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U.S. Department of Health and Human Services

Class 2 Device Recall NES Reprocessed 0.9mm RX Turbo Elite Laser Atherectomy Catheter

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 Class 2 Device Recall NES Reprocessed 0.9mm RX Turbo Elite Laser Atherectomy Cathetersee related information
Date Initiated by FirmAugust 29, 2025
Date PostedOctober 02, 2025
Recall Status1 Open3, Classified
Recall NumberZ-0022-2026
Recall Event ID 97524
Product Classification Reprocessed Atherectomy Catheter - Product Code QTF
ProductNES 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 not cleared for marketing in the US.
Code Information Model No R-410-154; UDI-DI 00850044399062; All Lot Numbers that are within their labeled shelf life with expiration dates prior to 29AUG2026.
Recalling Firm/
Manufacturer		 Northeast Scientific Inc.
2142 Thomaston Ave
Waterbury CT 06704-1013
For Additional Information ContactStephen Miller
1-203-7562111 Ext. 112
Manufacturer Reason
for Recall		Potential for breaches in the sterile barrier packaging, compromising sterility assurance.
FDA Determined
Cause 2		Process control
ActionNortheast Scientific notified consignees via an "URGENT: Medical Device Recall Notification" letter dated 8/29/2025 and email. Consignees were instructed to immediately discontinue use of affected products, quarantine and return any unused affected units, and complete and return the enclosed Recall Response Form, even if you no longer have any affected product. If product were further distributed, consignees were instructed to notify those customers immediately and ensure they also discontinue use and return the devices. Northeast Scientific will provide replacement product (if available) or credit for returned product. In addition, Northeast Scientific has initiated an investigation and is implementing corrective actions to prevent recurrence. If you have any questions or concerns, please reach out to your Northeast Scientific Sales Representative or contact us at Sales@nescientific.com or 203-756-2111.
Quantity in Commerce795 units
DistributionUS Nationwide distribution to CA, FL, IL, KS, LA, MD, MI, MO, NC, NJ, NM, NV, NY, PA, TN, TX, VA.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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