY, IF NEEDED. THERE WAS NO REPORT OF PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24735693 ↗
• MalfunctionMar 23, 2026Battery Problem

  THE CUSTOMER CONTACTED HEARTSINE TO REPORT THAT THEIR DEVICE'S PAD-PAK WAS DEAD, AND DOES NOT POWER ON THE DEVICE. 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 24671448 ↗
• MalfunctionMar 23, 2026Material Deformation

  IN RESPONSE TO A PRODUCT FIELD ACTION, THE CUSTOMER CONTACTED HEARTSINE TO REPORT THE PAD-PAK'S LOCATOR PIN IS BENT. THIS ISSUE CAN LEAD TO A FAILURE TO DETECT WHEN A PATIENT IS CONNECTED, OR COULD CAUSE THE DEVICE TO LOSE POWER DURING OPERATION. THERE WAS NO PATIENT INVOLVEMENT REPORTED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24665318 ↗
• MalfunctionMar 23, 2026Material Deformation

  IN RESPONSE TO A PRODUCT FIELD ACTION, THE CUSTOMER CONTACTED HEARTSINE TO REPORT THE PAD-PAK'S LOCATOR PIN IS BENT. THIS ISSUE CAN LEAD TO A FAILURE TO DETECT WHEN A PATIENT IS CONNECTED OR COULD CAUSE THE DEVICE TO LOSE POWER DURING OPERATION. THERE WAS NO PATIENT INVOLVEMENT REPORTED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24665137 ↗
• MalfunctionMar 23, 2026Material Deformation

  IN RESPONSE TO A PRODUCT FIELD ACTION, THE CUSTOMER CONTACTED HEARTSINE TO REPORT THE PAD-PAK'S LOCATOR PIN IS BENT. THIS ISSUE CAN LEAD TO A FAILURE TO DETECT WHEN A PATIENT IS CONNECTED OR COULD CAUSE THE DEVICE TO LOSE POWER DURING OPERATION. THERE WAS NO PATIENT INVOLVEMENT REPORTED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24665133 ↗
• MalfunctionFeb 26, 2026Material Deformation

  IN RESPONSE TO A PRODUCT FIELD ACTION, THE CUSTOMER CONTACTED HEARTSINE TO REPORT THE PAD-PAK'S LOCATOR PIN IS BENT. THIS ISSUE CAN LEAD TO A FAILURE TO DETECT WHEN A PATIENT IS CONNECTED OR COULD CAUSE THE DEVICE TO LOSE POWER DURING OPERATION. THERE WAS NO REPORT OF PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24455242 ↗
• MalfunctionFeb 26, 2026Material Deformation

  IN RESPONSE TO A PRODUCT FIELD ACTION, THE CUSTOMER CONTACTED HEARTSINE TO REPORT THE PAD-PAK'S LOCATOR PIN IS BENT. THIS ISSUE CAN LEAD TO A FAILURE TO DETECT WHEN A PATIENT IS CONNECTED OR COULD CAUSE THE DEVICE TO LOSE POWER DURING OPERATION. THERE WAS NO PATIENT INVOLVEMENT REPORTED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24454834 ↗
• MalfunctionFeb 26, 2026Material Deformation

  IN RESPONSE TO A PRODUCT FIELD ACTION, THE CUSTOMER CONTACTED HEARTSINE TO REPORT THE PAD-PAK'S LOCATOR PIN IS BENT. THIS ISSUE CAN LEAD TO A FAILURE TO DETECT WHEN A PATIENT IS CONNECTED, OR COULD CAUSE THE DEVICE TO LOSE POWER DURING OPERATION. THERE WAS NO REPORT OF PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24452688 ↗
• MalfunctionFeb 26, 2026Material Deformation

  IN RESPONSE TO A PRODUCT FIELD ACTION, THE CUSTOMER CONTACTED HEARTSINE TO REPORT THE PAD-PAK'S LOCATOR PIN IS BENT. THIS ISSUE CAN LEAD TO A FAILURE TO DETECT WHEN A PATIENT IS CONNECTED OR COULD CAUSE THE DEVICE TO LOSE POWER DURING OPERATION. THERE WAS NO REPORT OF PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24452392 ↗
• MalfunctionFeb 26, 2026Material Deformation

