Z-0131-2026Class II

Neuroguard IEP 3 in 1 Carotid Stent and Post-Dilation Balloon System with Integrated Embolic Protection...

Name: Z-0131-2026 Neuroguard IEP 3 in 1 Carotid Stent and Post-Dilation Balloon System with Integrated Embolic Protection...
Creator: Contego Medical LLC
Published: 2025-09-04
License: https://open.fda.gov/license/

Contego Medical, Inc / initiated 2025-09-04 / Open, Classified / root cause: design

FDA source

Contego Medical LLC began a recall of Neuroguard IEP 3 in 1 Carotid Stent and Post-Dilation Balloon System with Integrated Embolic Protection (Neuroguard IEP System), REF: NG-0740-140-2... on 2025-09-04. FDA classified it as Class II and gives the reason as "Carotid stent and post-dilation balloon system with integrated embolic protection system has an integrated filter that may not open or may not fully open during sheath retraction and operation of the filter knob. The...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-0131-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-09-04
Posted: 2025-10-10
Recalling firm: Contego Medical, Inc
Product: Neuroguard IEP 3 in 1 Carotid Stent and Post-Dilation Balloon System with Integrated Embolic Protection (Neuroguard IEP System), REF: NG-0740-140-2, NG-NV-7-40, NG-0640-140-2, NG-NV-6-40
Product code: NIM Stent, Carotid
Reason for recall: Carotid stent and post-dilation balloon system with integrated embolic protection system has an integrated filter that may not open or may not fully open during sheath retraction and operation of the filter knob. The stent is used with a primary distal embolic protection device.
Root cause tag: design
FDA root cause: Device Design
Action: On 9/4/2025, communication and training to the field representatives started with in person letter distribution following immediately after. Customers were asked to do the following: Action Required 1) Inventory Check: Medtronic and Contego sales representatives will visit your facility to conduct an inventory count of devices from the affected lots. 2) Quarantine Affected Devices: Any identified devices will be removed from use and quarantined by the Medtronic or Contego team. 3) Return: Medtronic and Contego will remove affected devices. If replacements are desired, they can be provided during the same visit. 4) Confirmation: Sign and return the enclosed acknowledgment form to confirm receipt of this advisory and the completion of actions performed by Medtronic or Contego. 5) Please email the completed form to Contego Medical [email protected] as soon as possible and retain a copy of the form to provide to the representative at the time of their visit. If you have questions, contact the firm's Recall Support Team at [email protected] or call 919-459-7250 Extension 4.
Quantity in commerce: 568
Distribution: US Nationwide distribution in the states of FL, CO, CA, IL, NC, KY, TX, PA, DE, NJ, IN, NY, OH, LA, OK, SC, CT, WI, MA, KS, UT, MD, AL.
Product codes and lots: REF/UDI-DI/Lot(Expiration): NG-0740-140-2/00851616007613/Z2460707D(Z2460707D), Z2460733A(03/05/2027), Z2460766A(04/07/2027), Z2460774B(04/17/2027), Z2460780A(04/18/2027); NG-0640-140-2/00851616007590/Z2460746C(03/20/2027), Z2460774A(04/18/2027); NG-NV-7-40/00851616007620/Z2460776D(04/14/2027); NG-NV-6-40/00851616007651/Z2460776B(04/16/2027)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0131-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0131-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-10-22	2025-10-10

Product code NIM

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)