510(k) Report

FDA applicant

InspireMD, Ltd.

Miami1 decision2025–20256 recalls

FDA records 1 decision for InspireMD, Ltd. (Miami) in 2025: 1 original PMA approval. All are in product code NIM (Stent, Carotid). 6 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided InspireMD, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2025: 1
2025high 1 (2025)2026

2026 so far, outlined.

Recalls per year

6in 2026

2026 (partial year): 6
2025high 6 (2026) · low 0 (2025)2026

Class I Class II/III not classified

FIG. 1 — InspireMD, Ltd. by year, 2025–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • NIMStent, Carotid1decision

What has FDA decided for it lately?

  • P240029CGuard Prime Carotid Stent SystemInspireMD, Ltd. · 20256 recalls

The one decision as InspireMD, Ltd. →

What has been recalled?

6 recalls linked to its devices; the latest:

  • P240029Brand Name: CGuard Prime Carotid Stent System, 135cm, 9mx40mm Model/Catalog Number…May 1, 2026Class II
  • P240029CGuard Prime Carotid Stent System, 135cm, 10mmx40mm Model/Catalog Number: CND1040May 1, 2026Class II
  • P240029Brand Name: CGuard Prime Carotid Stent System, 135cm, 8mmx40mm Model/Catalog Number…May 1, 2026Class II
  • P240029CGuard Prime Carotid Stent System, 135cm, 10mmx30mm Model/Catalog Number: CND1030May 1, 2026Class II
  • P240029CGuard Prime Carotid Stent System, 135cm, 9mx30mm Model/Catalog Number: CND0930May 1, 2026Class II
  • P240029Brand Name: CGuard Prime Carotid Stent System, 135cm, 8mmx30mm Model/Catalog Number…May 1, 2026Class II