FINELINE® II EZ Sterox 4469Recalls & reported problems

Summary

The FDA's MAUDE database contains 1,390 adverse event reports that list this exact device (DI 00802526265143), received between Jul 15, 2015 and Sep 24, 2026 — classified as 5 deaths, 1,145 injuries, 240 malfunctions.

The most frequently reported specific device problem is “High impedance” (176 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 1,390 reports, in the reporter's own words as published by the FDA.

• InjurySep 24, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that this cardiac resynchronization therapy pacemaker (CRT-P) system exhibited infection. Subsequently, the device and leads were explanted. No additional adverse patient effects were reported.

  Patient problems: Unspecified Infection

  MAUDE report 50889297 ↗
• InjurySep 24, 2026Device Dislodged or Dislocated; High Capture Threshold

  It was reported that this right atrial (RA) lead exhibited increased in pacing threshold measurement post implant. The sensing was exhibiting normally, however, due to microdislodgement which was confirmed via X ray and testing this RA lead was surgically revised. At this time, this RA lead remains in service. No additional adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50886216 ↗
• InjurySep 23, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that this right atrial (RA) lead was part of a system revision due to infection. There were no additional adverse patient effects reported. The RA lead was explanted.

  Patient problems: Unspecified Infection

  MAUDE report 50873897 ↗
• InjurySep 20, 2026Device Dislodged or Dislocated

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50834809 ↗
• InjurySep 16, 2026Over-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50793838 ↗
• InjurySep 15, 2026Insufficient Device Problem Information

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50777971 ↗
• MalfunctionSep 9, 2026Signal Artifact/Noise; High impedance

  Patient problems: Discomfort

  MAUDE report 50696918 ↗
• InjurySep 9, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that this implantable lead was part of the system revision due to infection. No adverse patient effects were reported. The implantable lead was explanted.

  Patient problems: Unspecified Infection

  MAUDE report 50685036 ↗
• InjurySep 8, 2026Insufficient Device Problem Information

  It was reported that, during a therapy upgrade procedure for the implantable cardioverter defibrillator (ICD), this right atrial (RA) lead was surgically abandoned due to unknown circumstances. The replacement procedure was successfully performed and a new lead was implanted instead. No additional adverse patient effects were reported outside the revision procedure.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50670291 ↗
• InjurySep 7, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection

  MAUDE report 50652675 ↗
• MalfunctionSep 4, 2026Low impedance; Device Dislodged or Dislocated; High Capture Threshold

  It was reported that this patient recently had an open-heart surgery and this right atrial (RA) impedance measurements were measuring around 400 Ohms. The physician wanted to find out of this system was magnetic resonance imaging (MRI) compatible. There was no evidence of fractured lead or compromised pulse generator-lead system integrity. Technical Services (TS) reviewed and stated that this RA lead exhibited high capture thresholds, measuring at 4.5V. This device was programmed at VDDR. TS stated that this system is not MRI compatible as the RA lead was dislodged. This lead remains in service. No adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50601353 ↗
• InjurySep 3, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that this right atrial (RA) lead was part of a system revision due to infection. There were no additional adverse patient effects reported. The RA lead was explanted.

  Patient problems: Unspecified Infection

  MAUDE report 50587571 ↗
• InjurySep 3, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that this implantable lead was part of the system revision due to infection. No adverse patient effects were reported. The implantable lead was explanted.

  Patient problems: Unspecified Infection

  MAUDE report 50586929 ↗
• InjurySep 2, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection

  MAUDE report 50566279 ↗
• InjuryAug 21, 2026Failure to Capture; Pacing Problem

  It was reported that a request was made to program this pacemaker system into magnetic resonance imaging (MRI) protection mode. Prior to programming, it was mentioned that it exhibited intermittent loss of capture (LOC) on the Right ventricular (RV) channel. Additionally, the patient was reported to be intubated. As a result, Technical Services (TS) discussed it would be an off label MRI. It was further reported that the pacemaker system sustained damage during cardiopulmonary resuscitation (CPR) and that the leads did not provided pacing. This right atrial (RA) lead remains in service. No additional adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50360691 ↗
• InjuryAug 19, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that this right atrial (RA) lead was part of a system revision due to infection. There was no additional adverse patient effects reported. The RA lead was explanted.

  Patient problems: Unspecified Infection

  MAUDE report 50326201 ↗
• InjuryAug 18, 2026Insufficient Device Problem Information

  It was reported that the right atrial (RA) lead was explanted due to unknown product performance anomaly. A new lead was implanted. No additional adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50290599 ↗
• InjuryAug 17, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that this right atrial (RA) lead was explanted with less than a year of use due to an infection. A new subcutaneous implantable cardioverter defibrillator (S-ICD) system was implanted and remains in service. No additional adverse patient effects were reported.

  Patient problems: Unspecified Infection

  MAUDE report 50280350 ↗
• InjuryAug 7, 2026High Capture Threshold

  It was reported that this right atrial (RA) lead exhibited elevated threshold measurement post-surgery cardiac surgery. The impedance and sensing values had remained normal. Subsequently, this RA lead was explanted, replaced with the same model and will be returned for analysis. No additional adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50181614 ↗
• MalfunctionAug 6, 2026Device Dislodged or Dislocated; High Capture Threshold

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50152760 ↗
• InjuryJul 31, 2026Insufficient Device Problem Information

  It was reported that this right atrial (RA) lead exhibited a nonspecific product performance anomaly. Subsequently, this lead was explanted and replaced. This product has not been returned for analysis. No additional adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50100611 ↗
• InjuryJul 30, 2026Off-Label Use; Material Integrity Problem

  It was reported that when replacing the associated device related to this right atrial (RA) lead insulation nicks were noted for which a silicone repair kit was used to fix the observed anomaly. Subsequently the implant pocket was irrigated using an antibiotic solution. The procedure was then successfully completed. This RA lead remains in service. Other than the intervention no adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50090678 ↗
• InjuryJul 29, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that this implantable lead was part of the system revision due to infection. No adverse patient effects were reported. The implantable lead was explanted.

  Patient problems: Unspecified Infection

  MAUDE report 50066072 ↗
• InjuryJul 28, 2026Signal Artifact/Noise; High impedance; Unexpected Therapeutic Results

  It was reported that this right atrial (RA) lead exhibited noise, impedance above 3000 ohms, and inappropriate pacing inhibition. The lead was surgically abandoned and a new product was implanted. No additional adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50057152 ↗
• InjuryJul 27, 2026High impedance; Pacing Problem; Unexpected Therapeutic Results

  It was reported that this right ventricular (RV) lead exhibited a product performance issue. The patient underwent a surgical intervention to deactivate the lead and implant a new product. The deactivated lead remains implanted. No additional adverse patient effects were reported. Additional information was surgically abandoned due to high impedance measurements greater than 3000 ohms and pacing inhibition. No additional adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50023776 ↗