VNS Therapy SENTIVA Generator Model # 1000 Labeling 26-0009-6800 Model 1000 Generator Sample Labels 26-0009-9600 Patient s Manual for Depression 26-0009-9500 Patient s Manual for Epilepsy 76-0000-5000 VNS Therapy System Physician s Manual (refer to Attachment 1)

Recall Insight

This FDA Devices action (record #Z-1118-2020) was formally reported on February 19, 2020, with the manufacturer initiating the action on August 13, 2019. It is classified under Moderate severity (Class II), with a current status of Terminated. LivaNova USA Inc is listed as the recalling firm, operating out of Houston, TX. Federal records indicate 6 generators units are affected.

The documented reason for this recall is: Firm identified a subset of its generators that were sterilized one additional sterilization cycle, which does not meet the firm's quality specifications. Distribution data in the federal record shows the product reached: US: FL, GA, KS, MO, and UT. No OUS distribution. 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.