The Recall Desk
Agency classClass IIOur severity:SevereFDA (Devices)·Z-1104-2018·Announced 2018-03-28

Boston Scientific Recalls Malecot Nephrostomy Catheters Due to Mid-Shaft Breakage

Boston Scientific is recalling certain Malecot Nephrostomy Catheters 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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when involving structural defects in medical devices that could lead to significant injury.

Plain-English summary

Boston Scientific Corporation is recalling certain Malecot Nephrostomy Catheters, Product Number M0064201150, GTIN 08714729009757. The recall involves 3,762 units of the Percutaneous Access Set. The device is intended to establish percutaneous nephrostomy drainage and is indicated for diagnostic and therapeutic procedures, including antegrade pyelography, pressure/perfusion studies, nephrostomy catheter drainage, and percutaneous nephrolithotomy.

The recall was initiated because certain Malecot Nephrostomy Catheters are breaking at the mid-shaft bond during use. The affected units have expiration dates ranging from 12/10/2017 to 10/29/2021 and include specific batch numbers listed in the agency's structured data. The products were distributed worldwide, including nationwide in the United States and in numerous countries across the Americas, Asia, Africa, and the Middle East.

Healthcare providers and patients should stop using the affected catheters and contact Boston Scientific Corporation for further instructions. The recall is classified as Class II by the FDA, indicating that use of, or exposure to, the violation may cause temporary or medically reversible adverse health consequences or the probability of serious adverse health consequences is remote.

The recalled product

Product
Percutaneous Access Set, Product Number: M0064201150, GTIN: 08714729009757 The Malecot Nephrostomy Catheter Set is intended to establish percutaneous nephrostomy drainage and is indicated for the following: Diagnostic Indications: " Antegrade pyelography " Pressure/perfusion…
Manufacturer
Boston Scientific Corporation
Category
Medical Device — Urological Catheter
Hazard
Affected units
3,762

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: 12/10/2017 - 10/29/2021

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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