Health product recall

Unify and Unify Assura, Fortify VR, DR, ST VR, ST DR, Assura VR, Assura DR Quadra Assura, Assura MP, and Unify Quadra Cardiac Resynchronization Device, Tiered-therapy Cardioverter/Defibrillator (2018-06-01)

Starting date:
June 1, 2018
Posting date:
June 22, 2018
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-67076

Affected products

A. Unify
B. Fortify VR
C. Fortify DR
D. Fortify ST VR
E. Fortify ST DR
F. Unify Quadra Cardiac Resynchronization Device, Tiered-therapy Cardioverter/Defibrillator
G. Fortify Assura DR
H. Fortify Assura VR
I. Unify Assura
J. Quadra Assura
K. Quadra Assura MP

Reason

As part of a planned series of updates that began in 2017, Abbott is providing customers with upgraded firmware intended to improve the performance of our high voltage implantable cardiac devices (ICDs and CRT-Ds). The firmware upgrade is recommended for all eligible patients and includes a Battery Performance Alert (BPA) update to provide further detection capability for premature battery depletion in devices subject to the October 10, 2016 Medical Device Advisory ("battery advisory devices").

This firmware upgrade has now received regulatory approval from Health Canada.

This firmware upgrade incorporates the BPA for device-based detection of abnormal battery performance due to lithium cluster induced shorts in our Fortify, Fortify Assura, Quadra Assura, Quadra Assura MP, Unify, Unify Assura, and Unify Quadra for devices manufactured between January 2010 and May 2015. As communicated in October 2017, the BPA algorithm is a management tool and is intended to provide earlier notification of abnormal battery performance for battery advisory devices prior to premature battery depletion. Until now, detection of this alert has only been available through "Merlin.net" Remote Monitoring System and the Merlin Programmer during routine follow-up evaluations.

This firmware update now allows for device-based detection of abnormal battery performance. If BPA is triggered, a vibratory notification is delivered to the patient, thereby ensuring continuous monitoring in situations where adherence to transmission schedules is challenging (e.g., travel). Additionally, an alert will continue to be provided to physicians through the "Merlin.net" Remote Monitoring System and the Merlin Programmer during follow-up evaluations.

Affected products

A. Unify

Lot or serial number

All lots.

Model or catalog number
  • CD3235-40
  • CD3235-40Q
Companies
Manufacturer

St. Jude Medical, Cardiac Rhythm Management Division

15900 VALLEY VIEW COURT

Sylmar

91342

California

UNITED STATES

B. Fortify VR

Lot or serial number

All lots.

Model or catalog number
  • CD1233-40
  • CD1233-40Q
Companies
Manufacturer

St. Jude Medical, Cardiac Rhythm Management Division

15900 VALLEY VIEW COURT

Sylmar

91342

California

UNITED STATES

C. Fortify DR

Lot or serial number

All lots.

Model or catalog number
  • CD2233-40
  • CD2233-40Q
Companies
Manufacturer

St. Jude Medical, Cardiac Rhythm Management Division

15900 VALLEY VIEW COURT

Sylmar

91342

California

UNITED STATES

D. Fortify ST VR

Lot or serial number

All lots.

Model or catalog number
  • CD1235-40
  • CD1235-40Q
Companies
Manufacturer

St. Jude Medical, Cardiac Rhythm Management Division

15900 VALLEY VIEW COURT

Sylmar

91342

California

UNITED STATES

E. Fortify ST DR

Lot or serial number

All lots.

Model or catalog number
  • CD2235-40
  • CD2235-40Q
Companies
Manufacturer

St. Jude Medical, Cardiac Rhythm Management Division

15900 VALLEY VIEW COURT

Sylmar

91342

California

UNITED STATES

F. Unify Quadra Cardiac Resynchronization Device, Tiered-therapy Cardioverter/Defibrillator

Lot or serial number

All lots.

Model or catalog number
  • CD3251-40
  • CD3251-40Q
Companies
Manufacturer

St. Jude Medical, Cardiac Rhythm Management Division

15900 VALLEY VIEW COURT

Sylmar

91342

California

UNITED STATES

G. Fortify Assura DR

Lot or serial number

All lots.

Model or catalog number
  • CD2259-40
  • CD2259-40Q
  • CD2359-40C
  • CD2359-40QC
Companies
Manufacturer

St. Jude Medical, Cardiac Rhythm Management Division

15900 VALLEY VIEW COURT

Sylmar

91342

California

UNITED STATES

H. Fortify Assura VR

Lot or serial number

All lots.

Model or catalog number
  • CD1259-40
  • CD1259-40Q
  • CD1359-40C
  • CD1359-40QC
Companies
Manufacturer

St. Jude Medical, Cardiac Rhythm Management Division

15900 VALLEY VIEW COURT

Sylmar

91342

California

UNITED STATES

I. Unify Assura

Lot or serial number

All lots.

Model or catalog number
  • CD3261-40
  • CD3261-40Q
  • CD3361-40C
  • CD3361-40QC
Companies
Manufacturer

St. Jude Medical, Cardiac Rhythm Management Division

15900 VALLEY VIEW COURT

Sylmar

91342

California

UNITED STATES

J. Quadra Assura

Lot or serial number

All lots.

Model or catalog number
  • CD3367-40
  • CD3367-40C
  • CD3367-40Q
  • CD3367-40QC
Companies
Manufacturer

St. Jude Medical, Cardiac Rhythm Management Division

15900 VALLEY VIEW COURT

Sylmar

91342

California

UNITED STATES

K. Quadra Assura MP

Lot or serial number

All lots.

Model or catalog number
  • CD3371-40C
  • CD3371-40QC
Companies
Manufacturer

St. Jude Medical, Cardiac Rhythm Management Division

15900 VALLEY VIEW COURT

Sylmar

91342

California

UNITED STATES