The Recall Desk

Hazard

Unintended Ablation recalls

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

What the numbers show

Total
6
Critical
0
Severe
3
Most recent
2021-11-17

Of the 6 unintended ablation recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 3 (50%) 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 unintended ablation 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.

1–6 of 6

  • HighFDA (Devices)·Z-0210-2022·2021-11-17

    Covidien Emprint Ablation Catheter temperature monitoring defect

    Covidien is recalling the Emprint Ablation Catheter due to a defect in temperature monitoring circuitry. If the cooling system fails during use, the device tip could overheat, causing tissue burns, unintended ablation, and allergic reactions.

    Product
    Covidien Emprint Ablation Catheter with Thermosphere Technology Bronchoscopic Ablation, CFN CA108L1
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0058-2018·2017-11-08

    Biosense Webster Recalls THERMOCOOL SF NAV Catheters Due to Display Error

    Biosense Webster is recalling THERMOCOOL SF NAV catheters because a system alert may cause physicians to ablate in unintended areas.

    Product
    THERMOCOOL SF NAV Catheters Model Numbers - BNI35FJCT, BNI35DFCT, D-131503-S, D-131504-S
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0057-2018·2017-11-08

    Biosense Webster Recalls THERMOCOOL Catheters Due to Navigation System Alert

    Biosense Webster is recalling 19 THERMOCOOL catheters because they trigger a false magnetic distortion alert on the CARTO 3 System, potentially leading to unintended ablation.

    Product
    THERMOCOOL SMARTTOUCH Uni-Directional Navigation Catheter (D133602S)
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0056-2018·2017-11-08

    Biosense Webster Recalls THERMOCOOL SMARTTOUCH Navigation Catheters

    Biosense Webster is recalling 64 THERMOCOOL SMARTTOUCH catheters because they may trigger a false magnetic distortion alert on the CARTO 3 System, potentially leading to unintended ablation.

    Product
    THERMOCOOL SMARTTOUCH Bi-Directional Navigation Catheter (D-132704-S, D-132705-S)
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0054-2018·2017-11-08

    Biosense Webster Recalls THERMOCOOL Catheters Due to System Alert Error

    Biosense Webster is recalling THERMOCOOL catheters because they may trigger a false magnetic distortion alert on the CARTO 3 System, potentially leading to unintended ablation.

    Product
    THERMOCOOL SMARTTOUCH SF Uni-Directional Product Codes D-1347-01-S, D-1347-02-S, D-1347-03-S
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0055-2018·2017-11-08

    Biosense Webster Recalls THERMOCOOL Catheters Due to Magnetic Distortion Alert

    Biosense Webster is recalling THERMOCOOL catheters because they may trigger a false magnetic distortion alert on the CARTO 3 System, potentially leading to unintended ablation.

    Product
    THERMOCOOL SMARTTOUCH SF Bi-Directional Product Codes D-1348-01-S, D-1348-04-S, D-1348-05-S
    Category
    Medical Device
    Distribution
    0 states