Medtronic Implantable Insulin Pump System, REF: MMT-2007D, Sterile EO, CE 0459 UDI: 00763000043001

Recall Insight

This FDA Devices action (record #Z-2206-2020) was formally reported on June 10, 2020, with the manufacturer initiating the action on April 10, 2020. It is classified under Moderate severity (Class II), with a current status of Terminated. Medtronic Inc. is listed as the recalling firm, operating out of Northridge, CA. Federal records indicate 24 Pumps units are affected.

The documented reason for this recall is: Internal testing results showed endotoxin-related test result did not meet specifications for implantable insulin pump. If pumps have higher than allowed endotoxin levels, patients may have an effect of fever, hypotens… Distribution data in the federal record shows the product reached: No US Distribution. OUS: Netherlands, France, and Sweden. 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 6 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.