Boston Scientific Recalls Malecot Nephrostomy Catheters Due to Breakage
Boston Scientific is recalling 422 units of Malecot Nephrostomy Catheters because they may break at the mid-shaft bond during use.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device defect (breakage during use) that poses a risk of harm, but the source text does not report any specific injuries, illnesses, or fatalities, fitting the criteria for a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Boston Scientific Corporation is recalling 422 units of the Malecot Nephrostomy Catheter System (Product Number: M001224110, GTIN: 08714729030980). The recall was initiated because certain catheters are breaking at the mid-shaft bond during use.
The affected products are designed for percutaneous drainage within the renal collecting system while maintaining external access. The Stenting Malecot Nephrostomy Catheter variant is also designed for internal drainage from the ureteropelvic junction to the bladder. The recall covers units with expiration dates ranging from February 28, 2018, to June 30, 2020, and specific batch numbers listed in the agency's records.
The products were distributed worldwide, including nationwide in the United States and in numerous countries across the Americas, Europe, Asia, Africa, and the Middle East. Healthcare providers and patients should stop using the affected catheters and contact Boston Scientific for instructions on replacement or return.
The recalled product
- Product
- 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…
- Manufacturer
- Boston Scientific Corporation
- Category
- Medical Device — Catheters
- Hazard
- Affected units
- 422
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Expiration Date Range: 2/28/2018 - 6/30/2020
Distribution
Part of a larger recall action
This product is one of 6 recalled by Boston Scientific Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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