The Recall Desk
HighFDA (Devices)·Z-1102-2018·Announced 2018-03-28

Boston Scientific Recalls Malecot Nephrostomy Catheters Due to Breakage

Boston Scientific is recalling Re-Entry Malecot Nephrostomy Catheter Sets because they may break at the mid-shaft bond during use.

What this means for you

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 is classified as FDA Class II. The hazard involves a structural failure (breakage) of a medical device during use, which poses a risk of harm, but the source text does not report any specific injuries or illnesses.

Plain-English summary

Boston Scientific Corporation is recalling the Re-Entry Malecot Nephrostomy Catheter Set, Product Number M0064101040. The recall involves 2,224 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 device is intended to establish percutaneous nephrostomy drainage and is indicated for diagnostic and therapeutic procedures, including antegrade pyelography, pressure/perfusion studies, and nephrostomy catheter drainage.

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 the manufacturer or their supplier for guidance.

The recalled product

Product
Re-Entry" Malecot Nephrostomy Catheter Set, Product Number: M0064101040, GTIN: 08714729008446 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
Category
Medical Device — Urological Catheters
Hazard
Affected units
2,224

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: 3/27/2018 9/25/2021

Distribution

Distributed nationwide across the United States.

The notice also names 43 states specifically:

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.

See all 6 products in this recall →

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