NES Reprocessed 1.7mm RX Turbo Elite Laser Atherectomy Catheter Recall: 616 Units In US Distribution
Northeast Scientific Inc. has issued a recall for 616 units of the NES Reprocessed Turbo-Elite Laser Atherectomy Catheter, Model R-417-156. The FDA-listed recall cites breaches in sterile barrier packaging that could compromise sterility. The devices were distributed nationwide in the United States to CA, FL, IL, KS, LA, MD, MI, MO, NC, NJ, NM, NV, NY, PA, TN, TX, and VA. Patients should not be in
About This Product
The NES Reprocessed Turbo-Elite Laser Atherectomy Catheter is a medical device used in endovascular treatment, including atherectomy, of infrainguinal stenoses and occlusions. It is not cleared for US marketing.
Why This Is Dangerous
A breach in sterile barrier packaging could compromise sterility assurance and pose infection risk to patients.
Industry Context
This recall is not clearly part of a broader industry pattern in the provided data.
Real-World Impact
Direct impact on patient safety and hospital workflow; immediate device discontinuation required and potential investigation for affected procedures.
Practical Guidance
How to identify if yours is affected
- Verify model number R-417-156 on the device and UDI-DI 00850044399109
- Check shelf-life expiration dates prior to 29AUG2026
- Confirm US distribution status with the hospital’s procurement records
Where to find product info
FDA recall page Z-0024-2026 and manufacturer communications
What timeline to expect
Refunds or replacements are not specified; follow manufacturer guidance and FDA updates
If the manufacturer is unresponsive
- Escalate to hospital compliance department
- Contact FDA recall coordinator if manufacturer is slow to respond
How to prevent similar issues
- Ensure devices are US-cleared before marketing or use
- Verify sterile packaging integrity prior to use
- Implement strict receiving QC to detect packaging breaches
- Maintain documentation of lot numbers and expiration dates
- Consider non-reprocessed device options for high-risk procedures
Documentation advice
Document model, lot, UDI, lot expiration, and communications with manufacturer; retain packaging and labeling for records
Product Details
Model: R-417-156. UDI-DI: 00850044399109. Quantity: 616 units. Distribution: US nationwide to CA, FL, IL, KS, LA, MD, MI, MO, NC, NJ, NM, NV, NY, PA, TN, TX, VA. Sold/used by Northeast Scientific Inc. as reprocessed devices. Not cleared for marketing in the US.
Reported Incidents
No specific patient injuries or incidents are referenced in the provided recall notice.