Boston Scientific Recalls Mislabeled WallFlex Biliary Stent Systems
Boston Scientific is recalling 40 units of WallFlex Biliary RX stents that were mislabeled as fully covered devices. The error involves the 10mm x 60mm size.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text describes a labeling error without reporting any injuries, illnesses, or hospitalizations, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Boston Scientific Corporation is recalling 40 units of the WallFlex Biliary RX Fully Covered Stent System RMV (10mmx60mm Stent). The recall is due to a labeling error where WallFlex Biliary RX Uncovered Stent System 10x60mm devices were incorrectly labeled as fully covered stents.
The affected products are identified by Lot code 25607019, with an expiration date of June 17, 2022, and GIN 08714729953180. These devices are indicated for the palliative treatment of biliary strictures produced by malignant neoplasms and relief of malignant biliary obstruction prior to surgery.
The recall covers US Nationwide distribution. The FDA has classified this as a Class II recall. Healthcare providers and patients should verify the labeling of their devices to ensure they are not using the mislabeled uncovered stents.
The recalled product
- Product
- WallFlexTM Biliary RX Fully Covered Stent System RMV (10mmx60mm Stent) UPN: M00570370 - Product Usage: is indicated for use in the palliative treatment of biliary strictures produced by malignant neoplasms and relief of malignant biliary obstruction prior to surgery.
- Manufacturer
- Boston Scientific Corporation
- Category
- Medical Device — Biliary Stent
- Hazard
- Affected units
- 40
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 (2)
- Lot code:25607019 Exp. Date: June 17th
- 2022 GIN:08714729953180
Distribution
Distributed nationwide across the United States.
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