Boston Scientific Corporation The Peripheral Cutting Balloon Device small Monorail Delivery System features a balloon with 3 or 4 atherotomes (microsurgical blades) mounted longitudinally on its outer surface. When the Peripheral Cutting Balloon device is inflated, the atherotomes score the plaque, creating initiation sites for crack propagation. Percutaneous Transluminal Angioplasty (PTA) with the Peripheral Cutting Balloon Device allows dilatation of the target lesion with less pressure. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
The Peripheral Cutting Balloon Device small Monorail Delivery System features a balloon with 3 or 4 atherotomes (microsurgical blades) mounted longitudinally on its outer surface. When the Peripheral Cutting Balloon device is inflated, the atherotomes score the plaque, creating initiation sites for crack propagation. Percutaneous Transluminal Angioplasty (PTA) with the Peripheral Cutting Balloon Device allows dilatation of the target lesion with less pressure.
Brand
Boston Scientific Corporation
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
Lot/Batch# EF0206 EF0300 EF5054 EF5062 EF5066 EF5113 EF5142 EF5187 5140F EF5188 EF5253 EFO017 EF0160 EF5069 EF5421 EF5547 EF5554
Boston Scientific Corporation is recalling The Peripheral Cutting Balloon Device small Monorail Delivery System features a balloon with 3 or 4 due to The distal shaft of the catheter may separate during withdrawal of the device from the patient. If the shaft separates, the surgical procedure may be . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The distal shaft of the catheter may separate during withdrawal of the device from the patient. If the shaft separates, the surgical procedure may be prolonged or require more in-depth surgery to physically remove the broken-off shaft from the blood vessel.
Recommended Action
Per FDA guidance
All affected direct accounts will be given notification by Overnight mail. A 100% of the total number of customer are to be contacted.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026