Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
NES Reprocessed Visions PV .035 IVUS Catheter Recalled by Northeast Scientific Inc. Due to 510k indicated one (1) reprocessing cycle, product not...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Northeast Scientific Inc. directly.
Affected Products
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
Quantity: 690 devices
Why Was This Recalled?
510k indicated one (1) reprocessing cycle, product not cleared for additional reprocessing cycles.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Northeast Scientific Inc.
Northeast Scientific Inc. has 9 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report