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, potentially causing injury. This recall affects specific model numbers and lot numbers listed in the notice.
The stent system's delivery catheter tip could detach during insertion, leading to potential injury to the esophagus. This risk occurs when the stent is being placed in the esophagus for medical treatment.
Patients with esophageal strictures or fistulas who have received the recalled WallFlex stent systems are most at risk. Healthcare providers using the systems for medical procedures may also be affected.
Check the product label for the model number M00516750 and lot numbers listed in the recall notice, such as 32809369, 32809370, and others. The stent system is intended for esophageal strictures or fistulas caused by tumors.
Look for the model number M00516750 and lot numbers listed in the recall notice, such as 32809369, 32809370, 32820234, etc.
The delivery catheter tip may detach during insertion, potentially causing injury to the esophagus.
Lot numbers 32809369, 32809370, 32820234, 32829719, 32837015, 32859849, 32888837, 32888838, 32914768, 32919658, 32919659, 32938991, 32956256, 32977683, 32980850, 32986659, 32994875, 32998177, 33014830, 33101458, 33119730, 33176329, 33195046, 33195048, 33208043, 33208044, 33218761, 33242625, 33266646, 33266649.
The recall does not require immediate stop use; however, affected units should be checked and handled according to the recall 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-3280-2024 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-3280-2024 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.