  IN RESPONSE TO A PRODUCT FIELD ACTION, THE CUSTOMER CONTACTED HEARTSINE TO REPORT THE PAD-PAK'S LOCATOR PIN IS BENT. THIS ISSUE CAN LEAD TO A FAILURE TO DETECT WHEN A PATIENT IS CONNECTED OR COULD CAUSE THE DEVICE TO LOSE POWER DURING OPERATION. THERE WAS NO REPORT OF PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24452391 ↗
• MalfunctionFeb 26, 2026Material Deformation

  IN RESPONSE TO A PRODUCT FIELD ACTION, THE CUSTOMER CONTACTED HEARTSINE TO REPORT THE PAD-PAK'S LOCATOR PIN IS BENT. THIS ISSUE CAN LEAD TO A FAILURE TO DETECT WHEN A PATIENT IS CONNECTED OR COULD CAUSE THE DEVICE TO LOSE POWER DURING OPERATION. THERE WAS NO REPORT OF PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24452331 ↗
• MalfunctionFeb 25, 2026Material Deformation

  IN RESPONSE TO A PRODUCT FIELD ACTION, THE CUSTOMER CONTACTED HEARTSINE TO REPORT THE PAD-PAK'S LOCATOR PIN IS BENT. THIS ISSUE CAN LEAD TO A FAILURE TO DETECT WHEN A PATIENT IS CONNECTED, OR COULD CAUSE THE DEVICE TO LOSE POWER DURING OPERATION. THERE WAS NO PATIENT INVOLVEMENT REPORTED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24443000 ↗
• MalfunctionFeb 25, 2026Material Deformation

  IN RESPONSE TO A PRODUCT FIELD ACTION, THE CUSTOMER CONTACTED HEARTSINE TO REPORT THE PAD-PAK'S LOCATOR PIN IS BENT. THIS ISSUE CAN LEAD TO A FAILURE TO DETECT WHEN A PATIENT IS CONNECTED, OR COULD CAUSE THE DEVICE TO LOSE POWER DURING OPERATION. THERE WAS NO PATIENT INVOLVEMENT REPORTED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24442986 ↗
• MalfunctionFeb 25, 2026Material Deformation

  IN RESPONSE TO A PRODUCT FIELD ACTION, THE CUSTOMER CONTACTED HEARTSINE TO REPORT THE PAD-PAK'S LOCATOR PIN IS BENT. THIS ISSUE CAN LEAD TO A FAILURE TO DETECT WHEN A PATIENT IS CONNECTED, OR COULD CAUSE THE DEVICE TO LOSE POWER DURING OPERATION. THERE WAS NO PATIENT INVOLVEMENT REPORTED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24442980 ↗
• MalfunctionFeb 25, 2026Material Deformation

  IN RESPONSE TO A PRODUCT FIELD ACTION, THE CUSTOMER CONTACTED HEARTSINE TO REPORT THE PAD-PAK'S LOCATOR PIN IS BENT. THIS ISSUE CAN LEAD TO A FAILURE TO DETECT WHEN A PATIENT IS CONNECTED, OR COULD CAUSE THE DEVICE TO LOSE POWER DURING OPERATION. THERE WAS NO PATIENT INVOLVEMENT REPORTED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24442978 ↗
• MalfunctionFeb 25, 2026Material Deformation

  IN RESPONSE TO A PRODUCT FIELD ACTION, THE CUSTOMER CONTACTED HEARTSINE TO REPORT THE PAD-PAK'S LOCATOR PIN IS BENT. THIS ISSUE CAN LEAD TO A FAILURE TO DETECT WHEN A PATIENT IS CONNECTED OR COULD CAUSE THE DEVICE TO LOSE POWER DURING OPERATION. THERE WAS NO PATIENT INVOLVEMENT REPORTED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24442977 ↗
• MalfunctionFeb 25, 2026Material Deformation

  IN RESPONSE TO A PRODUCT FIELD ACTION, THE CUSTOMER CONTACTED HEARTSINE TO REPORT THE PAD-PAK'S LOCATOR PIN IS BENT. THIS ISSUE CAN LEAD TO A FAILURE TO DETECT WHEN A PATIENT IS CONNECTED OR COULD CAUSE THE DEVICE TO LOSE POWER DURING OPERATION. THERE WAS NO PATIENT INVOLVEMENT REPORTED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24442976 ↗
• MalfunctionFeb 25, 2026Material Deformation

