Boston Scientific Recalls Coyote PTA Balloon Dilatation Catheters
Boston Scientific is recalling Coyote PTA Balloon Dilatation 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 involves a medical device with a functional defect (balloons not deflating) that poses a risk of harm during a procedure, but the source text does not report any injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Boston Scientific Corporation is initiating a recall of one lot of the Coyote OVER-THE-WIRE PTA Balloon Dilatation Catheter and one lot of the Coyote MONORAIL PTA Balloon Dilatation Catheter. The recall involves 35 units of these devices.
The recall was initiated because the balloons of the devices from these lots may not deflate as expected during a procedure. Boston Scientific has received three complaints regarding this specific issue.
The affected devices were distributed in the United States (AL, CA, FL, IL, IN, MI, MO, NY, OH, PA, TX) and internationally (Italy, Germany, France, Great Britain, Netherlands, White Russia, India, Japan). Healthcare providers should stop using the affected lots and contact Boston Scientific for instructions on return or replacement.
The recalled product
- Product
- Boston Scientific, Coyote" MONORAIL" PTA Balloon Dilatation Catheter, UPN # H74939185201510, Catalogue # 39185-20151.
- 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)
- 16310947
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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