Boston Scientific Recalls WallFlex Esophageal Stents Due to Catheter Tip Detachment
Boston Scientific is recalling WallFlex and Agile esophageal stent systems because the delivery catheter tip may detach during use.
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. The hazard involves a mechanical failure (catheter tip detachment) of a medical device used in a sensitive anatomical area, which poses a risk of harm, but the source text does not report specific injuries or fatalities.
Plain-English summary
Boston Scientific Corporation is recalling the WallFlex Esophageal Stent System and Agile Esophageal Over the Wire (OTW) Stent System. The recall is due to the potential for the delivery catheter tip to detach. The affected product is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistulas.
The recall involves 297 units of the WallFlex PC ESOPH STENT 18/23MM X 103MM. The products were distributed worldwide, including the US, APAC, Canada, EMEA, and LATAM. Specific lot numbers are listed in the agency's recall record.
Healthcare providers and patients should contact Boston Scientific or their local distributor for instructions on how to manage the recalled devices. The FDA has classified this as a Class II recall, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- WALLFLEX PC ESOPH STENT 18/23MM X 103MM- Wallflex Esophageal Partially Covered and Fully Covered Stent System is Intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent…
- Manufacturer
- Boston Scientific Corporation
- Affected units
- 297
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 (20)
- GTIN: 08714729765240 Lot Numbers: 32759902
- 32780160
- 32830094
- 32865976
- 32868557
- 32875121
- 32891029
- 32898065
- 32898066
- 32906414
- 32915745
- 32938540 32966004
- 32977682
- 32985473
- 33026702
- 33026704
- 33036452
- 33036453
- 33045964
- 33056440
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 31 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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