Medtronic Invos, Reusable Infant Sensor Adapter Cable for PM7100, REF: PMAC71RIC

Recall Insight

This FDA Devices action (record #Z-1731-2024) was formally reported on May 8, 2024, with the manufacturer initiating the action on January 9, 2024. It is classified under Moderate severity (Class II), with a current status of Ongoing. Covidien is listed as the recalling firm, operating out of Boulder, CO. Federal records indicate 1122 units units are affected.

The documented reason for this recall is: manufacturing defects to sensor cable connectors may result in error codes or non-functioning channel Distribution data in the federal record shows the product reached: US: AK AZ CA CT FL GA IA IN LA MA MD MI MN MO NC NY OH OK PA SC TN TX VA WA WI OUS: Australia Austria Belgium Canary Islands Chile Czech Republic Denmark Finland France Germany Guatemala Indonesia Ireland Italy Japan Ko…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 2 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.