Medtronic's EnTrust Dual Chamber (2018-06-21)
- Starting date:
- June 21, 2018
- Posting date:
- July 5, 2018
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type I
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-67184
Affected products
A. ENTRUST DUAL CHMBR. IMPL. DEFIB. - W/ARTER. & VENTRIC. THER. & RAPID TELEM.
B. ENTRUST DUAL CHMBR. CARDIOVERTER DEFIB. W/ATRIA & VENT. THER. & RAPID TELEM
C. ENTRUST DUAL CHMBR. IMPL. CARDIO. DEFI. W/VENTR. THER. & RAPIDR. TELEM.
Reason
There is a potential for loss of high voltage and anti-tachycardia pacing therapy in entrust Implantable Cardioverter Defibrillators (ICDS) as they near Elective Replacement Indicator (ERI) voltage. Under certain circumstances, the device may display an immediate End Of Life (EOL) observation with no prior ERI alert. Though no ERI alert is triggered there may not be enough remaining battery capacity to charge the high voltage circuits, resulting in an excessive charge time EOL observation, leading to a loss of high voltage and anti-tachycardia pacing therapy. Bradycardia therapies will continue to operate as expected.
Affected products
A. ENTRUST DUAL CHMBR. IMPL. DEFIB. - W/ARTER. & VENTRIC. THER. & RAPID TELEM.
Lot or serial number
All lots.
Model or catalog number
D154ATG
Companies
- Manufacturer
-
Medtronic Inc.
710 Medtronic Parkway
Minneapolis
55432
Minnesota
UNITED STATES
B. ENTRUST DUAL CHMBR. CARDIOVERTER DEFIB. W/ATRIA & VENT. THER. & RAPID TELEM
Lot or serial number
All lots.
Model or catalog number
D153ATG
Companies
- Manufacturer
-
Medtronic Inc.
710 Medtronic Parkway
Minneapolis
55432
Minnesota
UNITED STATES
C. ENTRUST DUAL CHMBR. IMPL. CARDIO. DEFI. W/VENTR. THER. & RAPIDR. TELEM.
Lot or serial number
All lots.
Model or catalog number
D154VRC
Companies
- Manufacturer
-
Medtronic Inc.
710 Medtronic Parkway
Minneapolis
55432
Minnesota
UNITED STATES