NES Turbo Elite Laser Atherectomy Catheter Recalled for Sterile Barrier Defect
Northeast Scientific is recalling the NES Reprocessed Turbo Elite Laser Atherectomy Catheter due to potential breaches in sterile barrier packaging that may compromise device sterility. The recall affects 173 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: This is a risk-of-harm medical device where sterile barrier compromise poses an infection risk during invasive vascular procedures. Although no patient injuries have been reported to date, the potential hazard is significant given the critical application. FDA Class II classification without reported hospitalizations supports this score.
Plain-English summary
Northeast Scientific Inc. is recalling the NES Reprocessed 1.4mm OTW Turbo Elite Laser Atherectomy Catheter (Model R-414-151) due to potential breaches in the sterile barrier packaging. The catheter is intended for use in treating arterial stenoses and occlusions through laser atherectomy in peripheral vascular interventions.
The recall affects 173 units that were distributed nationwide to healthcare facilities in California, Florida, Illinois, Kansas, Louisiana, Maryland, Michigan, Missouri, North Carolina, New Jersey, New Mexico, Nevada, New York, Pennsylvania, Tennessee, Texas, and Virginia. The affected devices carry model number R-414-151, UDI-DI 00850044399116, and include all lot numbers within their labeled shelf life with expiration dates prior to August 29, 2026.
Breaches in sterile barrier packaging compromise the sterility assurance of surgical devices. While no patient illnesses or injuries related to this defect have been reported, the use of potentially contaminated surgical catheters during vascular interventions carries a risk of infection.
Patients and healthcare providers in possession of the recalled device should contact Northeast Scientific Inc. immediately. Healthcare facilities should verify device lot numbers and expiration dates against the recall information and follow the manufacturer's instructions regarding device handling and disposition.
The recalled product
- Product
- NES Reprocessed 1.4mm OTW Turbo Elite Laser Atherectomy Catheter. Model Number: R-414-151. 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 no
- Manufacturer
- Northeast Scientific Inc.
- Hazard
- sterile-barrier-breach
- microbial-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-414-151
- UDI-DI 00850044399116
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- SevereMedline spinal anesthesia kits recalled for bupivacaine quality issues
FDA (Devices) · 2026-06-03
- HighGE CARESCAPE Telemetry Server may lose patient ECG and oxygen saturation monitoring
FDA (Devices) · 2026-06-03
- HighGE APEXPRO and CARESCAPE Telemetry Systems Risk Loss of Patient Monitoring
FDA (Devices) · 2026-06-03
- SevereMedline Spinal Trays Recalled Due to Quality and Efficacy Concerns
FDA (Devices) · 2026-06-03
- HighPhilips Azurion and Allura Imaging Systems Recalled for Hard Drive Degradation
FDA (Devices) · 2026-06-03