Carotid stent delivery systems recalled over resistance during withdrawal after deployment
Certain batches of the Carotid WALLSTENT Monorail Endoprosthesis are being removed after complaints of greater than anticipated resistance withdrawing the delivery system. The most serious potential consequence is stroke.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The rubric assigns 5 to any FDA Class I recall, and the FDA classified this stent delivery system removal as Class I.
Plain-English summary
Certain batches of the Carotid WALLSTENT Monorail Endoprosthesis, a closed cell self-expanding stent supplied with its delivery system, are being removed from the market. Affected material numbers include H7493915010240 (Carotid WALLSTENT Monorail 10.0-24) and H7493915010310 (Carotid WALLSTENT Monorail 10.0-31), with UDI-DI 08714729781097 and batch numbers listed in the recall notice. The action covers 26,570 units, of which 1,333 were distributed in the United States including Puerto Rico and 25,174 outside the United States.
The batches are being removed because of an increase in complaints in which physicians encountered greater than anticipated resistance while attempting to withdraw the stent delivery system from the guidewire or embolic protection device after successful stent deployment. The manufacturer states the most serious potential adverse health consequence is stroke, with other risks including delay to the procedure, vessel injury, vessel spasm, and stent disruption or damage requiring additional intervention. The FDA classified the action as Class I, its most serious category.
Hospitals holding affected batches should quarantine them and follow the manufacturer's instructions for return. Patients with questions about a stent already implanted should speak to their treating physician.
The recalled product
- Product
- Carotid WALLSTENT Monorail Endoprosthesis Closed Cell Self-Expanding Stent, stent and stent delivery system. Material numbers: H7493915010240 CAROTID WALLSTENT MONORAIL 10.0-24; H7493915010310 CAROTID WALLSTENT MONORAIL 10.0-31; H749391506220 CAROTID WALLSTENT…
- Manufacturer
- Boston Scientific Corporation
- Category
- Medical Device — Vascular Stent
Distribution
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