FDA Medical Device Recalls (openFDA)
Northeast Scientific Inc.: 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
- Recall number
- Z-2334-2021
- 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
- Status
- Terminated
- Initiated
- 2021-04-26
- Posted
- not on file
- Terminated
- 2022-03-09
- Reason
- 510k indicated one (1) reprocessing cycle, product not cleared for additional reprocessing cycles.
- 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
- 690 devices
- Distribution
- US Nationwide distribution in the states of CA, CT, FL, GA, IL, MA, NC, NJ, NY, TX.
- Lot, serial or model codes
- Lots L0017886 through L0020553
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- OWQ
- Firm FEI
- 3005467144
- Firm city
- Waterbury
- Firm state
- CT
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28