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.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I medical device recall. Per the rubric, Class I recalls score minimum 4 (Severe) unless there are reported deaths or serious injuries. No such reports are documented in the source; therefore the score is 4 (Severe) rather than Critical.
Plain-English summary
Boston Scientific is updating the instructions for use of its POLARx and POLARx FIT Cryoablation Balloon Catheters related to atrio-esophageal fistula risk.
Atrio-esophageal fistula is a complication in which an abnormal connection forms between the heart's atrium and the esophagus. This complication can occur during cardiac procedures utilizing these cryoablation catheters.
The affected product is the Boston Scientific POLARx FIT Balloon Catheter, Material Number M004CRBS2010. Approximately 5,913 units of this medical device have been distributed worldwide.
The FDA has classified this as a Class I medical device recall.
The recalled product
- Product
- Boston Scientific POLARx FIT BALLOON CATHETER ST OUS, Material Number M004CRBS2010
- 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 08714729992578
Distribution
Distribution scope not specified by the agency.
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