Ellipse™ CD2275-36QRecalls & reported problems

St. Jude Medical, Inc. · Tiered-therapy cardioverter/defibrillator VVEV VVIR · Class 3 · Implant

All models of Ellipse (12)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports: 2
Deaths reported: 0
Injuries reported: 2
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05414734505918), received between Sep 6, 2018 and Jun 19, 2023 — classified as 2 injuries.

The most frequently reported specific device problem is “Connection Problem” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Device problems

Connection Problem1
Failure to Convert Rhythm1
Inappropriate/Inadequate Shock/Stimulation1
Incorrect Interpretation of Signal1
Migration1

Patient problems

Discomfort1
No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

InjuryJun 19, 2023Failure to Convert Rhythm; Incorrect Interpretation of Signal; Inappropriate/Inadequate Shock/Stimulation; Failure to Convert Rhythm; Incorrect Interpretation of Signal; Inappropriate/Inadequate Shock/Stimulation
IT WAS REPORTED THAT THE PATIENT RECEIVED INAPPROPRIATE ANTI-TACHYCARDIA PACING AND HIGH VOLTAGE (HV) SHOCK DUE TO A SUPRAVENTRICULAR TACHYCARDIA (SVT) RHYTHM. THE HV SHOCK INDUCED VENTRICULAR TACHYCARDIA (VT) WHICH WAS UNABLE TO BE TERMINATED BY THE DEVICE WITH AN ADDITIONAL HV SHOCK. THE DEVICE WAS REPROGRAMMED TO RESOLVE THE EVENT. THE PATIENT WAS STABLE.
Patient problems: Discomfort
MAUDE report 17152826 ↗
InjurySep 6, 2018Connection Problem; Migration; Connection Problem; Migration
DURING A FOLLOW-UP IN CLINIC, THERE WAS DECREASED SENSING AND AN INCREASED CAPTURE THRESHOLD NOTED ON THE RIGHT VENTRICULAR (RV) LEAD. DIAGNOSTIC IMAGING WAS PERFORMED AND REVEALED THAT THE DEVICE HAD MIGRATED IN THE POCKET AND CAUSED BOTH THE RV AND RIGHT ATRIAL (RA) LEADS TO DISLODGE. A SURGERY WAS PERFORMED TO ADDRESS THE DISLODGEMENT AND THE SENSING VALUE OF THE RA LEAD DECREASED. BOTH LEADS WERE THEN EXPLANTED AND REPLACED. WHEN THE NEW LEADS WERE BEING RECONNECTED TO THE OLD DEVICE, THE RV LEAD COULD NOT BE PLACED IN THE DEVICE HEADER, SO THE DEVICE WAS ALSO REPLACED. THE PATIENT WAS STABLE FOLLOWING THE PROCEDURE AND SUFFERED NO ADVERSE CONSEQUENCES DUE TO THE EVENT. RELATED MANUFACTURER REPORT NUMBERS: 2938836-2018-10423, 2938836-2018-10424.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7850709 ↗

Device details

UDI-DI	`05414734505918`
Brand	Ellipse™
Model	CD2275-36Q
Company	St. Jude Medical, Inc.
Product code	NVZ · Pulse generator, permanent, implantable
Class	Class 3
FDA submission	None listed
Implant	Yes
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Feb 5, 2021

Device type (GMDN): Dual-chamber implantable defibrillator

A battery-powered, hermetically-sealed pulse generator with a cardiac rhythm recognition system intended to collect and analyse electrocardiogram (ECG) data and deliver appropriate electrical impulses to defibrillate the heart (restore normal rhythm) or slow a rapid heart rate, and to pace the heart (to treat bradycardia). It is implanted in a pouch beneath the skin of the patient's chest or abdomen and intended to be used with leads that are positioned inside the right atrium and right ventricle to monitor the ECG and to automatically deliver the electrical impulse; it is commonly known as an automatic implantable cardioverter-defibrillator (AICD).

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Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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