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Medtronic Perfusion Systems

United Statesfrom the FDA registration address FDA establishment FEI 1718389

Devices
29
Registrations
FDA
FDA recalls
13050 ongoing since 2021 (52 open in total)
2 open since before 2021

Catalogue29

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Company details

FDA FEI number
1718389
Address
18501 E Plaza Dr, PARKER, CO, 80134

FDA recalls130

Recalls are matched to the firm by name. FDA recall data as of 22 Oct 2026.

Recalls initiated per year

  • 2017 5
  • 2018 7
  • 2019 1
  • 2020 0
  • 2021 41
  • 2022 7
  • 2023 0
  • 2024 20
  • 2025 7
  • 2026 10

32 initiated before 2017

Showing the 10 most recent of 130 recalls.

  • 2026

    • 21 Apr 2026 Z-2214-2026 Class II Ongoing Certain lots of product have the potential for a sterile barrier breach. Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Canada, China, Colombia, Costa…
      Full distribution text Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Canada, China, Colombia, Costa Rica, Cyprus, Denmark, France, Germany, Hong Kong, Hungary, Italy, Japan, Latvia, Lithuania, Malaysia, Moldova, Republic Of, Morocco, Netherlands, Norway, Panama, Poland, Russia, Serbia, Singapore, South Africa, South Korea, Spain, Suriname, Sweden, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, United States, Uruguay, Vietnam.
      Submission numbers: K860149, K953945
    • 21 Apr 2026 Z-2215-2026 Class II Ongoing Certain lots of product have the potential for a sterile barrier breach. Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Canada, China, Colombia, Costa…
      Full distribution text Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Canada, China, Colombia, Costa Rica, Cyprus, Denmark, France, Germany, Hong Kong, Hungary, Italy, Japan, Latvia, Lithuania, Malaysia, Moldova, Republic Of, Morocco, Netherlands, Norway, Panama, Poland, Russia, Serbia, Singapore, South Africa, South Korea, Spain, Suriname, Sweden, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, United States, Uruguay, Vietnam.
      Submission number: K860149
    • 21 Apr 2026 Z-2216-2026 Class II Ongoing Certain lots of product have the potential for a sterile barrier breach. Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Canada, China, Colombia, Costa…
      Full distribution text Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Canada, China, Colombia, Costa Rica, Cyprus, Denmark, France, Germany, Hong Kong, Hungary, Italy, Japan, Latvia, Lithuania, Malaysia, Moldova, Republic Of, Morocco, Netherlands, Norway, Panama, Poland, Russia, Serbia, Singapore, South Africa, South Korea, Spain, Suriname, Sweden, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, United States, Uruguay, Vietnam.
      Submission numbers: K860149, K953945
    • 21 Apr 2026 Z-2217-2026 Class II Ongoing Certain lots of product have the potential for a sterile barrier breach. Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Canada, China, Colombia, Costa…
      Full distribution text Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Canada, China, Colombia, Costa Rica, Cyprus, Denmark, France, Germany, Hong Kong, Hungary, Italy, Japan, Latvia, Lithuania, Malaysia, Moldova, Republic Of, Morocco, Netherlands, Norway, Panama, Poland, Russia, Serbia, Singapore, South Africa, South Korea, Spain, Suriname, Sweden, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, United States, Uruguay, Vietnam.
      Submission numbers: K860149, K953945
    • 21 Apr 2026 Z-2218-2026 Class II Ongoing Certain lots of product have the potential for a sterile barrier breach. Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Canada, China, Colombia, Costa…
      Full distribution text Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Canada, China, Colombia, Costa Rica, Cyprus, Denmark, France, Germany, Hong Kong, Hungary, Italy, Japan, Latvia, Lithuania, Malaysia, Moldova, Republic Of, Morocco, Netherlands, Norway, Panama, Poland, Russia, Serbia, Singapore, South Africa, South Korea, Spain, Suriname, Sweden, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, United States, Uruguay, Vietnam.
      Submission numbers: K860149, K953945
    • 21 Apr 2026 Z-2219-2026 Class II Ongoing Certain lots of product have the potential for a sterile barrier breach. Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Canada, China, Colombia, Costa…
      Full distribution text Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Canada, China, Colombia, Costa Rica, Cyprus, Denmark, France, Germany, Hong Kong, Hungary, Italy, Japan, Latvia, Lithuania, Malaysia, Moldova, Republic Of, Morocco, Netherlands, Norway, Panama, Poland, Russia, Serbia, Singapore, South Africa, South Korea, Spain, Suriname, Sweden, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, United States, Uruguay, Vietnam.
      Submission numbers: K860149, K953945
    • 21 Apr 2026 Z-2220-2026 Class II Ongoing Certain lots of product have the potential for a sterile barrier breach. Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Canada, China, Colombia, Costa…
      Full distribution text Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Canada, China, Colombia, Costa Rica, Cyprus, Denmark, France, Germany, Hong Kong, Hungary, Italy, Japan, Latvia, Lithuania, Malaysia, Moldova, Republic Of, Morocco, Netherlands, Norway, Panama, Poland, Russia, Serbia, Singapore, South Africa, South Korea, Spain, Suriname, Sweden, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, United States, Uruguay, Vietnam.
      Submission numbers: K860149, K953945
    • 21 Apr 2026 Z-2221-2026 Class II Ongoing Certain lots of product have the potential for a sterile barrier breach. Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Canada, China, Colombia, Costa…
      Full distribution text Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Canada, China, Colombia, Costa Rica, Cyprus, Denmark, France, Germany, Hong Kong, Hungary, Italy, Japan, Latvia, Lithuania, Malaysia, Moldova, Republic Of, Morocco, Netherlands, Norway, Panama, Poland, Russia, Serbia, Singapore, South Africa, South Korea, Spain, Suriname, Sweden, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, United States, Uruguay, Vietnam.
      Submission numbers: K860149, K953945
    • 21 Apr 2026 Z-2222-2026 Class II Ongoing Certain lots of product have the potential for a sterile barrier breach. Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Canada, China, Colombia, Costa…
      Full distribution text Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Canada, China, Colombia, Costa Rica, Cyprus, Denmark, France, Germany, Hong Kong, Hungary, Italy, Japan, Latvia, Lithuania, Malaysia, Moldova, Republic Of, Morocco, Netherlands, Norway, Panama, Poland, Russia, Serbia, Singapore, South Africa, South Korea, Spain, Suriname, Sweden, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, United States, Uruguay, Vietnam.
      Submission numbers: K860149, K953945
    • 13 Jan 2026 Z-1473-2026 Class II Ongoing During the manufacturing, Medtronic personnel identified an assembly issue where the tubing was incorrectly positioned. The short tube was attached to the bottom of the canister, and the long tube was attached to the top, contrary to the intended design. Distribution: US Nationwide. Global Distribution.
Show the 25 most recent of 130 recalls