  IN RESPONSE TO A PRODUCT FIELD ACTION, THE CUSTOMER CONTACTED HEARTSINE TO REPORT THE PAD-PAK'S LOCATOR PIN IS BENT. THIS ISSUE CAN LEAD TO A FAILURE TO DETECT WHEN A PATIENT IS CONNECTED, OR COULD CAUSE THE DEVICE TO LOSE POWER DURING OPERATION. THERE WAS NO PATIENT INVOLVEMENT REPORTED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24442835 ↗
• MalfunctionFeb 25, 2026Material Deformation

  IN RESPONSE TO A PRODUCT FIELD ACTION, THE CUSTOMER CONTACTED HEARTSINE TO REPORT THE PAD-PAK'S LOCATOR PIN IS BENT. THIS ISSUE CAN LEAD TO A FAILURE TO DETECT WHEN A PATIENT IS CONNECTED OR COULD CAUSE THE DEVICE TO LOSE POWER DURING OPERATION. THERE WAS NO PATIENT INVOLVEMENT REPORTED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24442833 ↗
• MalfunctionFeb 23, 2026Failure to Power Up

  THE CUSTOMER CONTACTED HEARTSINE TO REPORT THAT THEIR PAD-PAK DID NOT POWER ON AN ASSOCIATED SAM PAD DEVICE. IN THIS STATE THE DEVICE MAY NOT BE ABLE TO DELIVER DEFIBRILLATION THERAPY IF IT WAS NEEDED. THERE WAS NO PATIENT INVOLVEMENT REPORTED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24414116 ↗
• MalfunctionFeb 23, 2026Material Deformation

  IN RESPONSE TO A PRODUCT FIELD ACTION, THE CUSTOMER CONTACTED HEARTSINE TO REPORT THE PAD-PAK'S LOCATOR PIN IS BENT. THIS ISSUE CAN LEAD TO A FAILURE TO DETECT WHEN A PATIENT IS CONNECTED OR COULD CAUSE THE DEVICE TO LOSE POWER DURING OPERATION. THERE WAS NO PATIENT INVOLVEMENT REPORTED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24413942 ↗
• MalfunctionFeb 23, 2026Material Deformation

  IN RESPONSE TO A PRODUCT FIELD ACTION, THE CUSTOMER CONTACTED HEARTSINE TO REPORT THE PAD-PAK'S LOCATOR PIN IS BENT. THIS ISSUE CAN LEAD TO A FAILURE TO DETECT WHEN A PATIENT IS CONNECTED OR COULD CAUSE THE DEVICE TO LOSE POWER DURING OPERATION. THERE WAS NO PATIENT INVOLVEMENT REPORTED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24413385 ↗
• MalfunctionFeb 23, 2026Material Deformation

  IN RESPONSE TO A PRODUCT FIELD ACTION, THE CUSTOMER CONTACTED HEARTSINE TO REPORT THE PAD-PAK'S LOCATOR PIN IS BENT. THIS ISSUE CAN LEAD TO A FAILURE TO DETECT WHEN A PATIENT IS CONNECTED, OR COULD CAUSE THE DEVICE TO LOSE POWER DURING OPERATION. THERE WAS NO PATIENT INVOLVEMENT REPORTED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24413144 ↗
• MalfunctionFeb 20, 2026Material Deformation

  IN RESPONSE TO A PRODUCT FIELD ACTION, THE CUSTOMER CONTACTED HEARTSINE TO REPORT THE PAD-PAK'S LOCATOR PIN IS BENT. THIS ISSUE CAN LEAD TO A FAILURE TO DETECT WHEN A PATIENT IS CONNECTED OR COULD CAUSE THE DEVICE TO LOSE POWER DURING OPERATION. THERE WAS NO PATIENT INVOLVEMENT REPORTED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24406199 ↗

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-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
• Z-0745-2022 · Jan 13, 2022 · Terminated
  HeartSine Samaritan PAD, SAM 350P Semi-Automatic Defibrillator, used with Pad-Pak