FDA Device recall Z-2420-2018
Medtronic EnTrust Escudo D144VRC (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 D144VRC (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-2420-2018 |
| 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 D144VRC (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: 00613994425027 Serial Numbers: PNT608737S PNT608738S PNT608739S PNT608740S PNT608742S PNT6087…Product UPN/GTIN: 00613994425027 Serial Numbers: PNT608737S PNT608738S PNT608739S PNT608740S PNT608742S PNT608743S PNT608744S PNT608745S PNT608746S PNT608748S PNT608749S PNT608750S PNT608751S PNT608752S PNT608753S PNT608754S PNT608755S PNT608756S PNT608757S PNT608758S PNT608759S PNT608760S PNT608761S PNT608762S PNT608763S PNT608764S PNT608765S PNT608766S PNT608767S PNT608768S PNT608769S PNT608770S PNT608771S PNT608772S PNT608773S PNT608774S PNT608775S PNT608776S PNT608777S PNT608778S PNT608779S PNT608780S PNT608781S PNT608782S PNT608783S PNT608784S PNT608785S PNT608786S PNT608787S PNT608788S PNT608789S PNT608790S PNT608791S PNT608792S PNT608793S PNT608794S PNT608795S PNT608796S PNT608798S PNT608799S PNT608800S PNT608801S PNT608802S PNT608803S PNT608804S PNT608805S PNT608806S PNT608807S PNT608808S PNT608809S PNT608810S PNT608830S PNT608924S PNT608926S PNT608927S PNT608930S PNT608931S PNT608932S PNT608934S |
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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-2420-2018%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.