SUREFIX® 5072-52Recalls & reported problems

Medtronic, Inc. · LEAD 5072-52 SUREFIX PACING LEAD US · Class 3 · Implant

Adverse event reports: 5
Deaths reported: 0
Injuries reported: 3
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00885074311876), received between Aug 9, 2017 and May 28, 2025 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Over-Sensing” (2 reports).

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. How this data works · Data updated Oct 13, 2026.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Over-Sensing2
Signal Artifact/Noise2
Capturing Problem1
High Capture Threshold1
Intermittent Capture1
Under-Sensing1

Patient problems

No Clinical Signs, Symptoms or Conditions3
No Known Impact Or Consequence To Patient1
Syncope/Fainting1

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

MalfunctionMay 28, 2025Over-Sensing; Over-Sensing
IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED FAR FIELD R-WAVE (FFRW) OVERSENSING. THE RA LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22096544 ↗
InjurySep 3, 2024Signal Artifact/Noise; Over-Sensing; Signal Artifact/Noise; Over-Sensing
IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED NOISE AND FAR FIELD R-WAVE (FFRW) OVERSENSING. THE RA LEAD WAS CAPPED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20123204 ↗
InjuryMay 22, 2023Intermittent Capture; Capturing Problem; High Capture Threshold; Intermittent Capture; Capturing Problem; High Capture Threshold
IT WAS REPORTED THAT THE PATIENT EXPERIENCED SYNCOPE DUE TO INTERMITTENT CAPTURE ON THE RIGHT VENTRICULAR (RV) LEAD. IT WAS NOTED THAT THE RV LEAD HAD HIGH THRESHOLDS AND THAT THE THRESHOLDS ROSE, LEADING TO INTERMITTENT CAPTURE. THE RV LEAD WAS CAPPED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: Syncope/Fainting
MAUDE report 16974405 ↗
MalfunctionMar 1, 2023Under-Sensing; Under-Sensing
IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING. IT WAS ALSO NOTED THAT THE RA UNDERSENSING DISRUPTED THE DISCRIMINATORS AND CAUSED INAPPROPRIATE ANTI-TACHYCARDIA PACING THERAPY. THE RA LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16460248 ↗
InjuryAug 9, 2017Signal Artifact/Noise; Signal Artifact/Noise
IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD AND RIGHT VENTRICULAR (RV) LEAD HAD NOISE. THE LEADS WERE BOTH EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6783171 ↗

Device details

UDI-DI	`00885074311876`
Brand	SUREFIX®
Model	5072-52
Company	Medtronic, Inc.
Product code	NVN · Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
Class	Class 3
FDA submission	P930039
Implant	Yes
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	Not in Commercial Distribution
Record updated	Mar 20, 2024

Device type (GMDN): Endocardial/interventricular septal pacing lead

An implantable wire with an electrode, insulated with non-conductive material except at its ends, which serves as an electrical conductor to transmit pacing impulses from an implanted pulse generator to the heart; it is not intended to conduct defibrillation impulses. It may transmit intrinsic electrical activity from the heart back to the pulse generator. The electrode end is normally placed through a vein to contact the endocardium where it is fixed, or to penetrate the myocardium of the interventricular septum adjacent to the HIS-Purkinje system; the other end is connected to the pulse generator. It may be impregnated with a steroid intended to reduce inflammation.

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.