FDA Recalls Esophageal Stent Systems for Potential Catheter Tip Detachment
Boston Scientific's Wallflex and Agile esophageal stent systems are recalled due to the potential for delivery catheter tip detachment. The recall affects 146 units distributed worldwide.
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: FDA Class II medical device with potential for delivery catheter tip detachment. This is categorized as a risk-of-harm product where injury has not yet been reported, according to the severity rubric criteria for High severity.
Plain-English summary
Boston Scientific Corporation has recalled its Wallflex Esophageal Partially Covered and Fully Covered Stent System and Agile Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.
These stents are designed to maintain esophageal patency in patients with esophageal strictures caused by malignant tumors or esophageal fistulas. The recalled devices include Material Number M00516240 (GTIN 08714729854500) in lot numbers 32867087, 32980849, 33014126, 33085585, 33128875, 33208047, 33233490, and 33275533.
The recall affects 146 units that have been distributed worldwide, including throughout the United States and in APAC, Canada, EMEA, and LATAM regions. Healthcare providers should contact Boston Scientific Corporation for guidance on appropriate actions regarding recalled devices currently in use or inventory.
The recalled product
- Product
- WALLFLEX FC ESO STENT RMV 23X105MM- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System 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
- Hazard
- Affected units
- 146
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 (8)
- GTIN: 08714729854500 Lot Numbers: 32867087
- 32980849
- 33014126
- 33085585
- 33128875
- 33208047
- 33233490
- 33275533
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.
See all 31 products in this recall →Related recalls
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Same hazard · catheter tip detachment
See all →- HighBoston Scientific Agile Esophageal Over-the-Wire Stent System recalled for catheter tip detachment
FDA (Devices) · 2024-10-02
- HighEsophageal Stent Systems Recalled Due to Catheter Detachment Risk
FDA (Devices) · 2024-10-02
- HighBoston Scientific Esophageal Stents Recalled for Delivery Catheter Tip Detachment
FDA (Devices) · 2024-10-02
- HighBoston Scientific esophageal stents recalled due to catheter tip detachment risk
FDA (Devices) · 2024-10-02
- HighWallFlex and Agile esophageal stent systems recalled for delivery catheter tip detachment
FDA (Devices) · 2024-10-02
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