Medtronic EnTrust SingleChamber Implantable Cardioverter… — Class II medical device recall Z-2419-2018
Terminated recall by Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF), reported 2018-07-18, distributed nationwide. Medtronic has become aware of a potential for loss of high voltage and anti-tachycardia pacing therapy in EnTr
| Recall number | Z-2419-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF), Mounds View, MN, United States |
| Recall initiated | 2018-06-21 |
| Classified | 2018-07-10 |
| Reported by FDA | 2018-07-18 |
| Terminated | 2021-06-16 |
| Distributed | Nationwide (US) |
| Quantity | 8,821 units |
| UPC / GTIN / UDI-DI | 00885074300252, 00885074300276, 00885074300290 |
| Serial numbers | 278S, PNR428538H, PNT400133H, PNT400147H, PNT400445H, PNT400460H, PNT400466H, PNT400623H, PNT400738H, PNT400825H, PNT401088H, PNT401266H, PNT401333H, PNT401480H, PNT401643H, PNT401701H, PNT401708H, PNT401789H, PNT401844H, PNT402040H, PNT402100H, PNT402299H, PNT402301H, PNT402306H, PNT402307H and 475 more |
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 for recall
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.
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-2419-2018. 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.