Boston Scientific recalls Guidezilla II Guide Extension Catheters that may have missed hydrophilic coating during manufacturing, creating a lubricious surface. Affected units include specific sizes and lot numbers from 2019-2021.
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 Guidezilla II Guide Extension Catheters that may have missed a critical hydrophilic coating step during production. This could create a slippery surface that might cause injury during medical procedures. Affected units have specific size and lot numbers listed in the recall notice.
The catheters may have missed the hydrophilic coating step during manufacturing, creating a lubricious surface. This could lead to unintended movement or injury during medical procedures if the slippery surface causes the catheter to slip or move unexpectedly.
Medical professionals using these catheters for procedures are most at risk. Patients receiving these catheters during procedures could be affected if the coating issue occurs.
Check for the specific sizes: 6F or 7F. Look for lot numbers like 23485544, 23933296, 23947883, or 24137846 with the GTIN 8714729939450 or 8714729939474. These units were sold between September 2019 and June 2021.
Review the lot number and size on the catheter packaging to confirm if it matches the affected units listed in the recall.
The catheters may have missed the hydrophilic coating step during manufacturing, creating a lubricious surface that could cause injury during medical procedures.
Check the product details against the affected lot numbers and sizes listed in the recall notice to see if your unit is affected.
The recall indicates a potential risk of unintended movement or injury due to the slippery surface, but no specific injuries have been reported.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-0578-2020 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-0578-2020 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.
