Northeast Scientific recalled 795 units of its Turbo-Elite Laser Atherectomy Catheter on August 29, 2025. The recall follows concerns about breaches in the sterile barrier packaging. This issue compromises the sterility assurance of the device.
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 0.9mm RX Turbo Elite Laser Atherectomy Catheter, Model R-410-154. It was distributed nationwide across various states including California, Florida, and New York. The catheter is not cleared for marketing in the U.S.
The recall highlights a potential for breaches in the sterile barrier packaging. This issue poses a high risk to patients, as compromised sterility can lead to serious infections.
No specific injuries or incidents have been reported related to this recall. The potential for sterility compromise remains a serious concern.
Patients and healthcare providers must stop using the device immediately. Follow the instructions provided in the recall notification letter from Northeast Scientific Inc.
For further information, contact Northeast Scientific Inc. or your healthcare provider. Visit the FDA's website for official recall details.
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