NES Reprocessed Laser Atherectomy Catheter Recalled for Sterile Packaging Breach
Northeast Scientific Inc. is recalling 1,019 units of its NES Reprocessed 1.4mm Turbo Elite Laser Atherectomy Catheter (Model R-414-159) due to potential sterile barrier breaches that could compromise device sterility.
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 FDA Class II medical device recall involves potential sterile barrier breaches that create a risk of infection if devices are used. No illnesses, injuries, or hospitalizations have been reported. The hazard is potential rather than confirmed.
Plain-English summary
Northeast Scientific Inc. is recalling 1,019 units of the NES Reprocessed 1.4mm RX Turbo Elite Laser Atherectomy Catheter (Model R-414-159). This device is indicated for treating infrainguinal arterial stenoses and occlusions but is not cleared for marketing in the United States.
The recall is due to potential breaches in the sterile barrier packaging that could compromise sterility assurance. Compromised sterility poses a risk of device contamination and infection if affected units are used.
The recalled devices were distributed nationwide to healthcare facilities in 17 states: 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 with labeled shelf life and expiration dates prior to August 29, 2026 are affected.
Healthcare facilities with this device should contact Northeast Scientific Inc. immediately for return and replacement instructions. Do not use any affected units.
The recalled product
- Product
- NES Reprocessed 1.4mm RX Turbo Elite Laser Atherectomy Catheter. Model Number: R-414-159. 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 cle
- Manufacturer
- Northeast Scientific Inc.
- Hazard
- sterile-barrier-breach
- infection-risk
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-414-159
- UDI-DI 00850044399123
Distribution
Distributed nationwide across the United States.
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