Boston Scientific Recalls Mislabeled Ultraflex Tracheobronchial Stents
Boston Scientific is recalling four Ultraflex Tracheobronchial stents because 10mm diameter units were mislabeled as 12mm diameter.
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 and involves a minor labeling error regarding device dimensions, which fits the criteria for moderate severity.
Plain-English summary
Boston Scientific Corporation is recalling four units of the Ultraflex Tracheobronchial Distal Release Stent System. The specific units involved are 12mm x 30mm stents with Material Number M00576550 and Lot Number 18876596. The recall is due to a labeling error where 10mm diameter x 30mm length stents were incorrectly labeled as 12mm diameter x 30mm.
The affected products were distributed nationwide to Alabama, California, Massachusetts, and Texas. The stent system is a permanently implanted expandable metal stent designed for the palliation of tracheobronchial strictures. The expiration date for the affected lot is February 1, 2018.
Healthcare providers and patients should verify the diameter of the implanted stent against the original packaging and device documentation. If a 10mm stent was implanted based on a 12mm label, providers should contact Boston Scientific for further instructions.
The recalled product
- Product
- Boston Scientific Ultraflex Tracheobronchial Distal Release Stent System 12mm X 30mm Material Number: M00576550 The stent system is a permanently implanted expandable metal stent designed for palliation of tracheobronchial (TB) strictures. The system consists of a flexible…
- Manufacturer
- Boston Scientific Corporation
- Hazard
- Affected units
- 4
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 Number: 18876596 Exp Date: February 1
- 201 8
Distribution
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