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Recall Observatory FDA recall evidence

Device product

Defibtech DDP-100 Adult Defibrillation Pads For use with AED Models: Lifeline and Lifeline Auto (DDU-1:XX Series)- Indicated for use on victims of sudden cardiac arrest (SCA)

Z-0502-2025

October 14, 2024

Class II

Product summary

Firm
Defibtech, LLC
Event
Event 95594
Status
Ongoing
Classification
Class II
Quantity
22,294 total
Official record key
device-enforcement:Z-0502-2025

Official wording

Reason: Within the Irish Market, a Field Safety Notice is being issued due to a select number of authorized labelled Defibtech AED Pads, which have had the authorized label removed and an unauthorized label applied, could lead to expired Defibtech AED Pads appearing as though they are within the acceptable shelf life. There is a possibility of hydrogel drying, which may result in poor electrical connection to the patient, which can reduce the energy delivered to the patient.

Code information: UDI-DI: 00815098020423, DDP-100 adult defibrillation pads, single configuration; 30815098020424, DDP-100 adult defibrillation pads, 10 pairs; 50815098020428, DDP-100 adult defibrillation pads, 40 pairs;

Distribution pattern: Ireland

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Within the Irish Market, a Field Safety Notice is being issued due to a select number of authorized labelled Defibtech AED Pads, which have had the authorized label removed and an unauthorized label applied, could lead to expired Defibtech AED Pads appearing as though they are within the acceptable shelf life. There is a possibility of hydrogel drying, which may result in poor electrical connection to the patient, which can reduce the energy delivered to the patient.