  • 2025

    • 20 Oct 2025 Z-0539-2026 Class II Ongoing Medtronic personnel observed trace amounts of dry blood on the external carton label and Instructions for Use (IFU) in five boxes of one lot of ACT Cartridges. Distribution: US Nationwide distribution in the states of Hawaii and New York. Submission number: K860122
    • 3 Oct 2025 Z-0509-2026 Class II Ongoing As of August 6, 2025, Medtronic has received eleven reports of VitalFlow Consoles displaying an E70 error code during normal operation. When this occurs, the touch screen may become temporarily unresponsive and go blank for up to two minutes before recovering to full functionality. Importantly, the console continues to maintain set pump speed and function throughout. Distribution: US Nationwide distribution. Submission numbers: K250199, K230364
    • 12 Sep 2025 Z-0487-2026 Class II Ongoing Medtronic identified an Affinity NT Oxygenator unit with decreased CO2 gas transfer rates that did not meet performance requirements. Distribution: US States: AZ, CA, TN Submission number: K241352
    • 6 Aug 2025 Z-2480-2025 Class I Ongoing The catheters may not retain their shape. Distribution: Worldwide - US Nationwide distribution. Submission number: K834039
    • 6 Aug 2025 Z-2481-2025 Class I Ongoing The catheters may not retain their shape. Distribution: Worldwide - US Nationwide distribution. Submission number: K834039
    • 6 Aug 2025 Z-2482-2025 Class I Ongoing The catheters may not retain their shape. Distribution: Worldwide - US Nationwide distribution. Submission number: K834039
    • 5 Feb 2025 Z-1306-2025 Class I Ongoing Unexpected loose material in the male luer used in the aortic root cannula has been identified. Potential harms when identified prior to use - procedure delay. Potential harm if not identified and used - stroke (reversible and irreversible). Distribution: Domestic distribution nationwide. International distribution to the following countries: Albania Algeria Argentina…
      Full distribution text Domestic distribution nationwide. International distribution to the following countries: Albania Algeria Argentina Armenia Australia Austria Azerbaijan Bahrain Bangladesh Belarus Belgium Bosnia And Herzegovina Botswana Brazil Bulgaria Canada Canary Islands Cayman Islands Chile China Colombia Costa Rica Croatia Cyprus Czech Republic Denmark Ecuador Egypt Estonia Finland France Georgia Germany Greece Guatemala Hong Kong Hungary India Indonesia Iran Iraq Ireland Israel Italy Japan Jordan Kazakhstan Kuwait Latvia Lebanon Lithuania Luxembourg Malaysia Moldova, Republic Of Montenegro Morocco Namibia Nepal Netherlands New Zealand North Macedonia NorthernIreland Norway Oman Pakistan Panama Peru Philippines Poland Portugal Puerto Rico Qatar Reunion Romania Russia Saudi Arabia Senegal Serbia Singapore Slovakia Slovenia South Africa South Korea Spain Suriname Sweden Switzerland Taiwan Thailand Turkey Ukraine United Arab Emirates United Kingdom Viet Nam Yemen
      Submission number: K100274

