FDA Device recall Z-2417-2018
Medtronic EnTrust Dual Chamber Implantable Cardioverter Defibrillator with Atrial and Ventricular Therapies and RapidRead Telemetry, D154AT…
- FDA Device
- Class II
- terminated
- Published 2018-07-18
On 2018-07-18 the FDA classified a Class II recall of Medtronic EnTrust Dual Chamber Implantable Cardioverter Defibrillator with Atrial and Ventricular Therapies and RapidRead Telemetry, D154AT… 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-2417-2018 |
| 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 Dual Chamber Implantable Cardioverter Defibrillator with Atrial and Ventricular Therapies and RapidRead Telemetry, D154ATG Product Usage: The device indicated for use in ICD patients with atrial tachyarrhythmias, or who are at significant risk of developing atrial tachyarrhythmias. 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: 00613994170927 Serial Numbers: PNR606917S PNR606918S PNR606923S Product UPN/GTIN: 0088507429…Product UPN/GTIN: 00613994170927 Serial Numbers: PNR606917S PNR606918S PNR606923S Product UPN/GTIN: 00885074299938 Serial Numbers: PNR414990H PNR417905H PNR600110S PNR600121S PNR600123S PNR600136S PNR600141S PNR600147S PNR600148S PNR600157S PNR600163S PNR600166S PNR600176S PNR600177S PNR600183S PNR600189S PNR600190S PNR600192S PNR600194S PNR600195S PNR600198S PNR600203S PNR600290S PNR600306S PNR600381S PNR600382S PNR600383S PNR600385S PNR600387S PNR600388S PNR600389S PNR600390S PNR600392S PNR600393S PNR600396S PNR600397S PNR600398S PNR600401S PNR600402S PNR600404S PNR600405S PNR600406S PNR600407S PNR600409S PNR600410S PNR600412S PNR600415S PNR600416S PNR600417S PNR600418S PNR600419S PNR600422S PNR600423S PNR600424S PNR600425S PNR600426S PNR600427S PNR600428S PNR600429S PNR600432S PNR600433S PNR600434S PNR600435S PNR600436S PNR600437S PNR600438S PNR600439S PNR600441S PNR600442S PNR600443S PNR600448S PNR600 |
|---|
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-2417-2018%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.