Boston Scientific esophageal stent systems recalled for catheter tip detachment
Boston Scientific is recalling Wallflex and Agile esophageal stent systems due to potential delivery catheter tip detachment during stent placement procedures.
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: This is an FDA Class II recall involving potential device malfunction with no reported injuries or hospitalizations. The hazard is theoretical—a risk-of-harm scenario where injury has not yet been reported. Per the severity rubric, such products score 3 (High).
Plain-English summary
Boston Scientific Corporation is recalling Wallflex Esophageal Stent Systems and Agile Esophageal Over-the-Wire (OTW) Stent Systems. These devices maintain esophageal patency in patients with esophageal strictures caused by intrinsic or extrinsic malignant tumors, or occlusion of esophageal fistulas.
The recall is due to the potential for delivery catheter tip detachment. During the stent placement procedure, the catheter tip may detach.
Affected units include 507 devices distributed worldwide, including in the United States, Asia-Pacific, Canada, Europe/Middle East/Africa, and Latin America. Specific lot numbers have been identified.
The recalled product
- Product
- WALLFLEX ESOPHAGEAL FC 23/28MMX12CM- 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 esophageal
- 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 (20)
- GTIN: 08714729778073 Lot Numbers: 32771050
- 32771051
- 32789719
- 32790020
- 32827713
- 32837013
- 32837014
- 32846903
- 32856378
- 32875122
- 32876614
- 32888839 32906418
- 32914770
- 32919349
- 32927196
- 32928279
- 32938993
- 33014831
- 33038108
- 33101459
Distribution
Distributed nationwide across the United States.
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