HIGH

Northeast Scientific NES Reprocessed 0.9mm Turbo Elite Laser Atherectomy Catheter Recall 2025

Northeast Scientific recalled 795 NES Reprocessed 0.9mm RX Turbo Elite Laser Atherectomy Catheters nationwide. The device is not cleared for marketing in the United States. The recall cites breaches in sterile barrier packaging that could compromise sterility. Hospitals and providers should stop using the device immediately and follow manufacturer instructions.

Quick Facts at a Glance

Recall Date
August 29, 2025
Hazard Level
HIGH
Brand
Northeast Scientific
Category
Health & Personal Care
Sold At
Unknown
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

This device is a reprocessed laser atherectomy catheter used to treat infrainguinal stenoses and occlusions. Reprocessing entails cleaning and sterilizing used devices for reuse in clinical settings.

Why This Is Dangerous

A breach in sterile barrier packaging can allow contamination, potentially leading to infection during catheter use.

Industry Context

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

Real-World Impact

Hospitals may need to halt procedures involving this catheter and coordinate replacements or alternative therapies. Reprocessing-related recalls can drive additional cost and workflow disruption.

Practical Guidance

How to identify if yours is affected

  1. Verify model number R-410-154 on the device and packaging
  2. Check UDI-DI 00850044399062
  3. Confirm lot numbers fall within shelf life with expiration before 29AUG2026
  4. Ensure the device was distributed for US use (not cleared for US marketing)

Where to find product info

Labeling on device and packaging; recall notification letter from the manufacturer

What timeline to expect

Recall is active as of 2025-08-29. Replacement or refund timelines vary; hospitals should expect coordinated notices by letter.

If the manufacturer is unresponsive

  • Escalate to hospital administration
  • Contact regulatory authorities if manufacturer response is slow
  • Document all communications and store correspondence for records

How to prevent similar issues

  • For future purchases, verify US clearance status before use
  • Implement sterile barrier integrity checks during reprocessing
  • Maintain updated recall contact lists for suppliers and hospitals

Documentation advice

Keep recall letters, model and lot numbers, UDI-DI, and all correspondence with the manufacturer and hospital records.

Product Details

Model No: R-410-154 UDI-DI: 00850044399062 Sold to: US nationwide (CA, FL, IL, KS, LA, MD, MI, MO, NC, NJ, NM, NV, NY, PA, TN, TX, VA) Sold since: Unknown Price: Unknown

Reported Incidents

No injuries or incidents have been reported.

Key Facts

  • 795 units recalled
  • Model No R-410-154
  • UDI-DI 00850044399062
  • Not cleared for US marketing
  • All lot numbers within labeled shelf life with expiration prior to 29AUG2026
  • Distribution: CA, FL, IL, KS, LA, MD, MI, MO, NC, NJ, NM, NV, NY, PA, TN, TX, VA
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
Unknown

Product Details

Model Numbers
R-410-154
R-410-154
Affected States
ALL
Report Date
October 8, 2025
Recall Status
ACTIVE

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