Boston Scientific recalls WallFlex FC ESO stent systems due to potential catheter tip detachment during esophageal stent placement. 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 FC ESO stent systems that may have a catheter tip that detaches during use, potentially causing serious injury. This recall affects specific model numbers and lot numbers listed in the notice.
The stent system may cause the delivery catheter tip to detach during insertion, which could lead to complications such as esophageal injury or blockage. This risk occurs when the stent is being placed in the esophagus to treat strictures or fistulas.
Patients with esophageal strictures or fistulas who have received the WallFlex FC ESO stent system are affected. Those who have the specific model numbers and lot numbers listed in the recall are most at risk.
Check for the model number M00516310 and lot numbers 32858862, 32865977, 32898069, 32914769, 32985474, or 33256092 on the product packaging. The stent system is intended for use in esophageal strictures or fistulas caused by tumors.
Verify the model number and lot numbers listed in the recall notice to confirm if your stent system is affected.
The recall is due to the potential for delivery catheter tip detachment during stent placement, which could cause esophageal injury.
Affected model number is M00516310 with lot numbers 32858862, 32865977, 32898069, 32914769, 32985474, and 33256092.
The recall does not require immediate discontinuation; however, affected units should be checked and contacted for further instructions.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-3273-2024 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-3273-2024 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.
