The Recall Desk
HighFDA (Devices)·Z-2143-2023·Announced 2023-07-19

HeartSine Defibrillator Battery and Electrode Cartridges May Fail to Function

HeartSine battery and electrode cartridges for defibrillators may contain depleted battery cells, rendering them inoperable and preventing cardiac rhythm analysis or therapy delivery. Approximately 30,022 units are affected worldwide.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is a Class II recall with no reported hospitalizations or injuries. However, it concerns a life-critical medical device where functional failure could prevent emergency therapy delivery. Per the rubric, risk-of-harm products without reported injury are scored at 3 (High).

Plain-English summary

HeartSine Technologies Ltd is recalling single-use battery and electrode cartridges (PAD-PAK-01, PAD-PAK-03, and PAD-PAK-03j) used with HeartSine Samaritan Public Access Defibrillator models 350P, 360P, 450P, and 500P. The cartridges may contain depleted battery cells that could render them inoperable and prevent the defibrillator from analyzing the patient's cardiac condition or delivering electrical therapy.

The recall affects approximately 30,022 units distributed worldwide, including throughout all U.S. states and internationally to Australia, Canada, Denmark, France, Iceland, Ireland, Israel, Italy, Japan, Korea, Netherlands, New Zealand, Peru, Poland, Singapore, South Africa, Spain, Thailand, and the United Kingdom.

Users should verify whether their defibrillator cartridges match the affected lot numbers listed in the FDA recall notice. Facilities using affected devices should replace recalled cartridges following the manufacturer's instructions and ensure replacement cartridges are functional before returning the defibrillator to service.

The recalled product

Product
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
Manufacturer
HeartSine Technologies Ltd
Category
Medical Device — Defibrillator / Battery and Electrode Cartridge
Hazard
  • battery-failure
  • device-inoperability

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • Model #/UDI-DI #: 360-BAS-UK-10/05060167122606
  • 350-BAS-UK-10/05060167121418
  • 350-BAS-AS-10/05060167121371
  • 350-BAS-CF-10/05060167124747
  • 350-BAS-CN-10/05060167121593
  • 350-BAS-JA-08/05060167124525
  • 350-BAS-KO-10/05060167121517
  • 350-BAS-MS-10/05060167120800
  • 350-BAS-USROW-10/05060167121630
  • 360-BAS-AS-10/05060167122514
  • 360-BAS-CN-10/05060167125751
  • 360-BAS-KO-10/05060167122712
  • 360-BAS-SJ-10/05060167128028
  • 450-BAS-JA-08/05060167127663
  • 500-BAS-AS-10/05060167125812
  • 500-BAS-CF-10/05060167125836
  • 500-BAS-CN-10/05060167125843
  • 500-BAS-KO-10/05060167126444
  • 500-BAS-TH-10/05060167125997
  • 500-BAS-UK-10/05060167122453

Distribution

Distributed nationwide across the United States.

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