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.
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: 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
- Affected units
- 5,913
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.
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
- 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
- CriticalBoston Scientific POLARx Cryoablation Catheters Instructions Updated for Atrio-esophageal Fistula Risk
FDA (Devices) · 2024-11-20
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