The Recall Desk

Hazard

Atrio Esophageal Fistula 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
6
Most recent
2024-11-20

Of the 7 atrio esophageal fistula recalls we have scored against our rubric, 1 (14%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 6 (86%) 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 atrio esophageal fistula 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-0303-2025·2024-11-20

    Boston Scientific POLARx Cryoablation Catheters Instructions Updated for Atrio-esophageal Fistula Risk

    Boston Scientific issued a Class I recall of POLARx and POLARx FIT Cryoablation Balloon Catheters. Instructions for use are being updated due to risk of atrio-esophageal fistula, a serious complication.

    Product
    Boston Scientific SMARTFREEZE CRYO CONSOLE: Console: Material Number M004CRBS4000; CONSOLE REFURB: Material Number M004CRBS400R0; CONSOLE HOSPITAL, Material Number M004CRBS400H0, CONSOLE ZERO, Material Number M004CRBS400Z0
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0299-2025·2024-11-20

    Cryoablation Balloon Catheter Instructions Updated for Atrio-esophageal Fistula Risk

    Boston Scientific is updating instructions for use of POLARx and POLARx FIT Cryoablation Balloon Catheters to address atrio-esophageal fistula risk. Approximately 5,913 units have been distributed worldwide.

    Product
    Boston Scientific POLARx FIT BALLOON CATHETER ST OUS, Material Number M004CRBS2010
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0300-2025·2024-11-20

    Boston Scientific POLARx FIT cryoablation catheter instructions updated for fistula risk

    Boston Scientific updated instructions for use of its POLARx and POLARx FIT cryoablation catheters, affecting 960 units distributed worldwide, in response to atrio-esophageal fistula risk.

    Product
    Boston Scientific POLARx FIT BALLOON CATHETER ST US, Material Number M004CRBS2060
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0298-2025·2024-11-20

    FDA Updates POLARx Cryoablation Catheter Instructions for Atrio-esophageal Fistula Risk

    Boston Scientific is updating instructions for POLARx and POLARx FIT cryoablation catheters to address atrio-esophageal fistula risks. The FDA classified this as a Class I recall affecting approximately 20,290 units distributed worldwide.

    Product
    Boston Scientific POLARx BALLOON CATHETER LT 28MM OUS, Material Number M004CRBS2100
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0301-2025·2024-11-20

    Boston Scientific Cryoablation Balloon Catheters Instruction Update for Fistula Risk

    Boston Scientific is updating safety instructions for POLARx cryoablation balloon catheters due to atrio-esophageal fistula risk. The update affects approximately 2,751 units distributed worldwide.

    Product
    Boston Scientific POLARx FIT BALLOON CATHETER LT OUS, Material Number M004CRBS2110
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0297-2025·2024-11-20

    Boston Scientific POLARx Cryoablation Catheters Instructions Updated for Fistula Risk

    Boston Scientific is updating instructions for POLARx and POLARx FIT cryoablation catheters to address atrio-esophageal fistula risk, a potentially serious complication from ablation procedures. FDA Class I recall affecting 4422 units worldwide.

    Product
    Boston Scientific POLARx BALLOON CATHETER ST 28MM OUS, Material Number M004CRBS2000.
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0302-2025·2024-11-20

    Boston Scientific Cryoablation Balloon Catheters Recalled for Fistula Risk

    Boston Scientific is updating instructions for POLARx and POLARx FIT cryoablation balloon catheters due to atrio-esophageal fistula risk. Affected devices were distributed worldwide.

    Product
    Boston Scientific POLARx FIT BALLOON CATHETER LT US, Material Number M004CRBS2160
    Category
    Medical Device
    Distribution
    0 states