SUREFIX® 5072-58Recalls & reported problems

Medtronic, Inc. · LEAD 5072-58 SUREFIX PACING LEAD US · Class 3 · Implant

All models of SUREFIX (3)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885074311883), received between Sep 3, 2024 and Sep 3, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Over-Sensing” (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 16, 2026.

Reports received per month

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

Most reported problems

Device problems

Over-Sensing1

Patient problems

No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

MalfunctionSep 3, 2024Over-Sensing; Over-Sensing
IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED SENSING INTEGRITY COUNTER (SIC). THE RV 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 20128312 ↗

Device details

UDI-DI	`00885074311883`
Brand	SUREFIX®
Model	5072-58
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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All Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes devices →

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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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