FDA Device recall Z-2421-2018
Medtronic EnTrust Escudo D144DRG (OUS distribution) Product Usage: The implantable cardioverter defibrillator is intended to provide ventri…
- FDA Device
- Class II
- terminated
- Published 2018-07-18
On 2018-07-18 the FDA classified a Class II recall of Medtronic EnTrust Escudo D144DRG (OUS distribution) Product Usage: The implantable cardioverter defibrillator is intended to provide ventri… by Medtronic Cardiac Rhythm And Heart Failure Crhf, citing medtronic has become aware of a potential for loss of high voltage and anti-tachycardia pacing therapy in EnTrust and Escudo implantable cardioverter defibrillators (ICDs) as they….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2421-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-06-21 |
| Published | 2018-07-18 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Medtronic Cardiac Rhythm And Heart Failure Crhf |
| Distribution | US |
Product
Medtronic EnTrust Escudo D144DRG (OUS distribution) Product Usage: The implantable cardioverter defibrillator is intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias.
Reason
Medtronic has become aware of a potential for loss of high voltage and anti-tachycardia pacing therapy in EnTrust and Escudo implantable cardioverter defibrillators (ICDs) as they near elective replacement indicator (ERI) voltage. Under certain circumstances, the device may display an immediate End of Life (EOL) Observation with no prior ERI alert. Though no ERI alert is triggered, there may not be enough remaining battery capacity to charge the high voltage circuits, resulting in an excessive charge time EOL Observation, leading to a loss of high voltage and anti-tachycardia pacing therapy.
Identifiers
| code_info | Product UPN/GTIN: 00613994425010 Serial Numbers: PNR611652S PNR611653S PNR611654S PNR611655S PNR611656S PNR6116…Product UPN/GTIN: 00613994425010 Serial Numbers: PNR611652S PNR611653S PNR611654S PNR611655S PNR611656S PNR611657S PNR611658S PNR611659S PNR611661S PNR611662S PNR611663S PNR611664S PNR611665S PNR611666S PNR611667S PNR611669S PNR611670S PNR611671S PNR611672S PNR611673S PNR611674S PNR611675S PNR611724S PNR611726S PNR611728S PNR611730S PNR611734S PNR611735S PNR611738S PNR611743S PNR611746S PNR611749S PNR611750S PNR611751S PNR611752S PNR611753S PNR611754S PNR611755S PNR611756S PNR611757S PNR611758S PNR611759S PNR611761S PNR611762S PNR611763S PNR611764S PNR611765S PNR611767S PNR611768S PNR611861S PNR611862S PNR611863S PNR611864S PNR611865S PNR611866S PNR611867S PNR611868S PNR611869S PNR611870S PNR611871S PNR611872S PNR611873S PNR611875S PNR611876S PNR611877S PNR611878S PNR611879S PNR611880S PNR611881S PNR611883S PNR611884S PNR611885S PNR611886S PNR611888S PNR611889S PNR611891S PNR611892S PNR611893S PNR611894S |
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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-2421-2018%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.