Northeast Scientific recalled 173 units of the R-414-151 laser atherectomy catheter on August 29, 2025. The recall stems from potential breaches in the sterile packaging, which could compromise sterility assurance. Healthcare providers and patients must stop using the device immediately and follow recall instructions.
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
The recalled product is the NES Reprocessed 1.4mm OTW Turbo Elite Laser Atherectomy Catheter, Model Number R-414-151. This model is not cleared for marketing in the U.S. It was distributed nationwide, with sales reported in states including California, Florida, and Texas.
The recall addresses potential breaches in the sterile barrier packaging of the catheter. Such breaches can lead to compromised sterility, posing a significant health risk.
There are no reported injuries or incidents directly linked to the recalled catheters. However, the potential for compromised sterility presents a high risk for patients.
Patients and healthcare providers should cease use of the catheters immediately. For further instructions, contact Northeast Scientific Inc. or your healthcare provider.
For more information, call Northeast Scientific Inc. or visit their website. Notifications have been sent via letter to affected parties.
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