The Recall Desk
HighFDA (Devices)·Z-0021-2026·Announced 2025-10-08

FDA Recalls Laser Atherectomy Catheter Due to Sterile Barrier Breach Risk

Northeast Scientific is recalling the NES Reprocessed Turbo Elite Laser Atherectomy Catheter due to potential breaches in the sterile barrier packaging. The compromised sterility could increase infection risk during vascular procedures.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall for a potential sterile barrier breach on a surgical catheter used in vascular procedures. The hazard is theoretical with no reported illnesses or injuries, fitting the criterion of 'risk-of-harm products where injury has not yet been reported,' which corresponds to Score 3.

Plain-English summary

Northeast Scientific Inc. is recalling the NES Reprocessed 2.0mm OTW Turbo Elite Laser Atherectomy Catheter (Model R-420-006) due to potential breaches in the sterile barrier packaging. This device is used for laser-assisted treatment of narrowed or blocked blood vessels in the legs.

The sterile barrier packaging is designed to maintain the device in a sterile state until use. A breach in this barrier could compromise the sterility of the catheter, potentially increasing the risk of contamination or infection when the device is used in vascular intervention procedures.

The recall affects 199 units distributed nationwide to healthcare facilities in 17 states: California, Florida, Illinois, Kansas, Louisiana, Maryland, Michigan, Missouri, North Carolina, New Jersey, New Mexico, Nevada, New York, Pennsylvania, Tennessee, Texas, and Virginia. Affected lots include all units with expiration dates prior to August 29, 2026 (Model R-420-006; UDI-DI 00850044399079).

Healthcare providers should discontinue use of affected units. Patients who may have received this device during a vascular procedure should consult with their healthcare provider about any concerns.

The recalled product

Product
NES Reprocessed 2.0mm OTW Turbo Elite Laser Atherectomy Catheter. Model Number: R-420-006. 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 cl
Manufacturer
Northeast Scientific Inc.
Category
Medical Device — Vascular Intervention
Hazard
  • sterile-barrier-breach
  • infection-risk

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Model No R-420-006
  • UDI-DI 00850044399079

Distribution

Distributed nationwide across the United States.

Related recalls

Same category