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.
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. 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…
- 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.
See all 2 products in this recall →Related recalls
Same manufacturer · Boston Scientific Corporation
See all →- SevereBoston Scientific Recalls Imager II Angiographic Catheters Due to Tip Fracture Risk
FDA (Devices) · 2026-09-30
- ModerateBoston Scientific StoneSmart Connect Console Power Adapter Recall
FDA (Devices) · 2026-09-23
- HighBoston Scientific Recalls LUX-Dx Insertable Cardiac Monitor Server Software
FDA (Devices) · 2026-09-09
- HighBoston Scientific Recalls LUX-Dx Insertable Cardiac Monitor Server Software
FDA (Devices) · 2026-09-09
- HighBoston Scientific Recalls LUX-Dx Insertable Cardiac Monitor Server Software
FDA (Devices) · 2026-09-09
Same hazard · mechanical failure
See all →- SevereCanon Medical Alphenix INFX-8000C/B5 Recalled for Tabletop Shift Risk
FDA (Devices) · 2026-10-14
- ModerateLeMaitre TufTex Over-the-Wire Embolectomy Catheter Recalled for Balloon Failure
FDA (Devices) · 2026-10-14
- HighMirion Captus 4000e Thyroid Uptake System Recalled for Spring Arm Failure
FDA (Devices) · 2026-09-23
- HighIMRIS ORT200 Operating Room Table Recalled for Mechanical Failure Risk
FDA (Devices) · 2026-09-02
- HighIMRIS ORT300 Operating Room Table Recalled for Mechanical Failure Risk
FDA (Devices) · 2026-09-02
Similar recalls
- HighBoston Scientific Hydratome RX Devices Recalled Due to Sterile Barrier Breach
FDA (Devices) · 2022-03-23
- HighBoston Scientific DREAMTOME Medical Device Recalled for Sterile Barrier Breach
FDA (Devices) · 2022-03-23
- ModerateBoston Scientific Recalls Extractor Pro RX Retrieval Balloon Catheter Due to Labeling Error
FDA (Devices) · 2015-07-08
- HighBoston Scientific Recalls NephroMax Balloon Catheter Kits Due to Packaging Error
FDA (Devices) · 2013-07-17
- HighBoston Scientific Sphincterotome Device Recalled Due to Sterile Barrier Breach
FDA (Devices) · 2022-03-23
- HighBoston Scientific Recalls Coyote Balloon Dilation Catheters Due to Deflation Issues
FDA (Devices) · 2014-02-19