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Health product recall

Medtronic Inc. Neurostimulators (2016-05-16)

Starting date:
May 16, 2016
Posting date:
June 13, 2016
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-58828

Affected products

  1. KINETRA NEUROSTIMULATOR PULSE GENERATOR & ACCESSORY KIT
  2. ACTIVA PC INS - MULTI-PROGRAM NEUROSTIMULATOR
  3. ACTIVA PC INS - DBS EXTENSION KIT FOR DEEP BRAIN STIMULATION
  4. ACTIVA RC MULTI-PROGRAM RECHARGEABLE NEUROSTIMULATOR
  5. ACTIVA RC NEUROSTIMULATOR - DBS EXTENSION KIT FOR DEEP BRAIN STIMULATION
  6. LOW PROFILE NEUROSTIMULATOR EXTENSION
  7. SOLETRA QUADRIPOLAR MULTI-PROGRAMMABLE NEUROSTIMULATOR
  8. ACTIVA SC - NEUROSTIMULATOR

Affected products

A. KINETRA NEUROSTIMULATOR PULSE GENERATOR & ACCESSORY KIT

Lot or serial number

All lots

Model or catalog number
  • 7428
Companies
Manufacturer
Medtronic Inc.
710 Medtronic Parkway NE
Minneapolis
55432
Minnesota
UNITED STATES

B. ACTIVA PC INS - MULTI-PROGRAM NEUROSTIMULATOR

Lot or serial number

All lots

Model or catalog number
  • 37601
Companies
Manufacturer
Medtronic Inc.
710 Medtronic Parkway NE
Minneapolis
55432
Minnesota
UNITED STATES

C. ACTIVA PC INS - DBS EXTENSION KIT FOR DEEP BRAIN STIMULATION

Lot or serial number

All lots

Model or catalog number
  • 37086
Companies
Manufacturer
Medtronic Inc.
710 Medtronic Parkway NE
Minneapolis
55432
Minnesota
UNITED STATES

D. ACTIVA RC MULTI-PROGRAM RECHARGEABLE NEUROSTIMULATOR

Lot or serial number

All lots

Model or catalog number
  • 37612
Companies
Manufacturer
Medtronic Inc.
710 Medtronic Parkway NE
Minneapolis
55432
Minnesota
UNITED STATES

E.  ACTIVA RC NEUROSTIMULATOR - DBS EXTENSION KIT FOR DEEP BRAIN STIMULATION

Lot or serial number

All lots

Model or catalog number
  • 37086
Companies
Manufacturer
Medtronic Inc.
710 Medtronic Parkway NE
Minneapolis
55432
Minnesota
UNITED STATES

F.  LOW PROFILE NEUROSTIMULATOR EXTENSION

Lot or serial number

All lots

Model or catalog number
  • 7483
Companies
Manufacturer
Medtronic Inc.
710 Medtronic Parkway NE
Minneapolis
55432
Minnesota
UNITED STATES

G. SOLETRA QUADRIPOLAR MULTI-PROGRAMMABLE NEUROSTIMULATOR

Lot or serial number

All lots

Model or catalog number
  • 7426
Companies
Manufacturer
Medtronic Inc.
710 Medtronic Parkway NE
Minneapolis
55432
Minnesota
UNITED STATES

H. ACTIVA SC - NEUROSTIMULATOR

Lot or serial number

All lots

Model or catalog number
  • 37602
  • 37603
Companies
Manufacturer
Medtronic Inc.
710 Medtronic Parkway NE
Minneapolis
55432
Minnesota
UNITED STATES