HIGH

Northeast Scientific Recalled 561 Units of NES Reprocessed 0.9mm OTW Turbo Elite Laser Atherectomy C

Northeast Scientific recalled 561 units of NES Reprocessed 0.9mm OTW Turbo Elite Laser Atherectomy Catheter. The recall covers all lots within shelf life ending before August 29, 2026. The hazard is breaches in sterile barrier packaging that could compromise sterility. Stop using the device and follow manufacturer instructions for return or replacement.

Quick Facts at a Glance

Recall Date
August 29, 2025
Hazard Level
HIGH
Brands
Northeast Scientific, NES Reprocessed
Category
Health & Personal Care
Sold At
Unknown
Geographic Scope
1 states
At-Risk Groups
GENERAL, PREGNANT, PETS

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

Laser atherectomy catheters are used in endovascular procedures to treat infrainguinal stenoses and occlusions. Reprocessing of devices involves cleaning and re-sterilization for reuse in healthcare settings.

Why This Is Dangerous

A breached sterile barrier can lead to contamination and infection risk for patients undergoing procedures with the catheter.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

The recall focuses on sterility risk rather than immediate device malfunction. Affected facilities must implement recall procedures and monitor for potential post-procedure infections.

Practical Guidance

How to identify if yours is affected

  1. Check Model R-410-152.
  2. Verify UDI-DI 00850044399055.
  3. Confirm shelf life date not past 29AUG2026.

Where to find product info

Model numbers and UDI codes are on device packaging and labeling.

What timeline to expect

Recall processing and refunds/replacements may take several weeks.

If the manufacturer is unresponsive

  • Document all communications with the vendor.
  • Escalate to hospital risk management or regulatory bodies if the vendor is unresponsive.

How to prevent similar issues

  • Ensure sterile barrier integrity during packaging and re-sterilization processes.
  • Follow manufacturer reprocessing guidelines.
  • Verify packaging before use in any endovascular procedure.

Documentation advice

Keep recall letter, packaging, lot numbers, and any healthcare facility communications; photograph packaging seals and labels.

Product Details

Model No R-410-152. UDI-DI 00850044399055. Distribution: US nationwide to CA, FL, IL, KS, LA, MD, MI, MO, NC, NJ, NM, NV, NY, PA, TN, TX, VA. Quantity: 561 units. Sold/used in medical settings prior to recall date 2025-08-29.

Reported Incidents

No specific injuries or incidents were reported in the recall notice.

Key Facts

  • 561 units recalled
  • Model No R-410-152
  • UDI-DI 00850044399055
  • Shelf life through 29AUG2026
  • US nationwide distribution to listed states
  • Sterile barrier breach could compromise sterility
View Original Recall on FDA - Medical Devices

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Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: What to Do When You Find a Recalled Product

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERALPREGNANTPETS
Injury Types
ELECTRICALLACERATIONPOISONINGSUFFOCATIONOTHER

Product Classification

Product TypeLaser Atherectomy Catheter
Sold At
Unknown

Product Details

Model Numbers
R-410-152
UDI-DI 00850044399055
Affected States
ALL
Report Date
October 8, 2025
Recall Status
ACTIVE

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