FDA Device recall Z-1672-2013
NephroMax high Pressure Nephrostomy Balloon Catheter
- FDA Device
- Class II
- terminated
- Published 2013-07-17
On 2013-07-17 the FDA classified a Class II recall of NephroMax high Pressure Nephrostomy Balloon Catheter by Boston Scientific, citing incorrect sized renal sheath was packaged with the NephroMax high pressure nephrostomy Balloon Catheter.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1672-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-05-28 |
| Published | 2013-07-17 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Boston Scientific |
| Distribution | US |
Product
NephroMax high Pressure Nephrostomy Balloon Catheter. Material Number/Catalog Number: M0062101400/210-140, M062101440/210144 Dilation of the nephrostomy tract.
Reason
Incorrect sized renal sheath was packaged with the NephroMax high pressure nephrostomy Balloon Catheter.
Identifiers
| code_info | Lot Number: 15875861, 15875860, 15875299, 15872797, 15872799, 15872798 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1672-2013%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.