FDA Medical Device Recalls (openFDA)
INSPIREMD Inc: Brand Name: CGuard Prime Carotid Stent System, 135cm, 8mmx40mm Model/Catalog Number: CND0840
- Recall number
- Z-2326-2026
- Recalling firm
- INSPIREMD Inc
- Product
- Brand Name: CGuard Prime Carotid Stent System, 135cm, 8mmx40mm Model/Catalog Number: CND0840
- Status
- Open, Classified
- Initiated
- 2026-05-01
- Posted
- 2026-06-05
- Terminated
- not on file
- Reason
- Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.
- Root cause
- Component design/selection
- Action
- On May 1, 2026, InspireMD, Inc. issued a Urgent Medical Device Recall notification to affected consignees. InspireMD asked consignees to take the following actions: 1. Cease further use of all affected CGuard Prime Carotid Stent Systems identified by the model numbers listed in the letter. 2. Quarantine and segregate all affected units currently in your inventory. Place affected product in a clearly labeled quarantine area to prevent inadvertent use. 3. This notice needs to be passed on to all those who need to be aware within your organization or facilities where the affected devices have been transferred. 4. Please retain a copy of this letter, and keep a copy of the Acknowledgement Form. 5. Complete the attached Acknowledgement Form and return it by email to USSupport@inspiremd.com within 2 business days. 6. InspireMD will contact each affected customer to facilitate the return and disposition process.
- Quantity
- 424 units
- Distribution
- US Nationwide distribution in the states of AR, AZ, CA, DC, FL, GA, HI, IL, IN, KS, MA, MD, MI, MO, NC, NJ, NV, NY, OH, OR, RI, SD, TN, TX, VA, WA, WI, WV.
- Lot, serial or model codes
- UDI: 07290120281707; all lots/serial numbers manufactured between 02/03/2025 and 02/23/2026
- 510(k) numbers
- not on file
- PMA numbers
- ["P240029"]
- Product code
- NIM
- Firm FEI
- 3032814119
- Firm city
- Miami
- Firm state
- FL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28