Boston Scientific recalls Malecot Nephrostomy Catheter Sets with product number M0064101000 that may break at mid-shaft during use, posing a risk of 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. Owners should check their product numbers and contact Boston Scientific for details.
The catheter can break at the mid-shaft during use, which may cause it to dislodge or leak. This could lead to injury if the broken piece becomes trapped in the body or causes infection.
Patients who have received the recalled catheter set for kidney drainage procedures are most at risk. Healthcare providers using the product for medical treatments may also be affected.
Check for product number M0064101000 and GTIN 08714729005261 on the packaging. The catheters were sold between January 2018 and October 2021.
Look for product number M0064101000 and GTIN 08714729005261 on the catheter packaging.
Reach out to Boston Scientific for instructions on how to return or replace the catheter set.
The catheter may break at the mid-shaft during use, which could cause injury.
Check the product number and contact Boston Scientific for instructions on returning or replacing the catheter.
These catheters were sold between January 2018 and October 2021.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-1100-2018 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-1100-2018 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.
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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.
