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.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.
Our severity reasoning: FDA Class I medical device recall. Per the severity rubric, FDA Class I recalls are classified as Critical due to reasonable probability of serious adverse health consequences. The hazard—atrio-esophageal fistula—is a life-threatening complication.
Plain-English summary
This is a Class I recall issued by the FDA regarding the instructions for use of Boston Scientific's POLARx and POLARx FIT Cryoablation Balloon Catheters. The recall involves 1,035 units distributed worldwide.
The recall addresses a risk of atrio-esophageal fistula, a serious medical complication. An atrio-esophageal fistula is an abnormal connection that may develop between the heart's atrium and the esophagus, potentially leading to infection and serious health consequences.
Healthcare facilities and practitioners using these cryoablation balloon catheters should review the updated instructions for use issued by Boston Scientific. Patients who have undergone or may undergo procedures with these catheters are advised to consult their healthcare providers with any concerns regarding this risk.
The recalled product
- 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
- Manufacturer
- Boston Scientific Corporation
- Hazard
- atrio-esophageal-fistula
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 08714729992691
Distribution
Distribution scope not specified by the agency.
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