Venous stents recalled over a nitinol anomaly that reduces deployed diameter
Medtronic is recalling 442 Abre Venous Self-Expanding Stent Systems because a nitinol anomaly causes a reduced stent diameter and radial force when deployed, which may result in migration.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Scored 3 under the risk-of-harm criterion: the firm states the anomaly may result in stent migration, and no injuries are reported.
Plain-English summary
The Abre Venous Self-Expanding Stent System is being recalled by Medtronic Inc, across the model numbers listed in the enforcement record including AB9G14120090, AB9G12100090, AB9G14080090 and AB9U12060090.
The record states that stents may be impacted by a nitinol anomaly which causes a reduced stent diameter when deployed and a corresponding reduced radial force, and that the issue may result in stent migration.
The record lists 442 units, with UDI-DI GTINs including 00763000547332, 00763000547271 and 00763000547318. Distribution was worldwide, including nationwide in the United States and to Argentina, Australia, Austria, Belgium, Chile, Colombia and Costa Rica among other countries. The FDA has classified the action as Class II.
The enforcement record reports no injuries. Facilities should quarantine affected stock and follow Medtronic's instructions.
The recalled product
- Product
- Abre Venous Self-Expanding Stent System, Model numbers AB9G14120090 AB9G12100090 AB9G14080090 AB9G12080090 AB9U12060090 AB9U14100090 AB9U14080090 AB9U12080090 AB9U14060090 AB9G14100090 AB9G12060090
- Manufacturer
- Medtronic Inc
- Category
- Medical Device — Vascular stent
- Affected units
- 442
Distribution
Distributed nationwide across the United States.
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