Angioplasty balloon catheters recalled over inflation and deflation difficulty
Boston Scientific is recalling 21 Coyote over-the-wire PTA balloon dilatation catheters over the potential for inflation and deflation difficulty during use in the peripheral vasculature.
What this means for you
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: Scored 3 under the risk-of-harm criterion: a balloon catheter that may not inflate or deflate properly inside the vasculature is a risk of harm, and no injuries are reported.
Plain-English summary
The Boston Scientific Coyote Over-The-Wire PTA Balloon Dilation Catheter, 4F, in 2.5mm x 120mm (REF H74939186251210) and 3.5mm x 120mm (REF H74939186351210) at 150 cm, is being recalled.
Boston Scientific is removing certain batches due to the potential for inflation and deflation difficulty during use in the peripheral vasculature. An internal investigation found that a manufacturing process variation resulted in catheters that may not properly inflate or deflate.
The record lists 21 units, with GTIN 08714729796527 and batch 37370117 expiring 3-Sept-28 for the 2.5mm size, and GTIN 08714729796756 for the 3.5mm size. Distribution was nationwide in the United States, in Massachusetts, West Virginia, Ohio, California, Minnesota, New York, Virginia, Illinois, Texas and Florida. The FDA has classified the action as Class II.
The enforcement record reports no injuries. Facilities should quarantine affected batches and follow Boston Scientific's instructions.
The recalled product
- Product
- Boston Scientific Coyote OVER-THE-WIRE PTA Balloon Dilation Catheter, 4F, 1) 2.5mm x120mm, 150 cm, UPM/Model No. REF H74939186251210; 2) 3.5mm x120mm, 150 cm, UPM/Model No. REF H74939186351210; Catheter, Angioplasty, Peripheral, Transluminal
- Manufacturer
- Boston Scientific Corporation
- Affected units
- 21
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 (6)
- 1) GTIN 08714729796527
- Batch Number 37370117
- exp. 3-Sept-28
- 2) GTIN 08714729796756
- Batch Number 37416646
- exp. 9-Sept-28
Distribution
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