Boston Scientific recalls Malecot Nephrostomy Catheters with mid-shaft bond breaking during use. Affected models include Product Number M001224110 and specific 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 Malecot Nephrostomy Catheters that can break at the mid-shaft bond during use. This breakage risk could lead to serious injury if the catheter dislodges inside the body.
The catheters can break at the mid-shaft bond during use, which may cause the catheter to dislodge inside the body. This dislodgement could lead to serious injury or complications requiring immediate medical attention.
Patients who have received the recalled Malecot Nephrostomy Catheters for kidney drainage procedures are affected. Those with the specific product numbers and batch dates listed are at highest risk.
Check for the Product Number M001224110 and GTIN 08714729030980 on the catheter packaging. Affected units were manufactured with specific batch dates between 2/28/2018 and 6/30/2020.
Discontinue use of the recalled Malecot Nephrostomy Catheters to prevent potential breakage and dislodgement.
The catheters can break at the mid-shaft bond during use, which may cause dislodgement inside the body and lead to serious injury.
Product Number M001224110 and GTIN 08714729030980.
The affected catheters were manufactured with batch dates between 2/28/2018 and 6/30/2020.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-1099-2018 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-1099-2018 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.
