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VNS Therapy Model 105 AspireHC Generator
- Starting date:
- June 26, 2017
- Posting date:
- July 17, 2017
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-64000
Reason
Livanova is notifying customers that certain Model 105 AspireHC and Model 106 AspireSR VNS therapy generators are subject to the potential for reduced battery longevity associated with the manufacturing process used to assemble the circuit board. Physicians of patients with implanted devices are being notified to monitor their impacted patient(s) frequently to check battery status. Only Model 105 devices were imported and distributed in Canada.
Affected products
VNS Therapy Model 105 AspireHC Generator
Lot or serial number
More than 10 numbers, contact manufacturer
Model or catalog number
105
Companies
- Manufacturer
-
Cyberonics Inc.
100 Cyberonics Blvd., Cyberonics Building
Houston
77058
Texas
UNITED STATES