Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Malecot Nephrostomy Catheter System Recalled by Boston Scientific Corporation Due to Certain Malecot Nephrostomy Catheters are breaking at the...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Boston Scientific Corporation directly.
Affected Products
Malecot Nephrostomy Catheter System, Product Number: M001224110, GTIN: 08714729030980 The Malecot and the Stenting Malecot Catheters are designed for percutaneous drainage within the renal collecting system while maintaining external access. The Stenting Malecot Nephrostomy Catheter with its extended tip is also designed for internal drainage from the ureteropelvic junction to the bladder.
Quantity: 422
Why Was This Recalled?
Certain Malecot Nephrostomy Catheters are breaking at the mid-shaft bond during use.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Boston Scientific Corporation
Boston Scientific Corporation has 601 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report