HIGH

Northeast Scientific Recalled 1,019 Reprocessed Turbo Elite Atherectomy Catheters Over Sterility Bre

Northeast Scientific Corp. recalled 1,019 units of the NES Reprocessed 1.4mm RX Turbo Elite Laser Atherectomy Catheter. The model is not cleared for marketing in the United States. The recall cites potential breaches in sterile barrier packaging that could compromise sterility. Patients and healthcare providers should stop using the device immediately. Follow the manufacturer's recall instructions

Quick Facts at a Glance

Recall Date
August 29, 2025
Hazard Level
HIGH
Brands
Northeast Scientific, NES
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

This reprocessed 1.4mm RX Turbo Elite Laser Atherectomy Catheter is used by interventional cardiologists and vascular surgeons in peripheral arterial interventions to remove plaque from infrainguinal vessels.

Why This Is Dangerous

A breach in sterile barrier packaging could expose the catheter to contaminants, potentially causing infection during or after procedures.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

Hospitals must assess inventory, implement retesting of sterility, and consider alternative devices to avoid infection risks. Users face potential delays in procedures and patient safety concerns.

Practical Guidance

How to identify if yours is affected

  1. Check model number R-414-159.
  2. Verify UDI-DI 00850044399123.
  3. Check shelf life expiration dates prior to 29AUG2026.

Where to find product info

Find serial numbers and UDI on the device label and packaging.

What timeline to expect

Refund/replacement timelines not specified; coordinate with NES and hospital procurement.

If the manufacturer is unresponsive

  • Escalate to regulatory authorities and document correspondence.
  • Consult hospital compliance for recall response.

How to prevent similar issues

  • Verify US clearance status before procurement.
  • Routinely audit sterile barrier packaging integrity.
  • Ensure suppliers provide clear recall notices before use.

Documentation advice

Document product lot numbers, procurement records, and patient exposure history.

Product Details

Model No. R-414-159. UDI-DI 00850044399123. Quantity 1,019 units. Distribution: US nationwide to CA, FL, IL, KS, LA, MD, MI, MO, NC, NJ, NM, NV, NY, PA, TN, TX, VA. Status: ACTIVE. Recall Date: 2025-08-29. Report Date: 2025-10-08. Brand: Northeast Scientific (NES). Category: Medical Devices. Sold as reprocessed device not cleared for US marketing.

Reported Incidents

No specific incidents or injuries are mentioned in the recall notice.

Key Facts

  • 1,019 units recalled
  • Model No R-414-159
  • UDI-DI 00850044399123
  • Shelf life expiration prior to 29AUG2026
  • US nationwide distribution to 15 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
GENERALPREGNANTPETS
Injury Types
POISONINGBURNLACERATIONELECTRICALSUFFOCATIONOTHER

Product Classification

Product TypeAtherectomy Catheter
Sold At
Unknown

Product Details

Model Numbers
R-414-159
UDI-DI 00850044399123
Affected States
ALL
Report Date
October 8, 2025
Recall Status
ACTIVE

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