FDA Recalls Reprocessed IVUS Catheters Due to Reprocessing Cycle Violation
Northeast Scientific Inc. is recalling 690 reprocessed intravascular ultrasound catheters because they exceed the FDA-approved single reprocessing cycle limit. Devices were distributed nationwide across ten states.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is a Class II device recall with no reported injuries or illnesses. The hazard is regulatory compliance-based: the product was cleared for one reprocessing cycle only, and the recalled units exceed this limit. Without reported adverse events and with the specific safety risk not detailed in the source, this meets criteria for Moderate severity as a compliance-driven, precautionary recall.
Plain-English summary
The product being recalled is the NES Reprocessed Visions PV .035 IVUS (Intravascular Ultrasound) Catheter, sterile medical devices used to evaluate blood vessel structure in the peripheral vasculature by providing cross-sectional imaging. Approximately 690 units with lot numbers L0017886 through L0020553 are affected by this recall.
Northeast Scientific Inc. initiated the recall because the devices were reprocessed beyond the FDA-approved limit. The FDA 510(k) clearance for this product specified approval for one reprocessing cycle only, and the recalled units exceeded this approved limit.
The affected devices were distributed nationwide to healthcare facilities in California, Connecticut, Florida, Georgia, Illinois, Massachusetts, North Carolina, New Jersey, New York, and Texas. Healthcare providers and patients who possess or have used affected devices should contact Northeast Scientific Inc. or their healthcare provider for guidance on device status and any appropriate follow-up actions.
The recalled product
- 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
- Manufacturer
- Northeast Scientific Inc.
- Hazard
- reprocessing-violation
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lots L0017886 through L0020553
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- HighPhilips Azurion X-Ray Systems Table Movement Control Defect Recall
FDA (Devices) · 2026-05-27
- HighAzurion X-ray System Deaeration Hose May Degrade and Cause Oil Leakage
FDA (Devices) · 2026-05-27
- HighMedtronic DLP Retrograde Cannula Cardiopulmonary Bypass Catheter Recall
FDA (Devices) · 2026-05-27
- HighMedtronic DLP Retrograde Cannula cardiopulmonary bypass catheter
FDA (Devices) · 2026-05-27
- HighTangent Single Use Digital Catheter Recalled for Distal Shaft Fractures
FDA (Devices) · 2026-05-27