FDA announces new recall of self-expanding stents due to risk of ‘serious harm’
The U.S Food and Drug Administration (FDA) has announced that Boston Scientific is recalling certain self-expanding stents due to a significant defect that can cause resistance when the stent delivery system is withdrawn. If resistance does occur, it can put the patient’s health at risk.
The recall includes a total of more than 26,000 of Boston Scientific’s Carotid Wallstent Monorail Endoprosthesis devices. These vascular stents are used to open a patient’s narrowed carotid arteries and are placed using a catheter over a guidewire or embolic protection device.
The FDA has ruled this a Class I recall, which means “this device may cause serious injury or death if you continue to use it.”
“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,” according to the FDA’s advisory.
Boston Scientific has received reports of six cases that required additional treatment due to this defect. There have been no reports of patient deaths.
An example of the defect found in Boston Scientific's Carotid Wallstent Monorail Endoprosthesis devices. Image courtesy of the FDA.
Wallstent devices should be returned to the manufacturer
Boston Scientific first reached out to customers about this issue in early July with an Urgent Medical Device Removal Letter. The company has urged customers to stop using these devices immediately. In addition, any affected devices still on hand should be removed from the customer’s inventory and returned to Boston Scientific.
Specific devices covered by this recall include:
- CAROTID WALLSTENT MONORAIL 10.0-24
- CAROTID WALLSTENT MONORAIL 10.0-31
- CAROTID WALLSTENT MONORAIL 6.0-22
- CAROTID WALLSTENT MONORAIL 8.0-21
- CAROTID WALLSTENT MONORAIL 8.0-29
- CAROTID WALLSTENT MONORAIL 6.0-22
- CAROTID WALLSTENT MONORAIL 8.0-21
- CAROTID WALLSTENT MONORAIL 8.0-29
- CAROTID WALLSTENT MONORAIL 8.0-36
- CAROTID WALLSTENT MONORAIL 10.0-24
- CAROTID WALLSTENT MONORAIL 10.0-31
Click here for additional information from the FDA’s medical device recall database.
Michael has more than 19 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.