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.
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 recall of a medical device involving risk of a serious complication (atrio-esophageal fistula). Per the rubric, FDA Class I recalls are never scored below 4 regardless of reported injury status.
Plain-English summary
Boston Scientific issued an FDA Class I recall affecting 960 units of its POLARx and POLARx FIT Cryoablation Balloon Catheters (Material Number M004CRBS2060, GTIN 08714729992622). The company updated the product instructions for use to address the risk of atrio-esophageal fistula, a serious complication where an abnormal connection can develop between the heart and esophagus.
These catheters were distributed worldwide. The recall notice does not specify the distribution dates or affected lot numbers beyond the material number and GTIN provided. No illnesses or injuries have been reported as of the recall announcement.
Patients and healthcare providers should contact Boston Scientific or their healthcare provider for the updated instructions for use and guidance on managing this risk.
The recalled product
- Product
- Boston Scientific POLARx FIT BALLOON CATHETER ST US, Material Number M004CRBS2060
- Manufacturer
- Boston Scientific Corporation
- Hazard
- Affected units
- 960
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 08714729992622
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 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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