Pad-Pak Pad-Pak-07Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 05060167124488), received between Apr 17, 2024 and Jan 14, 2026 — classified as 16 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (14 reports).

7 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 16, 2026.

Most reported problems

Recent adverse event reports

The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 14, 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 24065425 ↗
• MalfunctionJan 14, 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 24065422 ↗
• MalfunctionJan 13, 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 24064416 ↗
• MalfunctionJan 7, 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 23990028 ↗
• MalfunctionDec 31, 2025Material Deformation; Material 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 23931901 ↗
• MalfunctionDec 15, 2025Material Deformation; Material 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 23800284 ↗
• MalfunctionDec 12, 2025Material Deformation; Material 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 23787337 ↗
• MalfunctionDec 11, 2025Material Deformation; Material 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 23778650 ↗
• MalfunctionDec 11, 2025Material Deformation; Material 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 23778646 ↗
• MalfunctionDec 9, 2025Material Deformation; Material 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 23761404 ↗
• MalfunctionDec 3, 2025Material Deformation; Material 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 23704956 ↗
• MalfunctionNov 26, 2025Material Deformation; Material 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 23657673 ↗
• MalfunctionNov 11, 2025Material Deformation; Material 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 23524280 ↗
• MalfunctionNov 11, 2025Material Deformation; Material 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 23524186 ↗
• MalfunctionMay 7, 2024Failure to Power Up; Failure to Power Up

  THE CUSTOMER CONTACTED HEARTSINE TO REPORT THAT THEIR DEVICE COULD NOT BE POWERED ON WITH A SPECIFIC PAD-PAK. 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 19261198 ↗
• MalfunctionApr 17, 2024Failure to Power Up; Failure to Power Up

  THE CUSTOMER CONTACTED HEARTSINE TO REPORT THAT THEIR DEVICE COULD NOT BE POWERED ON WITH A PAD-PAK. 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 19127646 ↗

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