The FDA issued a notice outlining a serious recall of the Boston Scientific carotid WallStent monorail endoprosthesis.
According to the FDA, the device may cause serious injury or death with continued use, making it the most serious type of recall. Boston Scientific instructed users to immediately stop using affected devices and remove them from inventory. Customers should clearly segregate the devices and return them to the company.
The carotid WallStent monorail endoprosthesis, a self-expanding stent, is used to open narrowed carotid arteries. Users place the device using a catheter over a guidewire or embolic protection device.
On July 7, the company issued a letter to customers outlining a manufacturing defect with the endoprosthesis. The company said the defect created an inner lumen smaller than specifications, causing resistance when withdrawing the stent delivery system.
Using the affected stent systems could cause serious harm. That may include injury to the blood vessel, damage to the stent or release of debris that could travel to the brain and cause stroke. As of July 29, Boston Scientific reports six cases that required additional intervention to recover the device. It has not reported any deaths associated with the issue. according to the FDA notice.
Affected device lots:
| 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 |
