FDA Recalls Esophageal Stent Systems Due to Delivery Catheter Tip Detachment Risk
Boston Scientific recalled 364 esophageal stent systems due to potential delivery catheter tip detachment during placement procedures. No injuries have been reported. Affected patients and providers should contact the manufacturer.
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 a risk-of-harm medical device with potential for delivery system failure. While no injuries or illnesses have been reported, the potential for catheter tip detachment during esophageal stent placement constitutes a significant risk scenario. Per the rubric, theoretical hazards without reported injuries score at most 3.
Plain-English summary
Boston Scientific Corporation has recalled 364 units of WallFlex Esophageal Stent Systems and Agile Esophageal Over-the-Wire Stent Systems used to maintain esophageal patency in patients with esophageal strictures caused by malignant tumors and esophageal fistulas.
The recall was issued due to the potential for delivery catheter tip detachment during the stent placement procedure. The delivery catheter may detach at the tip during insertion, which could affect proper stent placement.
The recalled units were distributed worldwide, including the United States, Asia-Pacific, Canada, Europe/Middle East/Africa, and Latin America. Patients with implanted stents and healthcare facilities with unused devices from the affected lot numbers should contact Boston Scientific Corporation for further instructions. The FDA has classified this as a Class II recall and assigned it recall number Z-3278-2024.
The recalled product
- Product
- WALLFLEX ESOPHAGEAL FC 23/28MMX10CM- 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
- Affected units
- 364
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: 08714729778066 Lot Numbers: 32770264
- 32779262
- 32799929
- 32799930
- 32809367
- 32927194
- 32946077
- 32976902
- 32977680
- 32977681
- 33017674
- 33036450 33036451
- 33045963
- 33064554
- 33064555
- 33085586
- 33130671
- 33130672
- 33195044
- 33195045
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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