Northeast Scientific NES Turbo Elite Laser Atherectomy Catheter Recall: 199 Units (2025)
Northeast Scientific recalled 199 units of the NES Reprocessed 2.0mm OTW Turbo Elite Laser Atherectomy Catheter. The device is not cleared for marketing in the United States. Distribution covered 17 states nationwide, including CA, FL, IL, KS, LA, MD, MI, MO, NC, NJ, NM, NV, NY, PA, TN, TX, and VA. Healthcare providers were advised to stop use immediately.
About This Product
The device is a reprocessed 2.0mm OTW Turbo Elite Laser Atherectomy Catheter used to treat infrainguinal stenoses and occlusions.
Why This Is Dangerous
A breach in the sterile barrier packaging can compromise sterility, raising infection risk during procedures.
Industry Context
This recall is not described as part of a broader industry pattern.
Real-World Impact
Healthcare facilities must identify affected lots, halt use, and follow manufacturer instructions to safeguard patients.
Practical Guidance
How to identify if yours is affected
- Verify model R-420-006 on the device labeling.
- Check UDI-DI 00850044399079.
- Confirm lot numbers and expiration dates prior to 29AUG2026.
- Ensure devices are not used or distributed further.
Where to find product info
Device labeling and the FDA recall page provide model and UDI details.
What timeline to expect
Immediate recall actions with manufacturer notification by letter; continue to monitor for updates.
If the manufacturer is unresponsive
- Document all contact attempts with the manufacturer.
- Escalate concerns to the FDA recall contact or medical device reporting channels if needed.
How to prevent similar issues
- Verify FDA clearance status before procuring reusable or reprocessed devices.
- Inspect sterile packaging before use and discard any breached packaging.
- Ask suppliers for current recall status and UDI information.
- Maintain an inventory log to isolate recalled lots quickly.
Documentation advice
Keep recall notice, capture device lot and serial numbers, save correspondence with the manufacturer and facilities, document any patient exposure.
Product Details
Model No: R-420-006
UDI-DI: 00850044399079
Not cleared for US marketing
Distribution: US nationwide to CA, FL, IL, KS, LA, MD, MI, MO, NC, NJ, NM, NV, NY, PA, TN, TX, VA
Quantity: 199 units
Sold since: Unknown
Price: Unknown
Reported Incidents
No injuries or incidents have been reported.