FDA action counts (Argus HQ database)
| Total tracked FDA actions | 46 |
|---|---|
| Recalls | 46 |
| Warning letters | 0 |
| Form 483 inspection citations | 0 |
| Most recent tracked action | July 1, 2026 |
| Most severe rating on file | critical |
Recall severity breakdown
Computed from all 46 tracked recalls. FDA classifies each recall Class I (most serious), II, or III on the underlying record; Argus HQ maps that to critical/high/medium/low severity buckets.
| high | 42 (91.3%) |
|---|---|
| critical | 4 (8.7%) |
Recall velocity by month
Months with at least one tracked recall for Medtronic Perfusion Systems, oldest to most recent. Gaps indicate months with zero tracked recalls, not missing data.
| Month | Recalls |
|---|---|
| 2023-02 | 6 |
| 2024-03 | 1 |
| 2024-05 | 13 |
| 2024-07 | 1 |
| 2024-09 | 1 |
| 2024-11 | 1 |
| 2025-01 | 3 |
| 2025-03 | 1 |
| 2025-09 | 3 |
| 2025-11 | 3 |
| 2026-03 | 1 |
| 2026-05 | 9 |
| 2026-07 | 3 |
Recurring recall-reason patterns
Argus HQ keyword-matched the free-text “reason for recall” field on each tracked record into categories below. FDA does not publish a structured reason code for device recalls, so this is Argus HQ’s own pattern analysis, not an official FDA classification — records that don’t match a listed keyword fall into “Other.”
| Sterility | 23 recalls |
|---|---|
| Other / not pattern-matched | 17 recalls |
| Labeling | 6 recalls |
Full recall history (46)
Most recent first. Every row links to its Argus HQ record and FDA.gov source.
Coverage
No independent news coverage was found for Medtronic Perfusion Systems’s FDA recall history at the time this page was published — its enforcement record is small enough that it hasn’t drawn trade-press attention. This page is the most complete public record available.
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Related enforcement actions
Full FDA history for Medtronic Perfusion Systems- Medtronic Perfusion Systems — Class II recall: Octopus Evolution Tissue Stabilizer, Model TS2000 →
- Medtronic Perfusion Systems — Class II recall: Octopus Evolution AS Tissue Stabilizer, Model TS2500 →
- Medtronic Perfusion Systems — Class II recall: Octopus 4 Tissue Stabilizer, Model 29400 →
- Medtronic Perfusion Systems — Class II recall: Medtronic GUNDRY Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 9… →
- 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 DLP Retrograde Cannula Manual-Inflate Silicone Body 13FR, 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… →
Other enforcement deep dives
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- Zimmer, Inc.: FDA enforcement history →
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- B. Braun Medical Inc.: FDA enforcement history →
- Fresenius Kabi USA, LLC: FDA enforcement history →
- CareFusion 213, LLC: FDA enforcement history →
- Windstone Medical Packaging, Inc.: FDA enforcement history →
- Siemens Medical Solutions USA, Inc.: FDA enforcement history →
- GE Medical Systems, LLC: FDA enforcement history →
- Olympus Corporation of the Americas: FDA enforcement history →
- Abiomed, Inc.: FDA enforcement history →
- Dabur India Limited: FDA enforcement history →
- AVID Medical, Inc.: FDA enforcement history →
- DePuy (Ireland): FDA enforcement history →
- Wells Pharma of Houston LLC: FDA enforcement history →
- GE Medical Systems Information Technologies Inc: FDA enforcement history →
- Amgen, Inc.: FDA enforcement history →
- Elekta, Inc.: FDA enforcement history →
- Covidien LLC: FDA enforcement history →
Compiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder
Verified from FDA.gov · Last updated: Jul 1, 2026Cite this record
Reusing this data in reporting or research? Here’s a ready-made citation.
Argus HQ Research (2026). Medtronic Perfusion Systems: FDA Enforcement History. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/enforcement/medtronic-perfusion-systems
"Medtronic Perfusion Systems: FDA Enforcement History." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/enforcement/medtronic-perfusion-systems.
Argus HQ Research. "Medtronic Perfusion Systems: FDA Enforcement History." Digital Empire Holdings LLC. Accessed July 24, 2026. https://argushq.ai/enforcement/medtronic-perfusion-systems.
@misc{argushq_argushq_ai_enforcement_medtronic_perfusion_systems_2026,
title = {Medtronic Perfusion Systems: FDA Enforcement History},
author = {{Argus HQ Research}},
year = {2026},
publisher = {Digital Empire Holdings LLC},
url = {https://argushq.ai/enforcement/medtronic-perfusion-systems},
note = {Accessed: July 24, 2026}
}