HIGH

Northeast Scientific NES Reprocessed 2.0mm RX Turbo Elite Laser Atherectomy Catheter Recall 2026

Northeast Scientific recalled 141 units of the NES Reprocessed 2.0mm RX Turbo Elite Laser Atherectomy Catheter nationwide in the United States. The device may have breaches in the sterile barrier packaging that could compromise sterility. Hospitals and patients should stop using the device immediately and await instructions from Northeast Scientific Inc. or their clinicians.

Quick Facts at a Glance

Recall Date
August 29, 2025
Hazard Level
HIGH
Brand
Northeast Scientific
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
1 states
At-Risk Groups
GENERAL

Hazard Information

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

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Northeast Scientific Inc. or your healthcare provider for instructions. Notification method: Letter

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About This Product

The device is a reprocessed laser atherectomy catheter used in vascular procedures to treat infrainguinal stenoses and occlusions. Reprocessed devices are intended for reuse after cleaning and sterilization.

Why This Is Dangerous

A breach in the sterile barrier packaging could allow contaminants to enter the device, risking infection or other sterility-related complications during use.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

Hospitals and clinicians may need to replace the device and monitor patients for potential infections. The recall involves 141 units and may affect patient safety if used.

Practical Guidance

How to identify if yours is affected

  1. Verify model number R-420-159.
  2. Check UDI-DI 00850044399086.
  3. Inspect lot numbers for shelf-life validity (expires before 29AUG2026).

Where to find product info

Recall details and identification numbers are in the FDA recall page and manufacturer letter.

What timeline to expect

Refunds or replacements, if offered, typically follow the manufacturer’s recall process communicated in the recall letter.

If the manufacturer is unresponsive

  • Document all communications with the manufacturer and healthcare facility.
  • Escalate to regulatory authorities if needed.
  • Consult your institution's risk management team.

How to prevent similar issues

  • Always verify UDI and model numbers before use.
  • Ensure devices are sourced through authorized channels.
  • Confirm shelf-life and packaging integrity prior to use.

Documentation advice

Keep the recall notice, packaging, serial numbers, UDI, and all correspondence with the manufacturer and healthcare providers.

Product Details

Model No: R-420-159. UDI-DI: 00850044399086. All lot numbers within shelf life with expiration dates prior to 29AUG2026. Distribution: US nationwide to CA, FL, IL, KS, LA, MD, MI, MO, NC, NJ, NM, NV, NY, PA, TN, TX, VA. Not cleared for marketing in the US. Quantity: 141 units.

Reported Incidents

No injuries or incidents have been reported.

Key Facts

  • 141 units recalled
  • Model R-420-159
  • UDI-DI 00850044399086
  • Shelf-life: expires before 29AUG2026
  • Not cleared for US marketing
  • Sterile barrier breach risk
View Original Recall on FDA - Medical Devices

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Safety Guide

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product TypeLaser Atherectomy Catheter
Sold At
Multiple Retailers

Product Details

Model Numbers
R-420-159
UDI-DI 00850044399086
Affected States
ALL
Report Date
October 8, 2025
Recall Status
ACTIVE

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