Boston Scientific recalls certain Malecot Nephrostomy Catheter Sets (Product Number M0064101040) that may break at the mid-shaft during use, potentially causing injury. Affected units were sold between March 2018 and September 2021.
Certain Malecot Nephrostomy Catheters are breaking at the mid-shaft bond during use.
Boston Scientific is recalling specific Malecot Nephrostomy Catheter Sets that can break at the mid-shaft during use. This breakage risk could lead to injury if the catheter dislodges or causes internal damage.
The catheter can break at the mid-shaft during use, which may cause it to dislodge or become lodged in the body. This could lead to internal injury or infection if the broken piece remains inside the kidney or urinary tract.
Patients who have been prescribed this catheter set for kidney drainage procedures are most at risk. Healthcare providers using the product for diagnostic or therapeutic kidney treatments may also be affected.
Check for Product Number M0064101040 and GTIN 08714729008446 on the catheter set. Units were sold between March 27, 2018, and September 25, 2021, with specific batch numbers listed in the recall notice.
Look for Product Number M0064101040 and GTIN 08714729008446 on the catheter set.
The catheter may break at the mid-shaft during use, which could cause injury if it dislodges or becomes lodged in the body.
These catheters were sold between March 27, 2018, and September 25, 2021.
Check the product details to see if you have the recalled model. If you do, contact Boston Scientific for further instructions.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-1102-2018 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-1102-2018 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.
