FDA Device recall Z-2419-2018
Medtronic EnTrust SingleChamber Implantable Cardioverter Defibrillator with Atrial and Ventricular Therapies and RapidRead Telemetry, D154V…
- FDA Device
- Class II
- terminated
- Published 2018-07-18
On 2018-07-18 the FDA classified a Class II recall of Medtronic EnTrust SingleChamber Implantable Cardioverter Defibrillator with Atrial and Ventricular Therapies and RapidRead Telemetry, D154V… 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-2419-2018 |
| 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 SingleChamber Implantable Cardioverter Defibrillator with Atrial and Ventricular Therapies and RapidRead Telemetry, D154VRC 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: 00885074300252 Serial Numbers: PNT600036S PNT600042S PNT600053S PNT600056S PNT600057S PNT6000…Product UPN/GTIN: 00885074300252 Serial Numbers: PNT600036S PNT600042S PNT600053S PNT600056S PNT600057S PNT600059S PNT600063S PNT600064S PNT600067S PNT600070S PNT600072S PNT600077S PNT600078S PNT600084S PNT600086S PNT600088S PNT600089S PNT600090S PNT600093S PNT600094S PNT600097S PNT600100S PNT600101S PNT600102S PNT600103S PNT600104S PNT600105S PNT600107S PNT600108S PNT600109S PNT600111S PNT600113S PNT600115S PNT600118S PNT600119S PNT600135S PNT600157S PNT600159S PNT600160S PNT600161S PNT600167S PNT600169S PNT600171S PNT600177S PNT600179S PNT600180S PNT600181S PNT600182S PNT600183S PNT600184S PNT600185S PNT600186S PNT600187S PNT600188S PNT600189S PNT600192S PNT600193S PNT600194S PNT600195S PNT600198S PNT600201S PNT600202S PNT600203S PNT600205S PNT600207S PNT600209S PNT600210S PNT600211S PNT600212S PNT600213S PNT600216S PNT600217S PNT600218S PNT600219S PNT600220S PNT600221S PNT600223S PNT600225S PNT600226S |
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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-2419-2018%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.