What is the most recent FDA action on file for INSPIREMD Inc?

June 17, 2026. Argus HQ ingests new FDA enforcement records daily.

Has INSPIREMD Inc had product recalls?

Yes, 6 recalls on file. See the full history below for each one.

Is this FDA enforcement data for INSPIREMD Inc official?

Every record links directly to its primary FDA.gov source. Argus HQ aggregates and structures public FDA data; the verbatim FDA record is always the source of truth.

How many FDA actions has INSPIREMD Inc had?

Argus HQ has recorded 6 FDA events for INSPIREMD Inc: 0 warning letters, 6 recalls, 0 approvals, and 0 Form 483 inspection observations. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures.

INSPIREMD Inc's Complete FDA Record

FDA action counts

Total FDA actions	6
Warning letters	0
Recalls	6
Approval records	0
Form 483 inspection citations	0
Most recent action	June 17, 2026

Key takeaway: Argus HQ has recorded 6 FDA events for INSPIREMD Inc: 0 warning letters, 6 recalls, 0 approvals, and 0 inspection 483 observations. These events span from 2026-06-17 to 2026-06-17. The most severe rating Argus HQ has assigned across this history is "high". Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures. This page reflects only the FDA event types Argus HQ currently tracks -- FDA Warning Letters, recalls, drug and biologic approvals, and Form 483 inspection observations -- and will update automatically as new FDA records are observed.

Risk pattern analysis

Argus HQ analysis — not an FDA finding

This section is Argus HQ analysis, not an FDA finding. INSPIREMD Inc has 6 separate FDA recalls on file, more than a single isolated recall event. A pattern across multiple FDA touchpoints does not by itself establish that any specific product currently poses a risk; it reflects only the frequency of FDA engagement with this company as recorded in Argus HQ's database. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures. This page reflects only the FDA event types Argus HQ currently tracks -- FDA Warning Letters, recalls, drug and biologic approvals, and Form 483 inspection observations -- and will update automatically as new FDA records are observed. Argus HQ does not independently verify FDA's underlying findings; this page summarizes what FDA has published and links back to the original FDA source for each event.

Enforcement history

On 2026-06-17, Argus HQ recorded a FDA recall for INSPIREMD Inc, rated "high" severity in Argus HQ's classification: INSPIREMD Inc — Class II recall: Brand Name: CGuard¿ Prime Carotid Stent System, 135cm, 8mmx30mm Model/Catalog N… An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA requirements. On 2026-06-17, Argus HQ recorded a FDA recall for INSPIREMD Inc, rated "high" severity in Argus HQ's classification: INSPIREMD Inc — Class II recall: CGuard Prime Carotid Stent System, 135cm, 9mx30mm Model/Catalog Number: CND093… An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA requirements. On 2026-06-17, Argus HQ recorded a FDA recall for INSPIREMD Inc, rated "high" severity in Argus HQ's classification: INSPIREMD Inc — Class II recall: Brand Name: CGuard¿ Prime Carotid Stent System, 135cm, 8mmx40mm Model/Catalog N… An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA requirements. On 2026-06-17, Argus HQ recorded a FDA recall for INSPIREMD Inc, rated "high" severity in Argus HQ's classification: INSPIREMD Inc — Class II recall: Brand Name: CGuard Prime Carotid Stent System, 135cm, 9mx40mm Model/Catalog Num… An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA requirements. On 2026-06-17, Argus HQ recorded a FDA recall for INSPIREMD Inc, rated "high" severity in Argus HQ's classification: INSPIREMD Inc — Class II recall: CGuard Prime Carotid Stent System, 135cm, 10mmx30mm Model/Catalog Number: CND1… An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA requirements. On 2026-06-17, Argus HQ recorded a FDA recall for INSPIREMD Inc, rated "high" severity in Argus HQ's classification: INSPIREMD Inc — Class II recall: CGuard¿ Prime Carotid Stent System, 135cm, 10mmx40mm Model/Catalog Number: CND… An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA requirements. In total, INSPIREMD Inc has 6 FDA events on file with Argus HQ across the sources Argus HQ currently tracks (FDA Warning Letters, recalls, drug/biologic approvals, and Form 483 inspection observations).

Frequently asked questions

What is the most recent FDA action on file for INSPIREMD Inc?: June 17, 2026. Argus HQ ingests new FDA enforcement records daily.
Has INSPIREMD Inc had product recalls?: Yes, 6 recalls on file. See the full history below for each one.
Is this FDA enforcement data for INSPIREMD Inc official?: Every record links directly to its primary FDA.gov source. Argus HQ aggregates and structures public FDA data; the verbatim FDA record is always the source of truth.
How many FDA actions has INSPIREMD Inc had?: Argus HQ has recorded 6 FDA events for INSPIREMD Inc: 0 warning letters, 6 recalls, 0 approvals, and 0 Form 483 inspection observations. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures.

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Compiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder

Cite this record

Reusing this data in reporting or research? Here’s a ready-made citation.

APA

Argus HQ Research (2026). INSPIREMD Inc's Complete FDA Record. Digital Empire LLC. Retrieved from https://argushq.ai/company/inspiremd-inc

MLA

"INSPIREMD Inc's Complete FDA Record." Argus HQ Research, Digital Empire LLC, 2026, argushq.ai/company/inspiremd-inc.

Chicago

Argus HQ Research. "INSPIREMD Inc's Complete FDA Record." Digital Empire LLC. Accessed July 13, 2026. https://argushq.ai/company/inspiremd-inc.

BibTeX

@misc{argushq_argushq_ai_company_inspiremd_inc_2026,
  title = {INSPIREMD Inc's Complete FDA Record},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire LLC},
  url = {https://argushq.ai/company/inspiremd-inc},
  note = {Accessed: July 13, 2026}
}

Source: FDA.gov (aggregated across Warning Letters, Recalls, Approvals, Form 483s) ↗