Health product recall

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