Device product
NES Reprocessed 1.7mm RX Turbo Elite Laser Atherectomy Catheter. Model Number: R-417-156. 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 cleared for marketing in the US.
Z-0024-2026
Product summary
- Event
- Event 97524
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 616 units
- Official record key
device-enforcement:Z-0024-2026
Official wording
Reason: Potential for breaches in the sterile barrier packaging, compromising sterility assurance.
Code information: Model No R-417-156; UDI-DI 00850044399109; All Lot Numbers that are within their labeled shelf life with expiration dates prior to 29AUG2026.
Distribution pattern: US Nationwide distribution to CA, FL, IL, KS, LA, MD, MI, MO, NC, NJ, NM, NV, NY, PA, TN, TX, VA.
Derived failure modes
-
Unknown
Potential for breaches in the sterile barrier packaging, compromising sterility assurance.