Boston Scientific recalls Malecot Nephrostomy Catheters that may break at mid-shaft during use. Affected units have specific product numbers and batch dates. Stop using if you own these catheters.
Certain Malecot Nephrostomy Catheters are breaking at the mid-shaft bond during use.
Boston Scientific is recalling certain Malecot Nephrostomy Catheters that can break at the mid-shaft during use. This breakage risk could lead to complications if the catheter dislodges or leaks. Affected units have specific product numbers and batch dates.
The catheters can break at the mid-shaft during use, potentially causing leaks or dislodgement. This could lead to complications such as infection or internal bleeding if the broken piece remains in the body or if the catheter becomes obstructed.
Patients who have received the recalled Malecot Nephrostomy Catheters for kidney drainage procedures are most at risk. Healthcare providers who use these catheters for diagnostic or therapeutic kidney treatments may also be affected.
Check for product number M0064201150 and GTIN 08714729009757 on the catheter packaging. Affected units were manufactured between December 10, 2017, and October 29, 2021, with specific batch numbers listed in the recall notice.
Look for product number M0064201150 and GTIN 08714729009757 on the catheter packaging.
If you have the recalled catheter, stop using it immediately to prevent potential breakage and complications.
The product number is M0064201150.
Affected batch numbers include 16602757, 16632804, 16668232, and others listed in the recall notice.
The catheters were manufactured between December 10, 2017, and October 29, 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-1104-2018 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-1104-2018 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.
