Boston Scientific recalls specific Malecot Nephrostomy Catheter Sets (Product Number M0064101050) that may break at the mid-shaft during use, potentially causing injury. Affected units were sold between January 2018 and October 2021.
Certain Malecot Nephrostomy Catheters are breaking at the mid-shaft bond during use.
Boston Scientific is recalling certain Malecot Nephrostomy Catheter Sets that can break at the mid-shaft during use. This breakage could lead to injury if the catheter dislodges or leaks. Patients using these catheters should stop using them immediately.
The catheter can break at the mid-shaft during use, which may cause it to dislodge or leak. This could lead to internal injury or infection if the broken piece remains inside the body.
Patients with a specific Malecot Nephrostomy Catheter Set (Product Number M0064101050) purchased between January 2018 and October 2021 are affected. Those with the catheter in place are at the highest risk of injury.
Check for Product Number M0064101050 on the catheter set. The catheter was sold between January 14, 2018 and October 9, 2021. The GTIN is 08714729192268.
Immediately stop using the catheter set if you have it. Do not attempt to repair it yourself.
Product Number M0064101050
Between January 14, 2018 and October 9, 2021.
Check for Product Number M0064101050 and GTIN 08714729192268 on the catheter set.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-1103-2018 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-1103-2018 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.
