Medical Catheter Recalled for Potential Sterile Barrier Packaging Breaches
Northeast Scientific is recalling 795 units of the NES Reprocessed 0.9mm RX Turbo Elite Laser Atherectomy Catheter due to potential breaches in sterile barrier packaging that could compromise device sterility.
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 medical device recall involving potential compromise of sterile barrier packaging on surgical equipment. Although no illnesses or injuries have been reported, the loss of sterility assurance in a surgical catheter presents a risk of harm, particularly infection, making this a High severity issue per the rubric.
Plain-English summary
Northeast Scientific Inc. is recalling 795 units of the NES Reprocessed 0.9mm RX Turbo Elite Laser Atherectomy Catheter, Model R-410-154, due to potential breaches in the sterile barrier packaging that could compromise sterility assurance.
The affected units were distributed nationwide to hospitals and medical facilities in 16 states: California, Florida, Illinois, Kansas, Louisiana, Maryland, Michigan, Missouri, North Carolina, New Jersey, New Mexico, Nevada, New York, Pennsylvania, Tennessee, Texas, and Virginia. All lot numbers within their labeled shelf life with expiration dates prior to August 29, 2026 are included in the recall.
The catheter is a surgical device indicated for the treatment of infrainguinal stenoses and occlusions, including atherectomy procedures. Breaches in the sterile barrier packaging can allow contamination of the device, potentially increasing the risk of infection when used during vascular intervention procedures.
Northeast Scientific has not reported any illnesses or injuries associated with this issue. Medical facilities with affected units should identify and quarantine the devices and contact Northeast Scientific for replacement or return instructions.
The recalled product
- Product
- NES Reprocessed 0.9mm RX Turbo Elite Laser Atherectomy Catheter. Model/Catalog Number: R-410-154. The NES Reprocessed Turbo-Elite Laser Atherectomy Catheter is indicated for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusions. This model is
- Manufacturer
- Northeast Scientific Inc.
- Hazard
- sterility-breach
- infection-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-410-154
- UDI-DI 00850044399062
Distribution
Distributed nationwide across the United States.
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