NES Reprocessed 0.9mm RX Turbo Elite Laser Atherectomy Catheter R-410-154Recalls & reported problems

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier, 1 still open.

1 other recall cover devices cleared under the same FDA submission (K220171); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Aug 29, 2025Class IIOpen, Classified

   Potential for breaches in the sterile barrier packaging, compromising sterility assurance.

   Z-0022-2026 · Root cause: Process control · Recall details · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K220171. One submission often covers many models, so check the product and lot details in each record.

• Z-0018-2026 · Aug 29, 2025 · Open, Classified
  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 t