Device product
NES Reprocessed 0.9mm OTW Turbo Elite Laser Atherectomy Catheter. Model Number: R-410-152. The NES Reprocessed Turbo-Elite Laser Atherectomy Catheter is indicated for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusions.
Z-0018-2026
Product summary
- Event
- Event 97524
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 561 units
- Official record key
device-enforcement:Z-0018-2026
Official wording
Reason: Potential for breaches in the sterile barrier packaging, compromising sterility assurance.
Code information: Model No R-410-152; UDI-DI 00850044399055; 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.