Reprocessed 1.7mm laser atherectomy catheters recalled over sterile barrier breaches
Northeast Scientific is recalling 616 reprocessed 1.7mm RX Turbo Elite laser atherectomy catheters because of potential breaches in the sterile barrier packaging.
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: Scored 3 under the risk-of-harm criterion: a compromised sterile barrier on an intravascular device creates an infection risk, with no injuries reported.
Plain-English summary
NES Reprocessed 1.7mm RX Turbo Elite Laser Atherectomy Catheters, model number R-417-156, are being recalled for potential breaches in the sterile barrier packaging, which compromises sterility assurance. The catheter is indicated for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusions.
The recall covers 616 units carrying UDI-DI 00850044399109, across all lot numbers still within their labelled shelf life. The product was distributed to California, Florida, Illinois, Kansas, Louisiana, Maryland, Michigan, Missouri, North Carolina, New Jersey, New Mexico, Nevada, New York, Pennsylvania, Tennessee, Texas and Virginia. The FDA has classified the action as Class II.
The enforcement record describes a loss of sterility assurance rather than confirmed contamination, and reports no injuries. Facilities should quarantine unexpired stock and follow the firm's instructions.
The recalled product
- Product
- NES Reprocessed 1.7mm RX Turbo Elite Laser Atherectomy Catheter. Model Number: R-417-156. 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 not cle
- Manufacturer
- Northeast Scientific Inc.
- Hazard
- sterile-barrier-breach
- sterility-assurance
- packaging-defect
- 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-417-156
- UDI-DI 00850044399109
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- SevereT-Lok Bone Marrow Tray Kits Recalled for Sterility Testing Failure
FDA (Devices) · 2026-07-22
- SevereMedtronic Bio-Medicus Adult Cannula Kit Recalled for Foreign Material
FDA (Devices) · 2026-07-22
- SevereAbiomed Impella CP Introducer Kit heart pump accessory recall
FDA (Devices) · 2026-07-22
- HighOlympus Toomey Evacuator 50cc with Adaptor sterilization recall
FDA (Devices) · 2026-07-22
- HighVasoview Hemopro 2 Endoscopic Vessel Harvesting System Recall
FDA (Devices) · 2026-07-22