Northeast Scientific recalled 561 units of its Turbo Elite Laser Atherectomy Catheter on August 29, 2025. The recall follows concerns about breaches in the sterile barrier packaging. This could compromise the sterility assurance necessary for medical use.
Potential for breaches in the sterile barrier packaging, compromising sterility assurance.
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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The recalled product is the NES Reprocessed 0.9mm OTW Turbo Elite Laser Atherectomy Catheter, Model Number R-410-152. It has been distributed nationwide in the U.S., including states like California, Florida, and Texas.
The recall is due to potential breaches in the sterile barrier packaging. This defect poses a high risk to patients as it could lead to infections or other complications.
No specific injuries or incidents have been reported in this recall. The high hazard level indicates potential serious risks.
Patients and healthcare providers should stop using the device immediately. Follow the recall instructions provided by the manufacturer and contact Northeast Scientific Inc. for further guidance.
For more information, contact Northeast Scientific Inc. or visit the FDA website at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-0018-2026.
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