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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Monitoring Devices

Medtronic VitalFlow Consoles Recalled for Touch Screen Display Error

Agency Publication Date: November 14, 2025
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Summary

Medtronic Perfusion Systems is recalling approximately 167 MC3 VitalFlow Consoles (REF 58100) because the touch screen may display an "E70" error code and become unresponsive. During these events, the touch screen may go blank for up to two minutes before recovering. While the screen is blank, the pump continues to maintain its set speed and function normally. Medtronic has received eleven reports of this issue occurring during operation.

Risk

An unresponsive or blank touch screen during medical procedures prevents clinicians from monitoring or adjusting blood pump settings, which can lead to delays in critical clinical decisions. While the console maintains its pump speed during the error, the loss of visibility and control poses a risk to patients undergoing procedures like ECMO.

What You Should Do

  1. This recall affects Medtronic MC3 VitalFlow Consoles (model REF 58100) used for blood pumping during extracorporeal membrane oxygenation (ECMO). Affected units were distributed nationwide in the United States.
  2. Check the model number (REF 58100), the Unique Device Identifier (UDI/DI 10850007732247), and the serial number on the device label to determine if your console is affected. See the Affected Products section below for the full list of affected codes.
  3. Stop using the recalled device immediately to avoid potential display failures during patient procedures.
  4. Contact Medtronic Perfusion Systems or your authorized distributor to arrange for the return, replacement, or correction of the affected console.
  5. Call the FDA Consumer Complaint hotline at 1-888-463-6332 (1-888-INFO-FDA) for additional questions regarding this recall.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: MC3 VitalFlow Console
Model / REF:
58100
Serial Numbers (167):
000023
000047
000073
000100
000126
000150
000173
000197
000223
000024
000048
000075
000101
000127
000151
000174
000202
000224
000025
000051
000076
000102
000128
000152
000177
000203
000225
000027
000052
000078
000103
000129
000153
000179
000204
000228
000028
000054
000079
000104
000130
000154
000180
000205
000229
000029
000055
000080
000106
000131
UDI:
10850007732247

Blood pump used for ECMO procedures.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97806
Status: Active
Manufacturer: Medtronic Perfusion Systems
Sold By: Hospitals; Medical Facilities; Surgical Centers
Manufactured In: United States
Units Affected: 167 units
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.