Boston Scientific Recalls Coyote Balloon Dilation Catheters Due to Deflation Issues
Boston Scientific is recalling specific lots of Coyote balloon dilation catheters because the balloons may not deflate as expected during procedures.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk-of-harm product where the device may not function as intended during a procedure, but no injuries or illnesses have been reported.
Plain-English summary
Boston Scientific Corporation is initiating a recall for one lot of the Coyote OVER-THE-WIRE PTA Balloon Dilation Catheter and one lot of the Coyote MONORAIL PTA Balloon Dilation Catheter. The recall involves 35 units of these medical devices.
The recall was initiated because Boston Scientific became aware that the balloons of the devices from these lots may not deflate as expected during a procedure. To date, the company has received three complaints regarding this specific issue.
The affected products were distributed in the United States to Alabama, California, Florida, Illinois, Indiana, Michigan, Missouri, New York, Ohio, Pennsylvania, and Texas. They were also distributed internationally to Italy, Germany, France, Great Britain, the Netherlands, White Russia, India, and Japan. Healthcare providers should stop using the affected lots and contact Boston Scientific for further instructions.
The recalled product
- Product
- Boston Scientific, 2.5mm Coyote" OVER-THE-WIRE PTA Balloon Dilation Catheter, UPN# H74939186251210, Catalog # 39186-25121.
- Manufacturer
- Boston Scientific Corporation
- Category
- Medical Device — Cardiovascular
- Hazard
- Affected units
- 35
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)
- 16397693
Distribution
Part of a larger recall action
This product is one of 2 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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