NES Laser Atherectomy Catheter Recalled for Sterile Packaging Breach Risk
Northeast Scientific is recalling 165 units of the NES Reprocessed Laser Atherectomy Catheter due to potential breaches in sterile barrier packaging that could compromise sterility assurance.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of a medical device with potential sterile barrier compromise. No illnesses or injuries have been reported, but the hazard represents a risk-of-harm for a medical device used in vascular procedures, warranting a High severity rating per the rubric.
Plain-English summary
Northeast Scientific Inc. is recalling the NES Reprocessed 1.7mm OTW Turbo Elite Laser Atherectomy Catheter (Model R-417-152) due to potential breaches in the sterile barrier packaging. This device is used in vascular treatment procedures to address infrainguinal stenoses and occlusions.
The recall affects 165 units distributed nationwide to medical facilities in California, Florida, Illinois, Kansas, Louisiana, Maryland, Michigan, Missouri, North Carolina, New Jersey, New Mexico, Nevada, New York, Pennsylvania, Tennessee, Texas, and Virginia. All lot numbers within their labeled shelf life with expiration dates prior to August 29, 2026 are included in this recall.
A breach in the sterile barrier packaging could allow contamination, potentially compromising the device's sterility assurance and creating a risk to patient safety during use. Healthcare facilities and individuals who have received this device should contact Northeast Scientific Inc. for instructions on return or replacement. Do not use affected units.
The recalled product
- Product
- NES Reprocessed 1.7mm OTW Turbo Elite Laser Atherectomy Catheter. Model Number: R-417-152. The NES Reprocessed Turbo-Elite Laser Atherectomy Catheter is indicated for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusions. This model is not cl
- Manufacturer
- Northeast Scientific Inc.
- Hazard
- sterile-barrier-breach
- contamination
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 (2)
- Model No R-417-152
- UDI-DI 00850044399093
Distribution
Distributed nationwide across the United States.
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