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.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class I recall, which establishes a minimum severity score of 4. No reported illnesses or deaths are documented in the source; the hazard is a documented risk requiring an update to instructions for use.
Plain-English summary
Boston Scientific is updating the instructions for use of POLARx and POLARx FIT cryoablation balloon catheters due to a risk of atrio-esophageal fistula. This is a potentially serious complication where an abnormal connection may form between the heart's atrium and the esophagus during cardiac ablation procedures.
The specific product listed includes material number M004CRBS2000 (GTIN 08714729992561), with 4422 units distributed worldwide. This is an FDA Class I recall.
Healthcare providers using these devices should review the updated instructions for use to understand the fistula risk and proper precautions. Patients and healthcare professionals should consult with their care team regarding the appropriate use of these devices in clinical settings.
The recalled product
- Product
- Boston Scientific POLARx BALLOON CATHETER ST 28MM OUS, Material Number M004CRBS2000.
- Manufacturer
- Boston Scientific Corporation
- Hazard
- Affected units
- 4,422
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 (1)
- GTIN 08714729992561
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 7 recalled by Boston Scientific Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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Same hazard · atrio esophageal fistula
See all →- SevereFDA Updates POLARx Cryoablation Catheter Instructions for Atrio-esophageal Fistula Risk
FDA (Devices) · 2024-11-20
- SevereCryoablation Balloon Catheter Instructions Updated for Atrio-esophageal Fistula Risk
FDA (Devices) · 2024-11-20
- SevereBoston Scientific POLARx FIT cryoablation catheter instructions updated for fistula risk
FDA (Devices) · 2024-11-20
- SevereBoston Scientific Cryoablation Balloon Catheters Recalled for Fistula Risk
FDA (Devices) · 2024-11-20
- SevereBoston Scientific Cryoablation Balloon Catheters Instruction Update for Fistula Risk
FDA (Devices) · 2024-11-20
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