Unify, Model Numbers: CD3231-40 and CD3231-40Q; Unify Quadra, Model Numbers: CD3249-40 and CD3249-40Q; Unify Assura, Mod
FDA device recall Z-0004-2018 · posted 2017-10-10 · Terminated
Recall details
- Recalling firm
- St Jude Medical Inc.
- Reason for recall
- The device may exhibit premature battery depletion.
- Action taken
- 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
- Status
- Terminated
- Product code
- NIK
- Quantity affected
- 89,109 units
- Distribution
- US Nationwide Distribution
- Date initiated
- 2017-08-28
- Date posted
- 2017-10-10
- Date terminated
- 2024-01-20
- Location
- Sylmar, CA
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