Recall Z-1118-2020
LivaNova USA Inc · initiated August 13, 2019
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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)
Codes / lots: Model Serial No. UDI Model 1000 204460 01054250257504051119080317201205212044609910-0011-6102 Model 1000 183960 01054250257504051119080217200912211839609910-0011-6102 Model 1000 194980 01054250257504051119080217201030211949809910-0011-6102 Model 1000 204700 01054250257504051119080217201205212047009910-0011-6102 Model 1000 206720 01054250257504051119080317201219212067209910-0011-6102 Model 1000 213290 01054250257504051119080517210108212132909910-0011-6102
Reason for recall
Firm identified a subset of its generators that were sterilized one additional sterilization cycle, which does not meet the firm's quality specifications.
FDA-determined cause: Process control
Action taken
On 08/13/2019, the firm contacted via telephone hospitals/facilities of the immediate need to remove and replace the affected devices. Reference Firm email communication dated 1/27/2020. On 08/30/2019, prescribing physicians were telephone call with a follow-up email recommending replacement of the generators during an already planned or unrelated lead replacement surgery.
Details
- Recall number
- Z-1118-2020
- Initiated
- August 13, 2019
- Terminated
- May 18, 2022
- Product code
- LYJ – Stimulator, Autonomic Nerve, Implanted For Epilepsy
- Quantity
- 6 generators
- Distribution
- US: FL, GA, KS, MO, and UT. No OUS distribution
- Recalling firm
- LivaNova USA Inc, Houston, TX