Laser Atherectomy Catheters Recalled for Potential Sterile Packaging Breaches
Northeast Scientific is recalling 561 NES Reprocessed 0.9mm Turbo Elite Laser Atherectomy Catheters due to potential breaches in the sterile barrier packaging that compromises sterility assurance.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall for a surgical catheter with potential sterile barrier breaches in packaging. The source text does not report any illnesses or injuries, fitting the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Northeast Scientific Inc. is recalling 561 units of the NES Reprocessed 0.9mm OTW Turbo Elite Laser Atherectomy Catheter (Model R-410-152). The device is indicated for use in the treatment of infrainguinal stenoses and occlusions. The recall affects all lot numbers within their labeled shelf life with expiration dates prior to August 29, 2026.
The devices are being recalled due to potential for breaches in the sterile barrier packaging. Such breaches compromise the sterility assurance of the medical device.
The recalled devices were distributed nationwide to the following states: California, Florida, Illinois, Kansas, Louisiana, Maryland, Michigan, Missouri, North Carolina, New Jersey, New Mexico, Nevada, New York, Pennsylvania, Tennessee, Texas, and Virginia.
Healthcare providers and hospitals that have received these devices should verify the model number and lot numbers against this recall notice. Affected devices should not be used and should be returned to the manufacturer.
The recalled product
- Product
- NES Reprocessed 0.9mm OTW Turbo Elite Laser Atherectomy Catheter. Model Number: R-410-152. The NES Reprocessed Turbo-Elite Laser Atherectomy Catheter is indicated for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusions.
- Manufacturer
- Northeast Scientific Inc.
- Hazard
- sterile-barrier-breach
- contamination-risk
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Model No R-410-152
- UDI-DI 00850044399055
Distribution
Distributed nationwide across the United States.
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