Unify — Class I medical device recall Z-0004-2018
Terminated recall by St Jude Medical Inc., reported 2017-10-18, distributed nationwide. The device may exhibit premature battery depletion.
| Recall number | Z-0004-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | St Jude Medical Inc., Sylmar, CA, United States |
| Recall initiated | 2017-08-28 |
| Classified | 2017-10-10 |
| Reported by FDA | 2017-10-18 |
| Terminated | 2024-01-20 |
| Distributed | Nationwide (US) |
| Quantity | 89,109 units |
| Serial numbers | 1000251, 1000258, 1000265, 1000268, 1000780, 1000782, 1000790, 1000797, 1000802, 1000812, 1000834, 1000839, 1000850, 1000853, 1000865, 1000875, 1000878, 1001608, 1001627, 1001632, 1001636, 1001637, 1001648, 1001652, 1001653 and 475 more |
| Model numbers | CD3231-40, CD3231-40Q, CD3249-40, CD3249-40Q, CD3257-40, CD3257-40Q, CD3265-40, CD3265-40Q, CD3269-40, CD3269-40Q, CD3357-40C, CD3357-40Q, CD3365-40C, CD3365-40Q, CD3369-40C, CD3369-40Q |
Product
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
Reason for recall
The device may exhibit premature battery depletion.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0004-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.