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Medtronic Restore and PrimeAdvanced Neurostimulators (2014-02-18)
- Starting date:
- February 18, 2014
- Posting date:
- March 25, 2014
- 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-38573
Recalled Products
A. Restore Multi-Program Rechargeable Neurostimulator - Main Unit
B. Restore Multi-Program Neurostimulator - External Neurostimulator
C. PrimeAdvanced Multi-Program Neurostimulator - Main Unit
D. RestoreAdvanced Multi-Program Neurostimulator - Main Unit
E. RestoreUltra Multi-Program Neurostimulator System - Main Unit
F. RestoreUltra Multi-Program Neurostimulator Syst - External Neurostimulator
G. Activa PC INS - Multi-Program Neurostimulator
H. Activa RC Multi-Program Rechargeable Neurostimulator
I. RestoreSensor Multi-Program Rechargeable Neurostimulator
J. Activa SC - Neurostimulator
K. Itrel 4 System - Implantable Neurostimulator (INS)
L. RestoreUltra Surescan MRI Neurostimulator
M. RestoreAdvanced Surescan MRI Neurostimulator
N. RestoreSensor Surescan MRI Neurostimulator
O. PrimeAdvanced Surescan MRI Neurostimulator
Reason
Notification regarding corrections to labeling related to the cycling feature in some neurostimulation devices used for deep brain stimulation and spinal cord stimulation (SCS) therapy. Current labeling indicates the use of cycling improves device longevity and recharge interval under all programming scenarios
Affected products
A. Restore Multi-Program Rechargeable Neurostimulator - Main Unit
Lot or serial number
37711
Model or catalog number
All lots
Companies
- Manufacturer
-
Medtronic Inc.
710 Medtronic Parkway NE
Minneapolis
55432
Minnesota
UNITED STATES
B. Restore Multi-Program Neurostimulator - External Neurostimulator
Lot or serial number
37021
Model or catalog number
All lots
Companies
- Manufacturer
-
Medtronic Inc.
710 Medtronic Parkway NE
Minneapolis
55432
Minnesota
UNITED STATES
C. PrimeAdvanced Multi-Program Neurostimulator - Main Unit
Lot or serial number
37702
Model or catalog number
All lots
Companies
- Manufacturer
-
Medtronic Inc.
710 Medtronic Parkway NE
Minneapolis
55432
Minnesota
UNITED STATES
D. RestoreAdvanced Multi-Program Neurostimulator - Main Unit
Lot or serial number
37713
Model or catalog number
All lots
Companies
- Manufacturer
-
Medtronic Inc.
710 Medtronic Parkway NE
Minneapolis
55432
Minnesota
UNITED STATES
E. RestoreUltra Multi-Program Neurostimulator System - Main Unit
Lot or serial number
37712
Model or catalog number
All lots
Companies
- Manufacturer
-
Medtronic Inc.
710 Medtronic Parkway NE
Minneapolis
55432
Minnesota
UNITED STATES
F. RestoreUltra Multi-Program Neurostimulator Syst - External Neurostimulator
Lot or serial number
37022
Model or catalog number
All lots
Companies
- Manufacturer
-
Medtronic Inc.
710 Medtronic Parkway NE
Minneapolis
55432
Minnesota
UNITED STATES
G. Activa PC INS - Multi-Program Neurostimulator
Lot or serial number
37601
Model or catalog number
All lots
Companies
- Manufacturer
-
Medtronic Inc.
710 Medtronic Parkway NE
Minneapolis
55432
Minnesota
UNITED STATES
H. Activa RC Multi-Program Rechargeable Neurostimulator
Lot or serial number
37612
Model or catalog number
All lots
Companies
- Manufacturer
-
Medtronic Inc.
710 Medtronic Parkway NE
Minneapolis
55432
Minnesota
UNITED STATES
I. RestoreSensor Multi-Program Rechargeable Neurostimulator
Lot or serial number
37714
Model or catalog number
All lots
Companies
- Manufacturer
-
Medtronic Inc.
710 Medtronic Parkway NE
Minneapolis
55432
Minnesota
UNITED STATES
J. Activa SC - Neurostimulator
Lot or serial number
37602
37603
Model or catalog number
All lots
Companies
- Manufacturer
-
Medtronic Inc.
710 Medtronic Parkway NE
Minneapolis
55432
Minnesota
UNITED STATES
K. ITREL 4 System - Implantable Neurostimulator (INS)
Lot or serial number
37703
37704
Model or catalog number
All lots
Companies
- Manufacturer
-
Medtronic Inc.
710 Medtronic Parkway NE
Minneapolis
55432
Minnesota
UNITED STATES
L. RestoreUltra Surescan MRI Neurostimulator
Lot or serial number
97712
Model or catalog number
All lots
Companies
- Manufacturer
-
Medtronic Inc.
710 Medtronic Parkway NE
Minneapolis
55432
Minnesota
UNITED STATES
M. RestoreAdvanced Surescan MRI Neurostimulator
Lot or serial number
97713
Model or catalog number
All lots
Companies
- Manufacturer
-
Medtronic Inc.
710 Medtronic Parkway NE
Minneapolis
55432
Minnesota
UNITED STATES
N. RestoreSensor Surescan MRI Neurostimulator
Lot or serial number
97714
Model or catalog number
All lots
Companies
- Manufacturer
-
Medtronic Inc.
710 Medtronic Parkway NE
Minneapolis
55432
Minnesota
UNITED STATES
O. PrimeAdvanced Surescan MRI Neurostimulator
Lot or serial number
97702
Model or catalog number
All lots
Companies
- Manufacturer
-
Medtronic Inc.
710 Medtronic Parkway NE
Minneapolis
55432
Minnesota
UNITED STATES