The Recall Desk

Hazard

Failure To Deliver Therapy recalls

7 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
7
Critical
1
Severe
3
Most recent
2021-01-27

Of the 7 failure to deliver therapy recalls we have scored against our rubric, 1 (14%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 3 (43%) are Severe.

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all failure to deliver therapy recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

1–7 of 7

  • CriticalFDA (Devices)·Z-0879-2021·2021-01-27

    Boston Scientific Recalls Emblem S-ICD Subcutaneous Electrodes Due to Fracture Risk

    Boston Scientific is recalling Emblem S-ICD Subcutaneous Electrodes because fractures may prevent the device from delivering therapy.

    Product
    EMBLEM S-ICD Subcutaneous Electrode Model 3501. Component of implantable cardioverter defibrillator (ICD)
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0294-2018·2018-01-17

    Physio-Control Recalls LIFEPAK 20e Defibrillators Due to Power Failures

    Physio-Control is recalling 3,831 LIFEPAK 20e defibrillators because power-related failures could prevent the device from delivering therapy, potentially causing serious injury or death.

    Product
    LIFEPAK 20e DEFIBRILLATOR/MONITOR, 3201273 Product Usage: The LIFEPAK 20e defibrillator/monitor is intended for use in the hospital, physician s office, and clinic setting by personnel who are authorized by a physician/medical director. It is intended for use on a crash cart
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1660-2014·2014-06-04

    Physio-Control Recalls LIFEPAK 1000 Defibrillators Due to Unexpected Shutdowns

    Physio-Control is recalling 96,611 LIFEPAK 1000 defibrillators because a software malfunction can cause the device to shut down unexpectedly, potentially failing to deliver a life-saving shock.

    Product
    LIFEPAK 1000 defibrillator. Affected Part Numbers: 320371500XXX The LP1000 (in AED mode) is indicated for use on patients in cardiac arrest.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1439-2014·2014-04-16

    Philips HeartStart XL+ Defibrillator Recalled for Therapy Board Malfunction

    Philips is recalling 19 HeartStart XL+ defibrillators because a therapy board component could malfunction, potentially affecting the device's ability to deliver therapy.

    Product
    Philips HeartStart XL+ Defibrillator/Monitor Model number: 861290, automatic external defibrillator.
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1232-2014·2014-03-26

    Philips Recalls HeartStart Home and OnSite AEDs Due to Solder Residue

    Philips is recalling HeartStart Home and OnSite AEDs because solder residue may prevent the device from delivering therapy in an emergency.

    Product
    Philips HeartStart Home and OnSite (HS1) automated external defibrillators (AEDs). Product Usage: The models M5066A, M5067A, and M5068A are designed for use on a person in sudden cardiac arrest who is: -Unresponsive when shaken -Not breathing normally If in doubt, apply the
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0965-2013·2013-03-27

    Boston Scientific SQ-RX Subcutaneous Pulse Generators Recalled for Fuse Activation

    Boston Scientific is recalling SQ-RX Model 1010 subcutaneous pulse generators because an internal fuse may activate unintentionally, preventing the device from delivering therapy.

    Product
    Boston Scientific/Cameron Health SQ-RX Model 1010 subcutaneous pulse generators. The S-ICD System is intended to provide therapy for the treatment of life-threatening ventricular tachyarrhythmias.
    Category
    Medical Device
    Distribution
    17 states
  • SevereFDA (Devices)·Z-0124-2013·2012-11-07

    HeartSine Samaritan 300/300P PAD Devices Recalled for Malfunction

    Heartsine is recalling 81,982 Samaritan 300/300P PAD devices because they may turn on or off unexpectedly, potentially preventing therapy delivery during cardiac arrest.

    Product
    HeartSine Samaritan(R) 300/300P PAD devices with serial numbers 0400000501 to 0700032917; 08A00035000 to 10A0070753; 10C00200000 to 10C00210106 Product Usage: Samaritan 300/300P PAD is indicated for use on victims of sudden cardiac arrest who are exhibiting the following sign
    Category
    Medical Device
    Distribution
    Distributed nationwide