NES Turbo Elite 1.4mm Catheter (Northeast Scientific) – Sterility Breach (2025)
Sterile barrier packaging breaches can potentially compromise medical device sterility.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
NES Reprocessed 1.4mm RX Turbo Elite Laser Atherectomy Catheter. Model Number: R-414-159. 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.
Brand
Northeast Scientific Inc.
Lot Codes / Batch Numbers
Model No R-414-159, UDI-DI 00850044399123, All Lot Numbers that are within their labeled shelf life with expiration dates prior to 29AUG2026.
Products Sold
Model No R-414-159; UDI-DI 00850044399123; All Lot Numbers that are within their labeled shelf life with expiration dates prior to 29AUG2026.
Northeast Scientific Inc. is recalling NES Reprocessed 1.4mm RX Turbo Elite Laser Atherectomy Catheter. Model Number: R-414-159. The NES R due to Potential for breaches in the sterile barrier packaging, compromising sterility assurance.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Potential for breaches in the sterile barrier packaging, compromising sterility assurance.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026