Implantable Cardioverter Defibrillator (2021-02-03)
- Starting date:
- February 3, 2021
- Posting date:
- February 19, 2021
- 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-75013
Last updated: 2021-02-22
Affected Products
- VIVA XT CRT-D DIGITAL IMPLANTABLE CARDIOVERTER DEFIBRILLATOR WITH CARDIAC RESYNCHRONIZATION THERAPY
- VIVA S CRT-D DIGITAL IMPLANTABLE CARDIOVERTER DEFIBRILLATOR WITH CARDIAC RESYNCHRONIZATION THERAPY
- BRAVA CRT-D DIGITAL IMPLANTABLE CARDIOVERTER DEFIBRILLATOR WITH CARDIAC RESYNCHRONIZATION THERAPY
- VIVA QUAD XT CRT-D
- EVERA XT DR DIGITAL DUAL CHAMBER IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
- EVERA S DR DIGITAL DUAL CHAMBER IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
- EVERA XT VR DIGITAL SINGLE CHAMBER IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
- EVERA S VR DIGITAL SINGLE CHAMBER IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
- BRAVA QUAD CRT-D
- VIVA QUAD S CRT-D
- EVERA MRI XT DR SURESCAN
- EVERA MRI XT VR SURESCAN
- EVERA MRI S DR SURESCAN
- EVERA MRI S VR SURESCAN
- VISIA AF S VR
- VISIA AF MRI XT VR SURESCAN
- VISIA AF MRI S VR SURESCAN
- AMPLIA MRI QUAD CRT-D SURESCAN
Reason
Notification informing customers of a potential issue for a subset of Implantable Cardioverter Defibrillators (ICDs) and Cardiac Esynchronization Therapy Defibrillators (CRT-DS). Medtronic has identified that a small percentage of implanted cardiac devices, from a well-defined subset, may experience a shortened Recommended Replacement Time (RRT) to End of Service (EOS) interval following an earlier-than-expected RRT observation. The subset of ICDs and CRT-DS affected by this issue were last implanted in February 2019 and manufactured with a specific battery design that is no longer being distributed.
The rapid depletion is caused by a latent shorting mechanism involving lithium plating, resulting from a thermal gradient between the anode and cathode components of the battery. Devices with higher pacing outputs and high pacing percentages (e.g. CRT-D devices) have the lowest probability of occurrence. Conversely, devices with low current drain (evidenced by a longer overall service time from implant to RRT) have a higher probability of experiencing this issue. The probability of this issue developing is constant after approximately three years of service time.
Affected products
A. VIVA XT CRT-D DIGITAL IMPLANTABLE CARDIOVERTER DEFIBRILLATOR WITH CARDIAC RESYNCHRONIZATION THERAPY
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
- DTBA2D1
- DTBA2D4
Companies
- Manufacturer
-
Medtronic Inc.
710 Medtronic Parkway
Minneapolis
55432
Minnesota
UNITED STATES
B. VIVA S CRT-D DIGITAL IMPLANTABLE CARDIOVERTER DEFIBRILLATOR WITH CARDIAC RESYNCHRONIZATION THERAPY
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
- DTBB2D1
- DTBB2D4
Companies
- Manufacturer
-
Medtronic Inc.
710 Medtronic Parkway
Minneapolis
55432
Minnesota
UNITED STATES
C. BRAVA CRT-D DIGITAL IMPLANTABLE CARDIOVERTER DEFIBRILLATOR WITH CARDIAC RESYNCHRONIZATION THERAPY
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
- DTBC2D1
- DTBC2D4
Companies
- Manufacturer
-
Medtronic Inc.
710 Medtronic Parkway
Minneapolis
55432
Minnesota
UNITED STATES
D. VIVA QUAD XT CRT-D
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
- DTBA2Q1
- DTBA2QQ
Companies
- Manufacturer
-
Medtronic Inc.
710 Medtronic Parkway
Minneapolis
55432
Minnesota
UNITED STATES
E. EVERA XT DR DIGITAL DUAL CHAMBER IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
- DDBB2D1
- DDBB2D4
Companies
- Manufacturer
-
Medtronic Inc.
710 Medtronic Parkway
Minneapolis
55432
Minnesota
UNITED STATES
F. EVERA S DR DIGITAL DUAL CHAMBER IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
- DDBC3D1
- DDBC3D4
Companies
- Manufacturer
-
Medtronic Inc.
710 Medtronic Parkway
Minneapolis
55432
Minnesota
UNITED STATES
G. EVERA XT VR DIGITAL SINGLE CHAMBER IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
- DVBB2D1
- DVBB2D4
Companies
- Manufacturer
-
Medtronic Inc.
710 Medtronic Parkway
Minneapolis
55432
Minnesota
UNITED STATES
H. EVERA S VR DIGITAL SINGLE CHAMBER IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
- DVBC3D1
- DVBC3D4
Companies
- Manufacturer
-
Medtronic Inc.
710 Medtronic Parkway
Minneapolis
55432
Minnesota
UNITED STATES
I. BRAVA QUAD CRT-D
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
- DTBC2Q1
Companies
- Manufacturer
-
Medtronic Inc.
710 Medtronic Parkway
Minneapolis
55432
Minnesota
UNITED STATES
J. VIVA QUAD S CRT-D
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
- DTBB2QQ
Companies
- Manufacturer
-
Medtronic Inc.
710 Medtronic Parkway
Minneapolis
55432
Minnesota
UNITED STATES
K. EVERA MRI XT DR SURESCAN
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
- DDMB2D1
- DDMB2D4
Companies
- Manufacturer
-
Medtronic Inc.
710 Medtronic Parkway
Minneapolis
55432
Minnesota
UNITED STATES
L. EVERA MRI XT VR SURESCAN
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
- DVMB2D1
- DVMB2D4
Companies
- Manufacturer
-
Medtronic Inc.
710 Medtronic Parkway
Minneapolis
55432
Minnesota
UNITED STATES
M. EVERA MRI S DR SURESCAN
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
- DDMC3D1
- DDMC3D4
Companies
- Manufacturer
-
Medtronic Inc.
710 Medtronic Parkway
Minneapolis
55432
Minnesota
UNITED STATES
N. EVERA MRI S VR SURESCAN
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
- DVMC3D1
- DVMC3D4
Companies
- Manufacturer
-
Medtronic Inc.
710 Medtronic Parkway
Minneapolis
55432
Minnesota
UNITED STATES
O. VISIA AF S VR
Lot or serial number
- BWU600507S
- BWU600508S
- BWU600509S
- BWU600619S
- BWU600622S
- BWU600625S
- BWU600627S
- BWU600631S
- BWV600014S
- BWV600015S
Model or catalog number
- DVAC3D1
- DVAC3D4
Companies
- Manufacturer
-
Medtronic Inc.
710 Medtronic Parkway
Minneapolis
55432
Minnesota
UNITED STATES
P. VISIA AF MRI XT VR SURESCAN
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
- DVFB2D4
Companies
- Manufacturer
-
Medtronic Inc.
710 Medtronic Parkway
Minneapolis
55432
Minnesota
UNITED STATES
Q. VISIA AF MRI S VR SURESCAN
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
- DVFC3D4
Companies
- Manufacturer
-
Medtronic Inc.
710 Medtronic Parkway
Minneapolis
55432
Minnesota
UNITED STATES
R. AMPLIA MRI QUAD CRT-D SURESCAN
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
- DTMB2QQ
Companies
- Manufacturer
-
Medtronic Inc.
710 Medtronic Parkway
Minneapolis
55432
Minnesota
UNITED STATES