Terminated

Unify, Model Numbers: CD3231-40 and CD3231-40Q; Unify Quadra, Model Numbers: CD3249-40 and CD3249-40Q; Unify Assura, Model Numbers: CD3257-40, CD3257-40Q, CD3357-40C, CD3357-40Q; Quadra Assura, Model Numbers: CD3265-40, CD3265-40Q, CD3365-40C, CD3365-40Q; Quadra Assura MP, Model Numbers: CD3269-40, CD3269-40Q, CD3369-40C, CD3369-40Q Unify and Unify Assura cardiac resynchronization therapy defibrillators (CRTDs) are intended to provide ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing, in additional to cardiac resynchronization therapy via left ventricular pacing

FDA Recall Z-0004-2018 · Posted 2017-10-10

Recalling FirmSt Jude Medical Inc.

Recall StatusTerminated

Product CodeNIK

Date Initiated2017-08-28

Date Terminated2024-01-20

Product Quantity89,109 units

Reason for Recall

The device may exhibit premature battery depletion.

Firm Action

Abbott sent a Field notification letter dated August 28, 2017 to customers of the availability of the new Battery Performance Alert. The letter identified the affected product, problem and actions to be taken. The recalling firm posted a public statement on their website in the Abbott Media Room. The link to the statement is as follows: http://abbott.mediaroom.com/2017-08-29-Abbott-issues-new-updates-for-implanted-cardiac-devices. For questions contact your local Sales Representative or Abbott Technical Services at 1-800-722-3774.

Root Cause

Device Design

Distribution Pattern

US Nationwide Distribution

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.