Heartsine Samaritan Pad-Pak Supply Disruption 2025-2026

Heartsine Samaritan Pad-Pak Supply Disruption 2025-2026

Overview

From mid‑2025, the availability of HeartSine Pad‑Paks in Australia became constrained, resulting in extended lead times and limited routine supply.  
This disruption was primarily caused by regulatory corrective actions, rather than general logistics or shipping issues.

The supply constraint occurred alongside broader remedial actions affecting HeartSine Samaritan AED products.

Cause of the Supply Disruption

  1. Critical Product Correction – Pad‑Paks

A Critical Product Correction was initiated for certain HeartSine Pad‑Paks following the identification of a manufacturing issue involving:
  1. Bent or misaligned locator pins
  2. Risk of improper Pad‑Pak insertion, which could prevent therapy delivery
The action applied to Pad‑Paks with a wide range of expiry dates, covering a significant proportion of stock already in the field and in distribution channels.
  1. Impact on Manufacturing and Distribution
As part of the corrective action:
  1. Manufacturing output was prioritised for replacement Pad‑Paks
  2. Production capacity was diverted away from routine commercial supply
  3. Replacement Pad‑Paks were issued through controlled remediation processes, rather than standard purchasing
This resulted in reduced availability for new orders and routine replacements.

Practical Impact on Users

Users and distributors continue to experience:
  1. Extended lead times for replacement Pad‑Paks
  2. Limited availability for new AED installations
  3. Increased reliance on inspection and continued use guidance

Managing Expired Pad-Paks

To manage risk during constrained supply, guidance allowed Pad‑Paks to remain in service provided they were inspected and confirmed to be undamaged and correctly seated. 
Info
*See Attached Advice Regarding Expired Pad-Paks
*select attachments tab

Relationship to the AED Recall

The Pad‑Pak supply disruption occurred in parallel with the June 2025 recall of certain HeartSine Samaritan AED units related to an electronic component issue.

Together, these actions resulted in:
  1. Increased demand for replacement components
  2. Competing priorities for manufacturing capacity
  3. Prolonged remediation timelines for both AED units and consumables
While the AED recall and Pad‑Pak correction addressed different technical issues, their overlap compounded supply limitations.

Current Status - Jan 2026

  1. The Pad‑Pak corrective action remains subject to ongoing regulatory oversight
  2. Replacement Pad‑Paks are supplied on a prioritised, case‑by‑case basis
  3. Users are advised to retain functional Pad‑Paks in service until replacements are provided
A small number of new Pad-Paks have started arriving for distribution in Australia; however, normal commercial supply has not yet been fully restored.

Summary

  1. Pad‑Pak supply disruption continues in Australia and is expected to continue in the first half of 2026
  2. The disruption was caused by a regulatory corrective action, not a general shortage  
  3. Manufacturing capacity is redirected to replacement stock
  4. Routine purchasing experienced delays and limited availability continues
  5. Continued use of inspected Pad‑Paks is permitted during the remediation period