Boston Scientific Recalls Malecot Nephrostomy Catheters Due to Mid-Shaft Breakage
Boston Scientific is recalling Malecot Nephrostomy Catheter Sets because they are breaking 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 with a structural defect (breaking during use) that poses a risk of harm, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Boston Scientific Corporation is recalling Malecot Nephrostomy Catheter Sets, Product Number M0064101010, GTIN 08714729005278. The recall involves 1,716 units distributed nationwide in the United States and in various countries worldwide.
The recall was initiated because certain catheters are breaking at the mid-shaft bond during use. The affected products are indicated for diagnostic and therapeutic procedures, including antegrade pyelography, pressure/perfusion studies, nephrostomy catheter drainage, and percutaneous nephrolithotomy.
Healthcare providers and patients should stop using the affected catheters. The source text does not specify specific instructions for disposal or replacement, but users should contact Boston Scientific or their medical provider for guidance.
The recalled product
- Product
- Malecot Nephrostomy Catheter Set, Product Number: M0064101010, GTIN: 08714729005278 The Malecot Nephrostomy Catheter Set is intended to establish percutaneous nephrostomy drainage and is indicated for the following: Diagnostic Indications: " Antegrade pyelography "…
- Manufacturer
- Boston Scientific Corporation
- Affected units
- 1,716
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: 1/22/2018 - 10/4/2021
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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