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Recall Observatory FDA recall evidence

Device product

Cyberonics Vagus Nerve Stimulator (VNS) Therapy AspireSR Generator, Model 106

Z-0280-2016

October 07, 2015

Class II

Product summary

Firm
Cyberonics, Inc
Event
Event 72385
Status
Terminated
Classification
Class II
Quantity
27 units
Official record key
device-enforcement:Z-0280-2016

Official wording

Reason: Certain Model 106 Pulse Generators demonstrate delays in sensing during use of the 'Verify Heartbeat Detection' feature and exhibit potential for decreased battery longevity.

Code information: Serial Numbers: 37719, 37899, 38123, 38414, 38428, 39385, 39531, 39607, 39801, 39821, 40037, 40048, 40249, 40251, 40271, 40354, 40428, 40488, 40526, 40603, 40751, 41000, 41109, 41152, 41805, 42022, 42780

Distribution pattern: US Distribution to the states of : OR, NY, GA, PA, CA, NC, KS, FL, KY, MI, TX, IL, OH, IN, UT, CO and WV.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Certain Model 106 Pulse Generators demonstrate delays in sensing during use of the 'Verify Heartbeat Detection' feature and exhibit potential for decreased battery longevity.