FDA action counts
| Total FDA actions | 12 |
|---|---|
| Warning letters | 0 |
| Recalls | 12 |
| Approval records | 0 |
| Form 483 inspection citations | 0 |
| Most recent action | July 1, 2026 |
Enforcement history
On 2026-05-27, Argus HQ recorded a FDA recall for Medtronic Perfusion Systems, rated "high" severity in Argus HQ's classification: Medtronic Perfusion Systems — Class II recall: Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94… An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA requirements. On 2026-05-27, Argus HQ recorded a FDA recall for Medtronic Perfusion Systems, rated "high" severity in Argus HQ's classification: Medtronic Perfusion Systems — Class II recall: Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94… An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA requirements. On 2026-05-27, Argus HQ recorded a FDA recall for Medtronic Perfusion Systems, rated "high" severity in Argus HQ's classification: Medtronic Perfusion Systems — Class II recall: Medtronic GUNDRY Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 9… An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA requirements. On 2026-05-27, Argus HQ recorded a FDA recall for Medtronic Perfusion Systems, rated "high" severity in Argus HQ's classification: Medtronic Perfusion Systems — Class II recall: Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94… An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA requirements. On 2026-05-27, Argus HQ recorded a FDA recall for Medtronic Perfusion Systems, rated "high" severity in Argus HQ's classification: Medtronic Perfusion Systems — Class II recall: Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94… An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA requirements. On 2026-05-27, Argus HQ recorded a FDA recall for Medtronic Perfusion Systems, rated "high" severity in Argus HQ's classification: Medtronic Perfusion Systems — Class II recall: Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94… An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA requirements. On 2026-05-27, Argus HQ recorded a FDA recall for Medtronic Perfusion Systems, rated "high" severity in Argus HQ's classification: Medtronic Perfusion Systems — Class II recall: Medtronic GUNDRY Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model… An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA requirements. On 2026-05-27, Argus HQ recorded a FDA recall for Medtronic Perfusion Systems, rated "high" severity in Argus HQ's classification: Medtronic Perfusion Systems — Class II recall: Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94… An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA requirements. On 2026-05-27, Argus HQ recorded a FDA recall for Medtronic Perfusion Systems, rated "high" severity in Argus HQ's classification: Medtronic Perfusion Systems — Class II recall: Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94… An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA requirements. On 2026-07-01, Argus HQ recorded a FDA recall for Medtronic Perfusion Systems, rated "high" severity in Argus HQ's classification.
Risk pattern analysis
Argus HQ analysis — not an FDA finding
This section is Argus HQ analysis, not an FDA finding. Medtronic Perfusion Systems has 12 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.
Frequently asked questions
- What is the most recent FDA action against Medtronic Perfusion Systems?
- The most recent FDA event Argus HQ has on file for Medtronic Perfusion Systems is dated 2026-07-01, with a severity rating of "high" in Argus HQ's classification. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures.
- Does Argus HQ track new FDA actions for Medtronic Perfusion Systems automatically?
- Yes. Argus HQ ingests FDA sources daily, including FDA warning letters, recalls, drug and biologic approvals, and Form 483 inspection observations. When a new FDA action linked to Medtronic Perfusion Systems is observed, this page's event count and history update automatically.
- How many FDA actions does Argus HQ track for Medtronic Perfusion Systems?
- 12 total: 0 warning letters, 12 recalls, 0 approval records, and 0 Form 483 inspection citations.
- What is the most recent FDA action on file for Medtronic Perfusion Systems?
- July 1, 2026. Argus HQ ingests new FDA enforcement records daily.
Every FDA action tied to this company, the week it happens.
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Related enforcement actions
- Medtronic Perfusion Systems — Class II recall: Octopus Evolution Tissue Stabilizer, Model TS2000 →
- Medtronic Perfusion Systems — Class II recall: Octopus 4 Tissue Stabilizer, Model 29400 →
- Medtronic Perfusion Systems — Class II recall: Octopus Evolution AS Tissue Stabilizer, Model TS2500 →
- Medtronic Perfusion Systems — Class II recall: Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94… →
- Medtronic Perfusion Systems — Class II recall: Medtronic GUNDRY Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model… →
- Medtronic Perfusion Systems — Class II recall: Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94… →
- Medtronic Perfusion Systems — Class II recall: Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94… →
- Medtronic Perfusion Systems — Class II recall: Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94… →
- Medtronic Perfusion Systems — Class II recall: Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94… →
- Medtronic Perfusion Systems — Class II recall: Medtronic GUNDRY Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 9… →
Compare with
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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.
Argus HQ Research (2026). Regulatory Record: Medtronic Perfusion Systems. Digital Empire LLC. Retrieved from https://argushq.ai/company/medtronic-perfusion-systems
"Regulatory Record: Medtronic Perfusion Systems." Argus HQ Research, Digital Empire LLC, 2026, argushq.ai/company/medtronic-perfusion-systems.
Argus HQ Research. "Regulatory Record: Medtronic Perfusion Systems." Digital Empire LLC. Accessed July 13, 2026. https://argushq.ai/company/medtronic-perfusion-systems.
@misc{argushq_argushq_ai_company_medtronic_perfusion_systems_2026,
title = {Regulatory Record: Medtronic Perfusion Systems},
author = {{Argus HQ Research}},
year = {2026},
publisher = {Digital Empire LLC},
url = {https://argushq.ai/company/medtronic-perfusion-systems},
note = {Accessed: July 13, 2026}
}Source: FDA.gov (aggregated across Warning Letters, Recalls, Approvals, Form 483s) ↗