Z-2334-2021Class II

NES Reprocessed Visions PV .035 IVUS Catheter, Sterile. For use in the evaluation of vascular morphology in...

Name: Z-2334-2021 NES Reprocessed Visions PV .035 IVUS Catheter, Sterile. For use in the evaluation of vascular morphology in...
Creator: Northeast Scientific Inc.
Published: 2021-04-26
License: https://open.fda.gov/license/

Northeast Scientific Inc. / initiated 2021-04-26 / Terminated

FDA source

Northeast Scientific Inc. began a recall of NES Reprocessed Visions PV .035 IVUS Catheter, Sterile. For use in the evaluation of vascular morphology in blood vessels of the peripheral vasculature by... on 2021-04-26. FDA classified it as Class II and gives the reason as "510k indicated one (1) reprocessing cycle, product not cleared for additional reprocessing cycles". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2334-2021
Classification: Class II
Status: Terminated
Initiated: 2021-04-26
Posted: 2021-08-23
Terminated: 2022-03-09
Recalling firm: Northeast Scientific Inc.
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
Product code: OWQ Reprocessed Intravascular Ultrasound Catheter
Reason for recall: 510k indicated one (1) reprocessing cycle, product not cleared for additional reprocessing cycles.
FDA root cause: No Marketing Application
Action: Northeast Science contacted customers by telephone and email on 4/26/21. Customers were asked if inventory remained of the affected lot numbers. Had any of the customers had inventory they would have been instructed to return the products. No inventory was found of the affected lots.
Quantity in commerce: 690 devices
Distribution: US Nationwide distribution in the states of CA, CT, FL, GA, IL, MA, NC, NJ, NY, TX.
Product codes and lots: Lots L0017886 through L0020553

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2334-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2334-2021	Class II	Terminated	Voluntary: Firm initiated	2021-09-01	2021-08-23

Product code OWQ

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)