FDA Device recall Z-0116-2017
Unify, Model No. CD3231-40, CD3231-40Q. Unify Quadra, Model No. CD3249-40, CD3249-40Q. Unify Assura, Model No. CD3257-40, CD3357-40C, CD335…
- FDA Device
- Class I
- terminated
- Published 2016-11-02
On 2016-11-02 the FDA classified a Class I recall of Unify, Model No. CD3231-40, CD3231-40Q. Unify Quadra, Model No. CD3249-40, CD3249-40Q. Unify Assura, Model No. CD3257-40, CD3357-40C, CD335… by St Jude Medical, citing st Jude Medical is recalling implantable cardiac defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) devices because they are subject to premature batt….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0116-2017 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2016-10-10 |
| Published | 2016-11-02 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | St Jude Medical |
| Distribution | US |
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
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.
Identifiers
| code_info | Serial 591053 591054 591055 591056 591057 591058 591059 591060 591061 591062 591063 591064 591065 591066…Serial 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 591137 591138 591139 591140 591141 591142 591143 591144 591145 591146 591147 591148 591149 591150 591151 591152 591153 591154 591155 591156 591157 591158 591159 591160 591161 591162 591163 591164 591235 591236 591237 591238 591239 591240 591241 591242 591243 591244 591245 591246 591247 591248 591249 591250 591251 591252 591253 591254 591255 591256 591257 591258 591259 591260 591261 591262 591263 591264 591265 591266 591267 591268 591269 591270 591271 591272 591273 591274 591275 591276 591277 591278 591338 591339 591340 591341 591342 591343 591344 591345 591346 591347 591348 591349 591350 591351 591352 591353 591354 591355 591356 591357 591358 591359 591360 591361 591362 591363 591364 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0116-2017%22
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