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Neuroguard IEP System recallZ-0131-2026 · Contego Medical LLC · initiated Sep 4, 2025

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Contego Medical LLC or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Device Design

What the company is doing

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.

Recall details

Recall number
Z-0131-2026
Status
Open, Classified
Initiated by the company
Sep 4, 2025
Posted by the FDA
Oct 10, 2025
Recalling firm
Contego Medical LLC
Quantity
568
Product code
NIM
FDA submissions
P240009
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 description

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

Code information (models, lots, serial numbers)

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)

Devices named in this recall

4 devices in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

4 devices cleared under P240009 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Sources and updates

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