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.
Reported: October 8, 2025 Initiated: August 29, 2025 #Z-0024-2026
Product Description
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.
Reason for Recall
Potential for breaches in the sterile barrier packaging, compromising sterility assurance.
Details
- Recalling Firm
- Northeast Scientific Inc.
- Units Affected
- 616 units
- Distribution
- US Nationwide distribution to CA, FL, IL, KS, LA, MD, MI, MO, NC, NJ, NM, NV, NY, PA, TN, TX, VA.
- Location
- Waterbury, CT
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Northeast Scientific Inc.. Units affected: 616 units.
Why was this product recalled? ▼
Potential for breaches in the sterile barrier packaging, compromising sterility assurance.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 8, 2025. Severity: Moderate. Recall number: Z-0024-2026.
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