Boston Scientific recalls NC Emerge Monorail PTCA Dilatation Catheters that may have missed hydrophilic coating during manufacturing, creating a slippery surface. Affected units include specific sizes and lot numbers.
Certain dilation and extension catheters are being recalled because these catheters may have missed the hydrophilic coating step, which creates a lubricious surface on the devices, during the manufacturing process.
Boston Scientific is recalling NC Emerge Monorail PTCA Dilatation Catheters that may have missed the hydrophilic coating step during manufacturing. This creates a slippery surface that could cause injury during medical procedures.
The catheters may have missed the hydrophilic coating step during manufacturing, creating a slippery surface. This could lead to injury during medical procedures if the catheter slips or moves unexpectedly.
Medical professionals who use these catheters for procedures like angioplasty. Patients undergoing such procedures with affected catheters are at risk of injury.
Check for the product names: NC Emerge Monorail PTCA Dilatation Catheter. Look for specific sizes and lot numbers listed in the recall notice. The affected units include 15 different sizes with specific catalog numbers and dates.
Review the product's catalog number and lot number to determine if it's affected. The recall includes specific sizes and lot numbers listed in the notice.
The catheters may have missed the hydrophilic coating step during manufacturing, creating a slippery surface that could cause injury during medical procedures.
The recall includes 15 different sizes with specific catalog numbers and lot numbers listed in the notice. Affected units have catalog numbers like H7493926708350 through H7493927615350 and specific lot numbers.
The recall does not specify a stop-use instruction. Medical professionals should check product details to determine if their catheters are affected.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-0579-2020 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-0579-2020 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.
