FDA Device recall Z-2334-2021
NES Reprocessed Visions PV .035 IVUS Catheter, Sterile
- FDA Device
- Class II
- terminated
- Published 2021-09-01
On 2021-09-01 the FDA classified a Class II recall of NES Reprocessed Visions PV .035 IVUS Catheter, Sterile by Northeast Scientific, citing 510k indicated one (1) reprocessing cycle, product not cleared for additional reprocessing cycles.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2334-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-04-26 |
| Published | 2021-09-01 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Northeast Scientific |
| Distribution | US |
Product
NES Reprocessed Visions PV .035 IVUS Catheter, Sterile. For use in the evaluation of vascular morphology in blood vessels of the peripheral vasculature by providing a crosssectional image of such vessels. NES Ref. No. R-88901
Reason
510k indicated one (1) reprocessing cycle, product not cleared for additional reprocessing cycles.
Identifiers
| code_info | Lots L0017886 through L0020553 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2334-2021%22
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