510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
Z-3019-2017Class II

VNS Therapy AspireHC Generator, VNS Therapy AspireSR Generator. Model No. 105

LivaNova USA, Inc. / initiated 2017-06-13 / Terminated / root cause: manufacturing process
FDA source (opens on fda.gov)

Cyberonics, Inc began a recall of VNS Therapy AspireHC Generator, VNS Therapy AspireSR Generator. Model No. 105. Product Usage: United States Indications for Use: Epilepsy (PMA 970003): The VNS... on . FDA classified it as Class II and gives the reason as "Manufacturing process used to assemble the circuit board may result in some devices experiencing a faster than expected reduction in device longevity". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number
Z-3019-2017
Classification
Class II
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
LivaNova USA, Inc.
Product
VNS Therapy AspireHC Generator, VNS Therapy AspireSR Generator. Model No. 105. Product Usage: United States Indications for Use: Epilepsy (PMA 970003): The VNS Therapy System is indicated for use as an adjunctive therapy in reducing the frequency of seizures in adults and adolescents over 12 years of age with partial onset seizures that are refractory to antiepileptic medications. Depression (PMA 970003/S050): VNS Therapy is indicated for the adjunctive long-term treatment of chronic or recurrent depression for patients 18 years of age or older who are experiencing a major depressive episode and have not had an adequate response to four or more adequate antidepressant treatments. Indications outside the U.S.: Epilepsy (Non-US): The VNS Therapy System is indicated for use as an adjunctive therapy in reducing the frequency of seizures in patients whose epileptic disorder is dominated by partial seizure (with or without secondary generalization) or generalized seizures that are refractory to antiepileptic medications. AspireSR (Seizure Response) features the Automatic Stimulation Mode which is intended for patients who experience seizures that are associated with cardiac rhythm increases known as ictal tachycardia. Depression (Non-US): The VNS Therapy System is indicated for the treatment of chronic or recurrent depression in patients who are experiencing a treatment-resistant or treatment-intolerant depressive episode.
Product code
LYJ Stimulator, Autonomic Nerve, Implanted For Epilepsy
Reason for recall
Manufacturing process used to assemble the circuit board may result in some devices experiencing a faster than expected reduction in device longevity.
Root cause tag
manufacturing process
FDA root cause
Manufacturing material removal
Action
Affected hospitals were notified beginning on 06/13/2017 and prescribing physicians were notified beginning on 06/28/2017. Instructions for affected hospitals included examine inventory, quarantine any affected devices, return the devices, complete and return the response form. Instructions for prescribing physicians included to monitory patients frequently and perform diagnostic testing at each visit, ensure patients are using the device regularly to verify stimulation is felt, ensure patients notify their physician if stimulation changes, and complete and return the response form.
Quantity in commerce
396 units
Distribution
Worldwide Distribution - US Nationwide and Puerto Rico and the following states: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY, Puerto Rico. Distribution internationally to Argentina, Austria, Belgium, Canada, Croatia, Czech Republic, Finland, Germany, Ireland, Israel, Italy, Japan, Lebanon, Netherlands, Norway, Poland, Qatar, Saudi Arabia, United Arab Emirates, and United Kingdom.
Product codes and lots
Serial No. (Exp Date): 35283 (01/22/2017), 35339 (01/22/2017), 35354 (01/22/2017), 35355 (01/22/2017), 35458 (01/22/2017), 35474 (01/22/2017), 35487 (01/22/2017), 35492 (01/22/2017), 35561 (01/22/2017), 35565 (01/22/2017), 35568 (01/22/2017), 35603 (01/22/2017), 35614 (02/05/2017), 35615 (02/05/2017), 35617 (02/05/2017), 35618 (02/05/2017), 35624 (02/05/2017), 35625 (02/05/2017), 35634 (02/05/2017), 35705 (02/05/2017), 35706 (02/05/2017), 35767 (02/05/2017), 35771 (02/05/2017), 35774 (02/05/2017), 35795 (02/05/2017), 35797 (02/05/2017), 35801 (02/05/2017), 35807 (02/05/2017), 35826 (02/05/2017), 35856 (02/05/2017), 35857 (02/05/2017), 35862 (02/05/2017), 35864 (02/05/2017), 35887 (02/05/2017), 35888 (02/05/2017), 35890 (02/05/2017), 35891 (02/05/2017), 35900 (02/05/2017), 35904 (02/05/2017), 35905 (02/05/2017), 35906 (02/05/2017), 35908 (02/05/2017), 35909 (02/05/2017), 35910 (02/05/2017), 35911 (02/05/2017), 35913 (02/05/2017), 35914 (02/05/2017), 35915 (02/05/2017), 35926 (02/05/2017), 36060 (05/01/2017), 36067 (02/05/2017), 36068 (02/05/2017), 36073 (02/05/2017), 36082 (02/05/2017), 36084 (02/05/2017), 36085 (02/05/2017), 36090 (02/05/2017), 36132 (02/05/2017), 36140 (02/05/2017), 36141 (02/05/2017), 36143 (02/05/2017), 36151 (02/05/2017), 36983 (05/01/2017), 37596 (04/23/2017), 37873 (04/02/2017), 37882 (04/02/2017), 37883 (04/02/2017), 37917 (04/02/2017), 37929 (04/02/2017), 37973 (04/02/2017), 37978 (04/02/2017), 37979 (04/02/2017), 37980 (04/02/2017), 37982 (04/02/2017), 37983 (04/02/2017), 37986 (04/02/2017), 37991 (04/02/2017), 38048 (04/02/2017), 38052 (04/02/2017), 38061 (04/02/2017), 38102 (04/02/2017), 38130 (04/02/2017), 38139 (04/02/2017), (04/02/2017), 38141 (04/02/2017), 38150 (04/02/2017), 38156 (04/02/2017),  38160 (04/02/2017), 38187 (04/02/2017), 38220 (04/02/2017), 38227 (04/02/2017), 38232 (04/02/2017), 38242 (04/02/2017), 38247 (04/02/2017), 38250 (04/02/2017), 38257 (04/02/2017), 38262 (04/02/2017), 38267 (04/02/2017), 38269 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38634 (04/23/2017), 38636 (04/23/2017), 38649 (04/23/2017), 38653 (04/23/2017), 38654 (04/23/2017), 38656 (04/23/2017), 38658 (04/23/2017), 38659 (04/23/2017), 38660 (04/23/2017), 38663 (04/23/2017), 38666 (04/23/2017), 38673 (04/23/2017), 38677 (04/23/2017), 38678 (04/23/2017), 38680 (04/23/2017), 38681 (04/23/2017), 38682 (04/23/2017), 38683 (04/23/2017), 38684 (04/23/2017), 38686 (04/23/2017), 38690 (04/23/2017), 38694 (04/23/2017), 38695 (04/02/2017),  38696 (04/23/2017), 38697 (04/02/2017), 38699 (04/02/2017), 38701 (04/02/2017), 38704 (04/02/2017), 38705 (04/02/2017), 38706 (04/02/2017), 38707 (04/02/2017), 38708 (04/02/2017), 38709 (04/02/2017), 38710 (04/02/2017), 38711 (04/02/2017), 38715 (04/02/2017), 38721 (04/23/2017), 38723 (04/23/2017), (04/23/2017), 38724 (04/23/2017), 38726 (04/23/2017), 38727 (04/23/2017), 38728 (04/23/2017), 38729 (04/23/2017), 38731 (04/23/2017), 38733 (04/02/2017), 38734 (04/23/2017), 38736 (04/23/2017), 38737 (04/23/2017), 38738 (04/02/2017), 38739 (04/02/2017), 38740 (04/02/2017), 38741 (04/02/2017), 38743 (04/02/2017), 38748 (04/23/2017), 38749 (04/23/2017), 38750 (04/23/2017), 38757 (04/23/2017), 38763 (04/02/2017), 38764 (04/02/2017), 38765 (04/02/2017), 38767 (04/02/2017), 38776 (04/02/2017), 38778 (04/02/2017), 38780 (04/02/2017), 38781 (04/02/2017), 38788 (04/02/2017), 38790 (04/02/2017), 38796 (04/02/2017), 38798 (04/02/2017), 38799 (04/02/2017), 38806 (04/02/2017), 38807 (04/02/2017), 38810 (04/02/2017), 38835 (05/01/2017), 38841 (05/01/2017), 38844 (05/01/2017), 38847 (05/01/2017), 38848 (05/01/2017), 38856 (05/01/2017), 38858 (05/01/2017), 38859 (05/01/2017), 38862 (05/01/2017), 38863 (05/01/2017), 38864 (05/01/2017), 38867 (05/01/2017), 38868 (05/01/2017), 38869 (05/01/2017), 38877 (05/01/2017), 38880 (05/01/2017), 38881 (05/01/2017), 38882 (05/01/2017), 38883 (05/01/2017), 38884 (05/01/2017), 38886 (05/01/2017), 38887 (05/01/2017), 38888 (05/01/2017), 38891 (05/01/2017), 38892 (05/01/2017), 38894 (05/01/2017), 38896 (05/01/2017), 38897 (05/01/2017), 38901 (05/01/2017), 38902 (05/01/2017), 38904 (05/01/2017), 38905 (05/01/2017), 38909 (05/01/2017), 38912 (05/01/2017), 38915 (05/01/2017), 38918 (05/01/2017), 38920 (05/01/2017), 38924 (05/01/2017), 38925 (05/01/2017), 38928 (05/01/2017), 38930 (05/01/2017), 38931 (05/01/2017), 38934 (05/01/2017), 38936 (05/01/2017), 38941 (05/01/2017), 38942 (05/01/2017), 38943 (05/01/2017), 38944 (05/01/2017), 38946 (05/01/2017), 38947 (05/01/2017), 38948 (05/01/2017), 38954 (05/01/2017), 38957 (05/01/2017), 38958 (05/01/2017), 38959 (05/01/2017), 38961 (05/01/2017), 38965 (05/01/2017), 38966 (05/01/2017), 38968 (05/01/2017), 38970 (05/01/2017), 38971 (05/01/2017), 38973 (05/01/2017), 38974 (05/01/2017), 38976 (05/01/2017), 38982 (05/01/2017), 38983 (05/01/2017), 38984 (05/01/2017), 38989 (05/01/2017), 38994 (05/01/2017), 38999 (05/01/2017), 39000 (05/01/2017), 39003 (05/01/2017), 39004 (05/01/2017), 39008 (05/01/2017), 39009 (05/01/2017), 39010 (05/01/2017), 39014 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(05/01/2017), 39734 (05/01/2017)

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-3019-2017
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-3019-2017Class IITerminatedVoluntary: Firm initiated
Z-3020-2017Class IITerminatedVoluntary: Firm initiated