Pad-PakRecalls & reported problems across all models

We found 2 models of Pad-Pak by Heartsine Technologies Ltd in the FDA's device registry (GUDID). Together they are named in 545 adverse event reports in the FDA's MAUDE database, received between Feb 21, 2020 and Apr 23, 2026 — classified as 545 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (526 reports).

1 FDA recall record name at least one of these models by its device identifier, 1 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

Pad-Pak 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 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 · Recall details · FDA record ↗

Most reported Pad-Pak problems

Pad-Pak models

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

• Pad-Pak Pad-Pak-01

  Automated external defibrillators (non-wearable)
  1 recall529 reports
• Pad-Pak Pad-Pak-07

  Automated external defibrillators (non-wearable)
  16 reports

Recent Pad-Pak adverse event reports

The 15 most recent reports across all models, 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 ↗

Other Heartsine Technologies Ltd products

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