HIGH

Northeast Scientific Recalls Laser Atherectomy Catheter Over Sterility Risk

Northeast Scientific recalled 1,019 units of the 1.4mm RX Turbo Elite Laser Atherectomy Catheter on August 29, 2025. The recall follows concerns about potential breaches in the sterile barrier packaging. The product poses a high hazard level due to compromised sterility assurance.

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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Product Details

The recalled product is the NES Reprocessed 1.4mm RX Turbo Elite Laser Atherectomy Catheter, Model Number R-414-159. It distributed nationwide to states including CA, FL, and NY. The catheter is classified as Class II.

The Hazard

The recall stems from the potential for breaches in the sterile barrier packaging. This compromises the sterility assurance, which can lead to severe health risks during medical procedures.

Reported Incidents

As of the recall date, there have been no reported injuries or incidents related to this device. The potential risks remain high due to the nature of the breach.

What to Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by Northeast Scientific Inc. Contact them or your healthcare provider for detailed instructions.

Contact Information

For questions regarding the recall, contact Northeast Scientific Inc. directly or visit their website for further instructions.

Key Facts

  • Recall Date: August 29, 2025
  • Model Number: R-414-159
  • Quantity: 1,019 units
  • Distribution: Nationwide to multiple states
  • High hazard level due to sterility risk

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Safety Assessment

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

Product Classification

Product Details

Model Numbers
Model No R-414-159
UDI-DI 00850044399123
All Lot Numbers that are within their labeled shelf life with expiration dates prior to 29AUG2026.
Affected States
ALL
Report Date
October 8, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE

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