Boston Scientific Recalls Small Peripheral Cutting Balloon Catheters
Boston Scientific is recalling 4.0mm x 15mm Small Peripheral Cutting Balloon catheters because users may be unable to remove the protector cap from the device.
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 2/5 (Moderate).
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, and the hazard involves a functional defect (difficulty removing a cap) without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary 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 1,331 units distributed worldwide, including the United States and numerous international markets.
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. The devices are indicated for Percutaneous Transluminal Angioplasty (PTA) of obstructive lesions of synthetic or native arteriovenous dialysis fistulae.
Healthcare providers and facilities that have received these specific devices should stop using them and contact Boston Scientific for instructions on removal or replacement. The recall covers specific lot numbers and catalog numbers for the 4.0mm x 15mm Monorail and Over-the-Wire models.
The recalled product
- Product
- Boston Scientific, Small Peripheral Cutting BalloonTM, Sterilized using irradiation: The Peripheral Cutting Balloon Catheters are indicated for Percutaneous Transluminal Angioplasty (PTA) of obstructive lesions of synthetic or native arteriovenous dialysis fistulae. 1)…
- Manufacturer
- Boston Scientific Corporation
- Category
- Medical Device — Cardiovascular
- Hazard
- Affected units
- 1,331
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 (20)
- UPN # 001BPM4015140F0
- Catalogue #BPM4015140F. Lot#'s 15778169
- 15735527
- 15774378
- 15788826
- 15812347
- 15824636
- 15825277
- 15836626
- 15873338
- 15891705
- 15931291
- 15945240
- 16057260. UPN# M001PCBM4015140F0
- Catalogue #PCBM4015140F
- Lot #15756145. UPN # M001PCBO4015140F0
- Catalogue #PCBO4015140F
- Lot #'s 15688199
- 15992736
- 16066536
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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