NephroMax high Pressure Nephrostomy Balloon Catheter — Class II medical device recall Z-1672-2013
Terminated recall by Boston Scientific Corporation, reported 2013-07-17, distributed nationwide. Incorrect sized renal sheath was packaged with the NephroMax high pressure nephrostomy Balloon Catheter.
| Recall number | Z-1672-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Boston Scientific Corporation, Marlborough, MA, United States |
| Recall initiated | 2013-05-28 |
| Classified | 2013-07-09 |
| Reported by FDA | 2013-07-17 |
| Terminated | 2014-01-23 |
| Distributed | Nationwide (US) |
| Countries outside the US | DK, ES, GB |
| Quantity | 27 |
| Lot numbers | 15872797, 15872798, 15872799, 15875299, 15875860, 15875861 |
| Model numbers | M0062101400/210-140, M062101440/210144 |
Product
NephroMax high Pressure Nephrostomy Balloon Catheter. Material Number/Catalog Number: M0062101400/210-140, M062101440/210144 Dilation of the nephrostomy tract.
Reason for recall
Incorrect sized renal sheath was packaged with the NephroMax high pressure nephrostomy Balloon Catheter.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1672-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.