This recall involves removing certain devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it.
Affected Product
| Product Name | Lot Number | UDI-DI (GTIN) |
|---|---|---|
| CAROTID WALLSTENT MONORAIL 10.0-24 | H7493915010240 | 08714729781097 |
| CAROTID WALLSTENT MONORAIL 10.0-31 | H7493915010310 | 08714729781110 |
| CAROTID WALLSTENT MONORAIL 6.0-22 | H749391506220 | 08714729781158 |
| CAROTID WALLSTENT MONORAIL 8.0-21 | H749391508210 | 08714729781172 |
| CAROTID WALLSTENT MONORAIL 8.0-29 | H749391508290 | 08714729781196 |
| CAROTID WALLSTENT MONORAIL 6.0-22 | H965SCH647010 | 08714729263869 |
| CAROTID WALLSTENT MONORAIL 8.0-21 | H965SCH647070 | 08714729263876 |
| CAROTID WALLSTENT MONORAIL 8.0-29 | H965SCH647080 | 08714729263883 |
| CAROTID WALLSTENT MONORAIL 8.0-36 | H965SCH647090 | 08714729263890 |
| CAROTID WALLSTENT MONORAIL 10.0-24 | H965SCH647120 | 08714729263906 |
| CAROTID WALLSTENT MONORAIL 10.0-31 | H965SCH647130 | 08714729263913 |
What to Do
On July 7, 2025, Boston Scientific sent all affected customers an Urgent Medical Device Removal Letter recommending the following actions:
- Immediately stop using affected devices.
- Remove affected devices from inventory, clearly segregate, and return to Boston Scientific.
- Complete and return the Reply Verification Tracking Form, even if no affected devices remain.
- Share this information with all staff, facilities, and customers who may have received the product.
Reason for Recall
Boston Scientific is recalling the Carotid WALLSTENT Monorail Endoprosthesis due to a manufacturing defect that created an inner lumen smaller than specifications, causing resistance when withdrawing the stent delivery system.
Using the affected stent systems could cause serious harm, such as injury to the blood vessel, damage to the stent or release of debris that could travel to the brain and cause a stroke.
As of July 29, 2025, Boston Scientific has reported six cases that required additional intervention to recover the device. Boston Scientific has not reported any deaths associated with this issue.
Device Use
The Carotid WALLSTENT Monorail Endoprosthesis is a self-expanding stent used to open narrowed carotid arteries and is placed using a catheter over a guidewire or embolic protection device.
Contact Information
Customers in the U.S. with adverse reactions, quality problems, or questions about this recall should contact Boston Scientific at BSCFieldActionCenter@bsci.com or 1-763-415-7700.
Unique Device Identifier (UDI)
The unique device identifier (UDI) helps identify individual medical devices sold in the United States from manufacturing through distribution to patient use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified, and problems potentially corrected more quickly.
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.
