Boston Scientific Recalls Innova Self-Expanding Stent Systems Due to Release Defect
Boston Scientific is recalling 22,916 Innova Self-Expanding Stent Systems because they may not fully release from the delivery system.
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: The recall is classified as FDA Class II, and the hazard involves a medical device that may fail to deploy correctly, posing a risk of harm to patients, although no specific injuries or illnesses are reported in the source text.
Plain-English summary
Boston Scientific Corporation is recalling 22,916 units of the Innova Self-Expanding Stent System, 180mm. The recall was initiated because the stent may be unable to be fully released from the delivery system.
The affected products are indicated to improve luminal diameter in the treatment of symptomatic de-novo or restenotic lesions in the native superficial femoral artery (SFA) and/or proximal popliteal artery (PPA). The recall covers various material numbers and batch numbers, including Innova-EU, Innova-China, and Innova variants with specific diameter and length configurations.
The products were distributed worldwide, including nationwide in the United States and internationally to Canada. Patients who have received these stents should contact their healthcare provider for evaluation and appropriate management.
The recalled product
- Product
- Innova Self-Expanding Stent System, 180mm. Labeled with Material Number and description as follows: Product Usage: The Innova Vascular Self-Expanding Stent System is indicated to improve luminal diameter in the treatment of symptomatic de-novo or restenotic lesions in the…
- Manufacturer
- Boston Scientific Corporation
- Category
- Medical Device — Vascular Stent
- Affected units
- 22,916
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- d. Innova-EU 8 x 180 x 75 (Batch No. 17520931 18628352 20818435)
- l. Innova-China 8 x 180 x 130 (Batch No. 17456013 17823505 21130830)
- m. Innova-China 8 x 180 x 75 (Batch No. 19491836)
- n. Innova 5 x 180 x 130 (Batch No. 18558414)
- o. Innova 5 x 180 x 75 (Batch No. 18583366 18611575 18754514)
Distribution
Part of a larger recall action
This product is one of 2 recalled by Boston Scientific Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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