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Itrel 3 System and Enterra Therapy Implantable Pulse Generator (IPG), and InterStim system - InterStim Implantable Stimulator (2015-01-08)
- Starting date:
- January 8, 2015
- Posting date:
- January 21, 2015
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-43399
Recalled Products
A) Itrel 3 System Implantable Pulse Generator
B) InterStim system - InterStim Implantable Stimulator
C) Enterra Therapy Implantable Pulse Generator (IPG)
Reason
This notification is to inform regarding an update to the labeling related to the cycling feature in some neuro stimulation devices used for sacral nerve stimulation, gastric electrical stimulation and spinal cord stimulation. The current labeling indicates that the use of cycling improves device longevity under every programming scenario.
Affected products
A) Itrel 3 System Implantable Pulse Generator
Lot or serial number
All lots.
Model or catalog number
7425
Companies
- Manufacturer
-
Medtronic Inc.
710 Medtronic Parkway NE
Minneapolis
55432
Minnesota
UNITED STATES
B) InterStim system - InterStim Implantable Stimulator
Lot or serial number
All lots.
Model or catalog number
3023
Companies
- Manufacturer
-
Medtronic Inc.
710 Medtronic Parkway NE
Minneapolis
55432
Minnesota
UNITED STATES
C) Enterra Therapy Implantable Pulse Generator (IPG)
Lot or serial number
All lots.
Model or catalog number
3116
Companies
- Manufacturer
-
Medtronic Inc.
710 Medtronic Parkway NE
Minneapolis
55432
Minnesota
UNITED STATES