| | Class 2 Device Recall NES Reprocessed 2.0mm RX Turbo Elite Laser Atherectomy Catheter |  |
| Date Initiated by Firm | August 29, 2025 |
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| Date Posted | October 02, 2025 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-0025-2026 |
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| Recall Event ID |
97524 |
| Product Classification |
Reprocessed Atherectomy Catheter - Product Code QTF
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| Product | NES Reprocessed 2.0mm RX Turbo Elite Laser Atherectomy Catheter. Model Number: R-420-159.
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. |
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| Code Information |
Model No R-420-159; UDI-DI 00850044399086; All Lot Numbers that are within their labeled shelf life with expiration dates prior to 29AUG2026.
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Recalling Firm/
Manufacturer |
Northeast Scientific Inc.
2142 Thomaston Ave
Waterbury CT 06704-1013
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| For Additional Information Contact | Stephen Miller
1-203-7562111 Ext. 112 |
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Manufacturer Reason
for Recall | Potential for breaches in the sterile barrier packaging, compromising sterility assurance. |
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FDA Determined
Cause 2 | Process control |
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| Action | Northeast 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. |
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| Quantity in Commerce | 141 units |
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| Distribution | US Nationwide distribution to CA, FL, IL, KS, LA, MD, MI, MO, NC, NJ, NM, NV, NY, PA, TN, TX, VA. |
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| Total Product Life Cycle | TPLC Device Report |
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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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