Reported Feb 19, 2020 · Terminated
VNS Therapy SENTIVA Generator Model # 1000 Labeling 26-0009-6800 Model 1000 Generator Sample Labels 26-0009-9600…
LivaNova USA Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: LivaNova USA Inc · 100 Cyberonics Blvd · Houston, TX · 77058-2069
Is this the product you have?
- 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)
- Lot codes and dates
7 of 7 products
Products covered by this recall Model / number Product as published — Model Serial No. UDI 1000204460 01054250257504051119080317201205212044609910-0011-6102 1000183960 01054250257504051119080217200912211839609910-0011-6102 1000194980 01054250257504051119080217201030211949809910-0011-6102 1000204700 01054250257504051119080217201205212047009910-0011-6102 1000206720 01054250257504051119080317201219212067209910-0011-6102 1000213290 01054250257504051119080517210108212132909910-0011-6102 - Amount recalled
- 6 generators
Where it was sold
Why it was recalled
Firm identified a subset of its generators that were sterilized one additional sterilization cycle, which does not meet the firm's quality specifications.
This product could cause temporary or reversible health problems — stop using it.
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