Unify — Class I medical device recall Z-0116-2017
Terminated recall by St Jude Medical Inc., reported 2016-11-02, distributed nationwide. St Jude Medical is recalling implantable cardiac defibrillator (ICD) and cardiac resynchronization therapy def
| Recall number | Z-0116-2017 |
|---|---|
| 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 | 2016-10-10 |
| Classified | 2016-10-21 |
| Reported by FDA | 2016-11-02 |
| Terminated | 2018-09-27 |
| Distributed | Nationwide (US) |
| Quantity | 204,785 units |
| Reason classes | device malfunction |
| Serial numbers | 591053, 591054, 591055, 591056, 591057, 591058, 591059, 591060, 591061, 591062, 591063, 591064, 591065, 591066, 591067, 591068, 591069, 591070, 591071, 591072, 591132, 591133, 591134, 591135, 591136 and 475 more |
| Model numbers | CD3231-40, CD3231-40Q, CD3249-40, CD3249-40Q, CD3257-40, CD3357-40C, CD3357-40Q |
Product
Unify, Model No. CD3231-40, CD3231-40Q. Unify Quadra, Model No. CD3249-40, CD3249-40Q. Unify Assura, Model No. CD3257-40, CD3357-40C, CD3357-40Q. Fortify and Fortify Assura implantable cardioverter defibrillators (ICDS) are intended to provided 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. 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
St Jude Medical is recalling implantable cardiac defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) devices because they are subject to premature battery depletion due to lithium cluster with the battery causing a short circuit.
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-0116-2017. 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.