Boston Scientific Recalls 4.0mm Flextome Cutting Balloon Devices
Boston Scientific is recalling 4.0mm x 15mm Flextome Cutting Balloon devices because users may be unable to remove the protector cap.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a mechanical usability issue (difficulty removing a cap) without reported injuries or deaths, fitting the criteria for a moderate severity recall.
Plain-English summary
Boston Scientific Corporation is initiating a recall of the 4.0mm x 15mm size of Small Peripheral Cutting Balloon (Monorail and Over-the-Wire) Microsurgical Dilatation Devices and Flextome Cutting Balloon (Monorail and Over-the-Wire) Microsurgical Dilation Devices. The recall involves 340 units distributed worldwide, including the United States and numerous international locations.
The recall was initiated because Boston Scientific determined that users may experience significant difficulty or an inability to remove the protector cap from the device. This issue could potentially impact the usability of the device during microsurgical procedures.
Healthcare providers and facilities that have received these specific devices should stop using them and contact Boston Scientific for further instructions on the recall process.
The recalled product
- Product
- Boston Scientific, FlextomeTM Cutting BalloonTM, Sterilized using irradiation: 1) 4.00mm x 15mm FlextomeTM Cutting BalloonTM MonorailTM Microsurgical Dilatation Device, UPN #H749CBM3400150 Catalogue # CBM340015 & UPN# H749RB4400150 Catalogue # RB440015 2) 4.00mm x 15mm F
- Manufacturer
- Boston Scientific Corporation
- Affected units
- 340
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)
- 15898645
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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