Boston Scientific recalls Malecot Nephrostomy Catheters that break at mid-shaft during use. Affected units have specific product numbers and batch dates. Stop using immediately to prevent injury.
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 cause injury if the catheter dislodges or leaks. Affected units have specific product numbers and batch dates.
The catheter can break at the mid-shaft during use, potentially causing leakage or dislodgement. This could lead to infection, bleeding, or other complications if the broken piece remains inside the body.
Patients who have received the recalled catheters for kidney drainage procedures are most at risk. Healthcare providers using these catheters for medical treatments may also be affected.
Check for product number M0064101010 and GTIN 08714729005278. The catheters were sold between January 22, 2018, and October 4, 2021, with specific batch numbers listed in the recall notice.
Discontinue use of the recalled catheter set if you have it.
The product number is M0064101010.
Affected batch numbers include 16682347, 18705536, 20623819, and others listed in the recall notice.
The catheters were sold from January 22, 2018, to October 4, 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-1101-2018 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-1101-2018 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.
