Boston Scientific recalls WallFlex FC ESO stents due to potential catheter tip detachment during esophageal stent placement. Affected units have specific lot numbers and material codes. Contact for return instructions.
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 FC ESO stents that may detach the delivery catheter tip during use, risking serious injury. This recall affects specific lot numbers and material codes used in esophageal stent procedures.
The delivery catheter tip could detach during stent placement, potentially causing injury to the esophagus. This risk occurs when the stent is inserted through the esophagus to treat strictures caused by tumors or fistulas.
Patients who received the WallFlex FC ESO stent with lot numbers 32771052 or 32846: 32846905 or material number M00516300 are most at risk. Healthcare providers using these stents for esophageal strictures should stop using them immediately.
Check for lot numbers 32771052 or 32846905 on the stent packaging, or material number M00516300. The stent is intended for esophageal strictures and is used in medical procedures to maintain esophageal patency.
Immediately stop using the WallFlex FC ESO stent with lot numbers 32771052 or 32846905 or material number M00516300.
The recalled stent is the WallFlex FC ESO stent with material number M00516300 and lot numbers 32771052 or 32846905.
The delivery catheter tip could detach during stent placement, potentially causing injury to the esophagus.
Check for lot numbers 32771052 or 32846905 on the stent packaging or material number M00516300.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-3272-2024 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-3272-2024 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
