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Activa PC INS - DBS Extension Kit For Deep Brain Stimulation (2015-04-16)
- Starting date:
- April 16, 2015
- Posting date:
- May 21, 2015
- 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-53403
Recalled Products
A. Activa PC INS - DBS Extension Kit For Deep Brain Stimulation
Reason
Notification to communicate recent results from returned product analysis of Medtronic Neuromodulation Deep Brain Stimulation (DBS) system extensions with reports of high impedances, and reinforces device labeling specific to the handling of extensions and system integrity checking during implant procedures.
Affected products
A. Activa PC INS - DBS Extension Kit For Deep Brain Stimulation
Lot or serial number
All lots.
Model or catalog number
- 37085
- 37086
Companies
- Manufacturer
-
Medtronic Inc.
710 Medtronic Parkway NE
Minneapolis
Minnesota
UNITED STATES