HIGH

Northeast Scientific NES Reprocessed 1.4mm OTW Turbo Elite Laser Atherectomy Catheter Recall 173 Un­

Northeast Scientific recalled 173 units of the NES Reprocessed 1.4mm OTW Turbo Elite Laser Atherectomy Catheter distributed nationwide to U.S. healthcare facilities. The device is not cleared for marketing in the United States due to sterility concerns. A breach in the sterile barrier packaging could compromise sterility. Health care providers and patients should stop using the device immediately.

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 NES Reprocessed Turbo Elite Laser Atherectomy Catheter is a vascular device used to treat infrainguinal stenoses and occlusions. It is reprocessed and marketed in some regions but not cleared for US marketing.

Why This Is Dangerous

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

Industry Context

This recall is not described as part of a broader industry pattern in the notice.

Real-World Impact

Hospitals and clinics may need to quarantine affected units and review sterile-packaging controls. The recall creates potential treatment delays for patients relying on this catheter.

Practical Guidance

How to identify if yours is affected

  1. Verify model number R-414-151 and UDI 00850044399116 on the device label or packaging.
  2. Check lot numbers against shelf-life criteria (within shelf life and expiration before 29AUG2026).
  3. Confirm that the device was distributed in the US and returned per recall instructions.

Where to find product info

Refer to the FDA recall page for Z-0019-2026 and the NES recall notification for instructions and remedies.

What timeline to expect

Not specified by the manufacturer.

If the manufacturer is unresponsive

  • Escalate with hospital procurement and risk management.
  • File a complaint with the FDA if the manufacturer does not respond in a timely manner.

How to prevent similar issues

  • Verify sterile barrier integrity before use in any device reuse program.
  • Ensure strict adherence to packaging standards for reprocessed devices.
  • Coordinate with suppliers to ensure recalled lots are removed from inventory.

Documentation advice

Keep recall notices, purchase records, packaging images, and all correspondence with the manufacturer for audit and potential claims.

Product Details

Model No: R-414-151 UDI-DI: 00850044399116 Sold: US nationwide distribution to CA, FL, IL, KS, LA, MD, MI, MO, NC, NJ, NM, NV, NY, PA, TN, TX, VA Sold since: Not cleared for US marketing Quantity: 173 units Shelf-life: Expiration dates prior to 29AUG2026 Price: Unknown

Reported Incidents

No injuries or incidents have been reported.

Key Facts

  • 173 units recalled
  • Not cleared for US marketing
  • Model R-414-151
  • UDI-DI 00850044399116
  • Shelf life through 29AUG2026
  • US nationwide distribution to listed states
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-414-151
UDI-DI 00850044399116
Affected States
ALL
Report Date
October 8, 2025
Recall Status
ACTIVE

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