Boston Scientific NephroMax Kit Recall: Foreign Particles Risk
Boston Scientific recalls NephroMax Kit (UPNs M0062101180, M0062101600) due to foreign material particles migrating into balloon catheters during use. Affected units include specific lot numbers and GTINs.
Use caution until it’s fixed
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.
Contact the company
What happened, in plain English
Boston Scientific is recalling NephroMax Kits with specific material numbers and lot numbers because foreign particles can migrate into balloon catheters during use. This could lead to complications in urological procedures. Read more at govinfonow.com/recall/51677-boston-scientific-nephromax-kit-recall-foreign-particles-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/51677-boston-scientific-nephromax-kit-recall-foreign-particles-risk · Updated August 17, 2026 · FDA enforcement record: FDA #Z-2535-2025
Cite this page
“Boston Scientific NephroMax Kit Recall: Foreign Particles Risk.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/51677-boston-scientific-nephromax-kit-recall-foreign-particles-risk. Based on FDA recall #Z-2535-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2535-2025%22&limit=1).
Why it’s dangerous
Foreign material particles can migrate from the Encore 26 Inflation Device into the balloon dilatation catheter during use. This migration could cause complications during urological procedures where pressure is monitored and adjusted.
Who’s affected
Urology patients and healthcare providers using the recalled NephroMax Kits for balloon dilation procedures. Those with the specific material numbers and lot numbers are most at risk.
How to tell if you have this one
Check for material numbers M0062101180 or M0062101600. The kits include specific lot numbers and GTINs listed in the recall notice.
- Brand
Boston Scientific- Product
Boston Scientific NephroMax Kit, Material Numbers (UPN): 1. M0062101180; 2. M0062101600. (Urology)- Category
Medical device
All 4 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Ongoing- Distribution
Worldwide distribution.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-2533-2025 | Boston Scientific Encore 26 Inflation Device, Material Numbers (UPN): 1. H74904526011; 2. H74904526052; 3. M0067101140; 4. M001151050; 5. M001151062; 6. M00566670. (Interventional Cardiology, Peripheral Interventions); 1. H74904526011, GTIN 8714729177029, Lot Numbers: 34915076, 35065978; 2. H74904526052, GTIN 8714729127062, Lot Numbers: 34915078, 34915220; 3. M0067101140, GTIN 8714729755814, Lot Numbers: 34892421; 4. M001151050, GTIN 8714729183624, Lot Numbers: 34966934; 5. M001151062, GTIN 8714729137542, Lot Numbers: 34873498; 6. M00566670, GTIN 8714729755241, Lot Numbers: 35045668. | 39739 units |
| Z-2534-2025 | Boston Scientific Encore Advantage Kit, Material Numbers (UPN): 1. H74904527011; 2. H74904527052. (Interventional Cardiology and Peripheral Interventions); 1. H74904527011, GTIN 08714729180005, Lot Numbers: 34783060, 34849364, 34873499, 34942522, 34976509, 35017763, 35065979, 35067000; 2. H74904527052, GTIN 08714729127048, Lot Numbers: 34873681, 34915075, 34942524, 34986473, 34986475. | 68347 units |
| Z-2535-2025 | Boston Scientific NephroMax Kit, Material Numbers (UPN): 1. M0062101180; 2. M0062101600. (Urology); 1. M0062101180, GTIN 08714729077589, Lot Numbers: 35275630, 35603649, 35618255, 35644223, 35768091; 2. M0062101600, GTIN 08714729834540, Lot Numbers: 35268077, 35294478, 35547681, 35576896, 35627459. | 458 units |
| Z-2536-2025 | Boston Scientific UroMax Ultra Kit, Material Numbers (UPN): 1. M0062251200, 2. M0062251210, 3. M0062251220, 4. M0062251230, 5. M0062251240, 6. M0062251260, 7. M0062251290, 8. M0062251300, 9. M0062251310. 10. M0062251350, 11. M0062251360, 12. M0062251370. (Urology); 1. M0062251200, GTIN 8714729341277, Lot Numbers: 35536688, 35538633, 35538634, 35543803, 35543804, 35572728, 35678100; 2. M0062251210, GTIN 8714729341284, Lot Numbers: 35274797, 35274799, 35277223, 35277224, 35294475, 35294476, 35584203, 35584215, 35656798, 35667482, 35667483; 3. M0062251220, GTIN 8714729341291, Lot Numbers: 35257438, 35535450, 35536202, 35547680, 35656799; 4. M0062251230, GTIN 8714729341307, Lot Numbers: 35266389, 35543805; 5. M0062251240, GTIN 8714729341314, Lot Numbers: 35690647; 6. M0062251260, GTIN 8714729341338, Lot Numbers: 35537838, 35537839. 7. M0062251290, GTIN 08714729341369, Lot Numbers: 35266391; 8. M0062251300, GTIN 08714729341376, Lot Numbers: 35275806, 35536992; 9. M0062251310, GTIN 08714729341383, Lot Numbers: 35536991; 10. M0062251350, GTIN 08714729341390, Lot Numbers: 35690648; 11. M0062251360, GTIN 08714729302421, Lot Numbers: 35257611, 35536990; 12. M0062251370, GTIN 08714729302438, Lot Numbers: 35294477, 35536689. | 1369 units |
What to do — step by step
Check Product Details
Identify the material numbers (M0062101180 or M0062101600) and lot numbers listed in the recall notice.
How this recall unfolded
Recall timeline
FDA published this recall 43 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
Questions people ask
Which lot numbers are affected?
Lot numbers 35275630, 35603649, 35618255, 35644223, 35768091 for material number M0062101180 and 35268077, 35294478, 35547681, 35576896, 35627459 for material number M0062101600.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-2535-2025 (August 5, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2535-2025 to see it in context.
- Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.