Laser Atherectomy Catheter Recall Due to Sterile Packaging Defects
Northeast Scientific is recalling the NES Reprocessed Turbo Elite Laser Atherectomy Catheter due to potential breaches in sterile barrier packaging. The defect could compromise sterility assurance on 141 units distributed nationwide.
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: FDA Class II medical device recall with potential for patient harm via sterile barrier compromise on an invasive surgical device. No hospitalizations, injuries, or deaths have been reported. Per the rubric, this is a risk-of-harm product where injury has not yet been reported, warranting a High (3) severity score.
Plain-English summary
Northeast Scientific Inc. is recalling the NES Reprocessed 2.0mm RX Turbo Elite Laser Atherectomy Catheter (Model R-420-159). This surgical device is used in the treatment of infrainguinal stenoses and occlusions via laser atherectomy, a minimally invasive procedure.
The recall was issued due to potential breaches in the sterile barrier packaging. These breaches could compromise the sterility assurance of the device.
A total of 141 units have been distributed nationwide to 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 affected units have model number R-420-159 with expiration dates prior to August 29, 2026.
The recalled product
- Product
- NES Reprocessed 2.0mm RX Turbo Elite Laser Atherectomy Catheter. Model Number: R-420-159. 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
- sterility-compromise
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-420-159
- UDI-DI 00850044399086
Distribution
Distributed nationwide across the United States.
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