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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

Covidien: Invos Sensor Cables Recalled for Connector Defects and System Errors

Agency Publication Date: April 30, 2024
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Summary

Covidien is recalling 3,427 Medtronic Invos reusable sensor and adapter cables used with the PM7100 monitoring system. Manufacturing defects in the sensor cable connectors can cause the device to display error codes or lead to a non-functioning monitoring channel. This issue affects specific lots of both the Reusable Infant Sensor Adapter Cable and the Reusable Sensor Cable manufactured in the United States. Consumers should contact their healthcare provider or the manufacturer to determine if their specific units are affected and for next steps regarding replacements.

Risk

The defective connectors can cause the monitoring system to stop working or fail to provide accurate data. In a clinical setting, a non-functioning channel or system error could prevent healthcare providers from properly monitoring a patient's oxygen levels or other vital metrics, potentially delaying critical medical interventions.

What You Should Do

  1. Identify if you have the Medtronic Invos Reusable Infant Sensor Adapter Cable (REF: PMAC71RIC) by checking for Lot numbers 20221220 or 20230721 and UDI 10884521806436.
  2. Identify if you have the Medtronic Invos Reusable Sensor Cable (REF: PMAC71RSC) by checking for Lot numbers 2023-02-22, 2023-04-28, 2023-05-04, or 2023-07-20 and UDI 10884521780125.
  3. If you identify an affected cable, contact your healthcare provider or Covidien/Medtronic immediately to discuss how to obtain a functioning replacement.
  4. Report any technical issues or errors encountered while using these cables to Medtronic's technical support.
  5. For further information or questions regarding this recall, contact the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Manufacturer consultation and replacement

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: Medtronic Invos, Reusable Infant Sensor Adapter Cable for PM7100
Model / REF:
REF: PMAC71RIC
UDI: 10884521806436
Lot Numbers:
20221220
20230721
Product: Medtronic Invos, Reusable Sensor Cable for PM7100
Model / REF:
REF: PMAC71RSC
UDI: 10884521780125
Lot Numbers:
2023-02-22
2023-04-28
2023-05-04
2023-07-20

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93883
Status: Active
Manufacturer: Covidien
Sold By: Medical distributors; Covidien direct sales
Manufactured In: United States
Units Affected: 2 products (1122 units; 2305 units)
Distributed To: Alaska, Arizona, California, Connecticut, Florida, Georgia, Iowa, Indiana, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington, Wisconsin

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.