Boston Scientific recalls 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 listed in the recall notice.
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 certain Emerge Monorail PTCA Dilatation Catheters that may have missed a critical hydrophilic coating step during manufacturing. This could create a slippery surface that might cause complications during medical procedures. Affected units include specific sizes and lot numbers listed in the recall notice.
The catheters may have missed the hydrophilic coating step during manufacturing, which normally creates a slippery surface to reduce friction during procedures. Without this coating, the catheter could become too slippery, potentially causing complications like dislodging blood vessels or causing tissue damage during insertion.
Medical professionals who use these catheters for procedures like angioplasty are most at risk. Patients who have received these catheters during procedures are not affected by the recall.
Check the product label for the model name 'Emerge Monorail PTCA Dilatation Catheter' and the specific size (e.g., 2.00mm X 8mm). The recall includes 20 different sizes and specific lot numbers listed in the notice.
Look for the model name and size on the catheter packaging or label to determine if it is affected.
The catheters may have missed the hydrophilic coating step during manufacturing, creating a slippery surface that could cause complications during medical procedures.
The recall includes 20 specific sizes (e.g., 2.00mm X 8mm) and specific lot numbers listed in the notice.
Patients who received these catheters during procedures are not affected by the recall and do not need to take action.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-0577-2020 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-0577-2020 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.
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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.