  • 2024

    • 12 Dec 2024 Z-0984-2025 Class II Ongoing Incorrect labeling for seven manufactured lots of certain models of Arterial Cannulae. Distribution: Worldwide - US Nationwide distribution. Submission number: K024069
    • 12 Dec 2024 Z-0985-2025 Class II Ongoing Incorrect labeling for seven manufactured lots of certain models of Arterial Cannulae. Distribution: Worldwide - US Nationwide distribution. Submission number: K031037
    • 12 Dec 2024 Z-0986-2025 Class II Ongoing Incorrect labeling for seven manufactured lots of certain models of Arterial Cannulae. Distribution: Worldwide - US Nationwide distribution. Submission number: K840002
    • 3 Oct 2024 Z-0289-2025 Class II Ongoing There is the potential for a potential sterility breach for three lots of the DLP Aortic Root Cannula due to a misaligned seal Distribution: US: NY, OH, IL, NJ, MI, TN, WI, Australia, and Singapore Submission number: K790565
    • 9 Jul 2024 Z-3128-2024 Class II Ongoing During manufacturing, DLP Single Stage Venous Cannulae - straight tip (Model 66118) was incorrectly placed into a product labeled as DLP Single Stage Venous Cannulae - right angle metal tip (Model 67312). Distribution: Worldwide distribution - US Nationwide and the countries of Cambodia, Greece, Ireland, Italy, Saudi Arabia, Switzerland,…
      Full distribution text Worldwide distribution - US Nationwide and the countries of Cambodia, Greece, Ireland, Italy, Saudi Arabia, Switzerland, United Kingdom, Viet Nam.
      Submission number: K120988
    • 16 May 2024 Z-2423-2024 Class II Ongoing Incorrect component placed in four manufactured lots of the TourniKwik" Tourniquet Set. Distribution: Worldwide - US Nationwide distribution in the states of MN, MA, UT, CA, and FL. The countries of Japan and Slovenia. Submission number: K855144
    • 19 Mar 2024 Z-1793-2024 Class II Ongoing Potential for unsealed sterile packing. Distribution: Worldwide distribution. Submission number: K840002
    • 19 Mar 2024 Z-1794-2024 Class II Ongoing Potential for unsealed sterile packing. Distribution: Worldwide distribution. Submission number: K973485

Frequently asked questions

How many devices does MEDTRONIC PERFUSION SYSTEMS have in the registry?

The registry currently lists 29 devices for MEDTRONIC PERFUSION SYSTEMS. Devices recorded under merged duplicate company entries are counted once.

Which registries list MEDTRONIC PERFUSION SYSTEMS's devices?

Among its 29 most recently registered devices, MEDTRONIC PERFUSION SYSTEMS has devices listed in FDA 510(k) (29 devices).

What risk classes do MEDTRONIC PERFUSION SYSTEMS's devices fall under?

Among its 29 most recently registered devices, the classes recorded for MEDTRONIC PERFUSION SYSTEMS's devices are Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for MEDTRONIC PERFUSION SYSTEMS?

FDA recall records list 130 recalls initiated by MEDTRONIC PERFUSION SYSTEMS, the most recent initiated on 21 Apr 2026. 52 of them are recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What are the newest devices from MEDTRONIC PERFUSION SYSTEMS in the registry?

The most recently registered devices listed for MEDTRONIC PERFUSION SYSTEMS include AFFINITY 20U ARTERIAL FILTER WITH TRILLIUM BIOSURFACE, autoLog IQ Autotransfusion System, EOPA 3D ARTERIAL CANNULA, MODELS 78220, 78222, 78320, 783222 and BIO-CONSOLE 560.

Generated automatically from registry data and not verified by a human reviewer.

This is an FDA establishment record. No EUDAMED registration is known for this company.