Boston Scientific recalls specific batches of iSLEEVE 14F Expandable Introducer Sets due to reported hemostatic valve leaks that could cause bleeding during vascular procedures.
Boston Scientific is conducting a removal of specific batches of the iSLEEVETM 14F Expandable Introducer Set due to complaints associated with a hemostatic valve leak.
Boston Scientific is recalling certain batches of their iSLEEVE 14F Expandable Introducer Sets because of reported hemostatic valve leaks. This could lead to uncontrolled bleeding during vascular procedures, which is a serious risk for patients undergoing surgery.
The hemostatic valve in the iSLEEVE 14F Expandable Introducer Set may leak, causing uncontrolled bleeding during vascular procedures. This leak could occur when the device is used to access the vascular system, potentially leading to significant blood loss in patients.
Healthcare professionals using the iSLEEVE 14F Expandable Introducer Set for femoral vascular access procedures are most at risk. Patients undergoing such procedures with the recalled batches could experience uncontrolled bleeding.
Check for the product name 'iSLEEVE EXPANDABLE Introducer Set' with the specific batch numbers listed in the recall notice. The product is sold with the GTIN 08714729950660 and the batch numbers provided in the recall.
Look for the batch numbers listed in the recall: 31368041, 31390084, 31390088, and other specific batch numbers provided in the notice.
Reach out to Boston Scientific Corporation directly for further assistance or to confirm if your device is affected.
Boston Scientific is recalling specific batches of the iSLEEVE 14F Expandable Introducer Set due to complaints about hemostatic valve leaks that could cause uncontrolled bleeding during vascular procedures.
Check the batch numbers listed in the recall: 31368041, 31390084, 31390088, and other specific batch numbers provided in the notice. The product is sold with the GTIN 08714729950660.
Contact Boston Scientific Corporation directly to confirm if your device is affected and to get 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-1390-2024 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-1390-2024 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.
