FDA Inspection
Medtronic Perfusion SystemsMedtronic Perfusion Systems – FDA Inspection, Sep 30, 2016
Record Details
This FDA Inspection record concerns Medtronic Perfusion Systems, with an inspection on September 30, 2016, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Medtronic Perfusion Systems
- Inspection Date
- September 30, 2016
- Product Type
- Devices
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ID · 824b6add-4362-4992-9175-dec9fc4a088f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 987452
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Medtronic Perfusion Systems
7| Date | Classification | Office | Project area |
|---|---|---|---|
| June 23, 2022 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 24, 2014 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 12, 2014 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| April 1, 2013 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| January 23, 2012 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
Other documents for Medtronic Perfusion Systems
- FDA Inspection 1178299 - 2022-06-23
- FDA Inspection 886720 - 2014-06-24
- FDA Inspection 867900 - 2014-02-12
- FDA Inspection 831904 - 2013-04-01
- FDA Inspection 764709 - 2012-01-23
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