Z-0019-2026Class II

NES Reprocessed 1.4mm OTW Turbo Elite Laser Atherectomy Catheter. Model Number: R-414-151. The NES...

Name: Z-0019-2026 NES Reprocessed 1.4mm OTW Turbo Elite Laser Atherectomy Catheter. Model Number: R-414-151. The NES...
Creator: Northeast Scientific Inc.
Published: 2025-08-29
License: https://open.fda.gov/license/

Northeast Scientific Inc. / initiated 2025-08-29 / Open, Classified / root cause: manufacturing process

FDA source

Northeast Scientific Inc. began a recall of NES Reprocessed 1.4mm OTW Turbo Elite Laser Atherectomy Catheter. Model Number: R-414-151. The NES Reprocessed Turbo-Elite Laser Atherectomy Catheter is... on 2025-08-29. FDA classified it as Class II and gives the reason as "Potential for breaches in the sterile barrier packaging, compromising sterility assurance". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0019-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-08-29
Posted: 2025-10-02
Recalling firm: Northeast Scientific Inc.
Product: NES Reprocessed 1.4mm OTW Turbo Elite Laser Atherectomy Catheter. Model Number: R-414-151. 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.
Product code: QTF Reprocessed Atherectomy Catheter
Reason for recall: Potential for breaches in the sterile barrier packaging, compromising sterility assurance.
Root cause tag: manufacturing process
FDA root cause: Process control
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 [email protected] or 203-756-2111.
Quantity in commerce: 173 units
Distribution: US Nationwide distribution to CA, FL, IL, KS, LA, MD, MI, MO, NC, NJ, NM, NV, NY, PA, TN, TX, VA.
Product codes and lots: Model No R-414-151; UDI-DI 00850044399116; All Lot Numbers that are within their labeled shelf life with expiration dates prior to 29AUG2026

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0019-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0018-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-10-08	2025-10-02
Z-0019-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-10-08	2025-10-02
Z-0020-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-10-08	2025-10-02
Z-0021-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-10-08	2025-10-02
Z-0022-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-10-08	2025-10-02
Z-0023-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-10-08	2025-10-02
Z-0024-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-10-08	2025-10-02
Z-0025-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-10-08	2025-10-02

Product code QTF

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)