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.
What this means for you
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 esoph
- Manufacturer
- Boston Scientific Corporation
- Hazard
- catheter-tip-detachment
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.
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