NephroMax kits recalled because inflation device particles may enter balloon catheters
Boston Scientific NephroMax Kits are recalled because foreign material particles could migrate from the Encore 26 Inflation Device into a balloon dilatation catheter. 458 units are affected.
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: Rubric level 3 covers risk-of-harm products where injury has not yet been reported; particles migrating into a catheter used inside the body is a potential harm and no injuries are reported.
Plain-English summary
Boston Scientific NephroMax Kits, material numbers M0062101180 and M0062101600, are being recalled. Affected lot numbers include 35275630, 35603649, 35618255, 35644223 and 35768091, with the full list in the recall notice. The recall covers 458 units distributed worldwide.
The Encore 26 Inflation Device, supplied in the kit, is used with balloon dilation catheters to create and monitor pressure in the balloon and to deflate it. An internal investigation determined that during use, foreign material particles could migrate from affected Encore 26 Inflation Devices into a balloon dilatation catheter. The FDA classified the action as Class II.
Hospitals holding these lots should quarantine them and follow the manufacturer's instructions for return or replacement.
The recalled product
- Product
- Boston Scientific NephroMax Kit, Material Numbers (UPN): 1. M0062101180; 2. M0062101600. (Urology)
- Manufacturer
- Boston Scientific Corporation
- Category
- Medical Device — Urology
- Affected units
- 458
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 (14)
- 1. M0062101180
- GTIN 08714729077589
- Lot Numbers: 35275630
- 35603649
- 35618255
- 35644223
- 35768091
- 2. M0062101600
- GTIN 08714729834540
- Lot Numbers: 35268077
- 35294478
- 35547681
- 35576896
- 35627459.
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 4 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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