Fortify VR — Class I medical device recall Z-0003-2018
Terminated recall by St Jude Medical Inc., reported 2017-10-18, distributed nationwide. The device may exhibit premature battery depletion.
| Recall number | Z-0003-2018 |
|---|---|
| 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 | 90,563 units |
| Serial numbers | 1000237, 1000243, 1000246, 1011641, 1011643, 1011644, 1011646, 1011649, 1011653, 1011654, 1011655, 1011656, 1011660, 1011661, 1022714, 1022716, 1022717, 1022718, 1022719, 1022720, 1022723, 1022724, 1022726, 1022728, 1022729 and 475 more |
| Model numbers | CD1231-40, CD1231-40Q, CD1241-40, CD1241-40Q, CD1257-40, CD1257-40Q, CD1263-40, CD1263-40Q, CD1357-40C, CD1357-40Q, CD1363-40C, CD1363-40Q, CD2231-40, CD2231-40Q, CD2241-40, CD2241-40Q, CD2257-40, CD2257-40Q, CD2263-40, CD2263-40Q, CD2357-40C, CD2357-40Q, CD2363-40C, CD2363-40Q |
Product
Fortify VR - Model Numbers: CD1231-40 and CD1231-40Q; Fortify ST VR, Model Numbers: CD1241-40 and CD1241-40Q; Fortify Assura VR, Model Numbers: CD1257-40, CD1257-40Q, CD1357-40C, CD1357-40Q; Fortify Assura ST VR, Model Numbers: CD1263-40, CD1263-40Q, CD1363-40C, CD1363-40Q; Fortify DR, Model Numbers: CD2231-40 and CD2231-40Q; Fortify ST DR, Model Numbers: CD2241-40 and CD2241-40Q; Fortify Assura DR, Model Numbers: CD2257-40, CD2257-40Q, CD2357-40C, CD2357-40Q; Fortify Assura ST DR, Model Numbers: CD2263-40, CD2263-40Q, CD2363-40C, CD2363-40Q Product Usage 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
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-0003-2018. 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.