Z-2535-2025Class II

Boston Scientific NephroMax Kit, Material Numbers (UPN): 1. M0062101180; 2. M0062101600. (Urology)

Name: Z-2535-2025 Boston Scientific NephroMax Kit, Material Numbers (UPN): 1. M0062101180; 2. M0062101600. (Urology)
Creator: Boston Scientific Corporation
Published: 2025-08-05
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2025-08-05 / Open, Classified

FDA source

Boston Scientific Corporation began a recall of Boston Scientific NephroMax Kit, Material Numbers (UPN): 1. M0062101180; 2. M0062101600. (Urology) on 2025-08-05. FDA classified it as Class II and gives the reason as "The Encore 26 Inflation Device is used with balloon dilation catheters to create and monitor pressure in the balloon and to deflate the balloon. An internal investigation determined that during use, foreign material...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2535-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-08-05
Posted: 2025-09-05
Recalling firm: Boston Scientific Corporation
Product: Boston Scientific NephroMax Kit, Material Numbers (UPN): 1. M0062101180; 2. M0062101600. (Urology)
Product code: LJE Catheter, Nephrostomy
Reason for recall: The Encore 26 Inflation Device is used with balloon dilation catheters to create and monitor pressure in the balloon and to deflate the balloon. An internal investigation determined that during use, foreign material particles could migrate from affected Encore 26 Inflation Devices into a balloon dilatation catheter.
FDA root cause: Under Investigation by firm
Action: Boston Scientific issued an Urgent Medical Device Removal notice to it consignees on 8/5/2025 via letter delivered using a traceable means. The notice explained the issue. potential adverse health consequences associated with use in each device and requested the following instructions be followed: 1. Further distribution or use of any remaining devices affected by this removal should cease immediately. Do NOT use affected devices and remove those devices from your facility s inventory. Segregate the units in a secure place until they can be returned to Boston Scientific. 2. Immediately post this information in a visible location near the affected devices to ensure it is readily accessible to all handlers and users of the device. 3. Forward this notice to any healthcare professional from your organization and to any facilities where affected devices have been transferred, including hospitals or sites within your network. If you are a distributor, this notice must be forwarded to your customers to ensure notification of this device removal is carried out to the end-user level. 4. Complete and return the enclosed Reply Verification Tracking Form per the enclosed instructions on page four of the notice 5. Return affected devices. The entire Encore 26 Advantage Kit, NephroMax Kit, or UroMax Ultra Kit must be returned in order to be reimbursed. For questions, please contact your local sales representative.
Quantity in commerce: 458 units
Distribution: Worldwide distribution.
Product codes and lots: 1. M0062101180, GTIN 08714729077589, Lot Numbers: 35275630, 35603649, 35618255, 35644223, 35768091; 2. M0062101600, GTIN 08714729834540, Lot Numbers: 35268077, 35294478, 35547681, 35576896, 35627459.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2535-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2533-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-09-17	2025-09-05
Z-2534-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-09-17	2025-09-05
Z-2535-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-09-17	2025-09-05
Z-2536-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-09-17	2025-09-05

Product code LJE

K121614UnclassifiedNephromax High Pressure Nephrostomy Baloon Dilatation CatheterBoston Scientific Corp / cleared 2012-09-18

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)