Boston Scientific recalls Wallflex Esophageal Stent Systems due to potential catheter tip detachment during delivery. Affected units include specific model numbers and lot numbers listed in the recall notice.
WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.
Boston Scientific is recalling Wallflex Esophageal Stent Systems that may have a catheter tip that detaches during delivery. This could lead to serious complications if the stent becomes lodged in the esophagus.
The stent system uses a delivery catheter that could detach during insertion. If the catheter detaches, it may become lodged in the esophagus, causing injury or blockage.
Patients who have been implanted with the recalled Wallflex Esophageal Stent Systems are most at risk. Healthcare providers using the system for medical procedures may also be affected.
Check the product label for the model number M00516730 or the GTIN 08714729778066. Affected units include specific lot numbers listed in the recall notice.
Look for the model number M00516730 or GTIN 08714729778066 on the product label.
If you have the stent system, contact your healthcare provider for guidance on next steps.
The hazard is the potential for delivery catheter tip detachment during insertion, which could cause the stent to become lodged in the esophagus.
Affected lot numbers include 32770264, 32779262, 32799929, 32799930, 32809367, 32927194, 32946077, 32976902, 32977680, 32977681, 33017674, 33036450, 33036451, 33045963, 33064554, 33064555, 33085586, 33130671, 33130672, 33195044, 33195045, 33214280, 33218599, 33266647.
Contact your healthcare provider for guidance on whether you need to take action.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-3278-2024 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-3278-2024 from Boston Scientific. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
