FINELINE® II EZ Sterox 4471Recalls & reported problems

Summary

The FDA's MAUDE database contains 964 adverse event reports that list this exact device (DI 00802526265006), received between Nov 3, 2013 and Sep 30, 2026 — classified as 1 death, 718 injuries, 245 malfunctions.

The most frequently reported specific device problem is “High Capture Threshold” (184 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 964 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026High impedance

  It was reported that the pacemaker and this right ventricular (RV) lead exhibited a Red Call Doctor Icon (RCD). The RCD was recorded due to a high out of range pacing impedance measurement, greater than 3000 Ohms. This RV lead remains in service. No adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50951587 ↗
• InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection

  MAUDE report 50941320 ↗
• MalfunctionSep 25, 2026Failure to Capture; High Capture Threshold

  It was reported that the pacemaker and this right ventricular (RV) lead right ventricular automatic threshold (RVAT) test was suspended due to a loss of capture. Also, Technical Services (TS) suspected this pacemaker stored inappropriate ventricular episodes due to an atrial arrythmia with rapid ventricular response (RVR). TS also noted the last RVAT was above programmed outputs and was trending upwards. TS discussed the loss of capture with the health care professional (HCP). The HCP planned to consult with cardiology. This RV lead remains in service. No adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50897299 ↗
• InjurySep 25, 2026Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 50897005 ↗
• 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 50889292 ↗
• MalfunctionSep 23, 2026High impedance

  It was reported that this pacemaker was alerted that a lead safety switch (LSS) from bipolar to unipolar configurations was triggered due to high out of range pacing impedance measurements on the right ventricular (RV) lead were recorded. The health care professional (HCP) called Technical Services (TS) for further review of daily threshold and impedance measurements trend report. Upon review, the device data showed RV lead pacing impedances were stable within normal limits except for two instances that caused the LSS. The presenting electrogram (EGM) showed no noise events and isometrics was unable to reproduce the high out of range pacing impedances. TS discussed possible causes and provided programming recommendations. No adverse patient effects were reported. At this time, this RV lead and pacemaker remain in service.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50873392 ↗
• MalfunctionSep 16, 2026Failure to Capture; High Capture Threshold

  It was reported that this left ventricular (LV) lead exhibited loss of capture (LOC) and high capture thresholds. Technical Services (TS) recommended bringing the patient into the clinic to be evaluated. The patient was evaluated and the device was reprogrammed. No adverse patient effects were reported. This lead remains in service.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50792014 ↗
• MalfunctionSep 11, 2026Signal Artifact/Noise; High impedance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50736136 ↗
• MalfunctionSep 8, 2026Failure to Capture

  Patient problems: Bradycardia; Dizziness; Presyncope

  MAUDE report 50666609 ↗
• InjurySep 4, 2026Signal Artifact/Noise; High impedance; Over-Sensing; Pacing Problem

  It was reported that this right ventricular (RV) lead exhibited a lead safety switch (LSS) to unipolar configuration after high out of range pacing impedance measurements above 2000 Ohms were recorded. Technical Services (TS) was consulted and determined that the pacing impedance measurements had increased gradually overtime. Following the LSS multiple episodes of noise were recorded, resulting in pacing inhibition of up to five seconds. Subsequently, this lead was surgically abandoned and successfully replaced. No additional adverse patient effects were reported.

  Patient problems: Asystole

  MAUDE report 50602365 ↗
• MalfunctionSep 4, 2026Failure to Capture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50602290 ↗
• InjuryAug 17, 2026Failure to Capture; Device Dislodged or Dislocated; High Capture Threshold

  It was reported that this right ventricular (RV) lead exhibited loss of capture and elevated thresholds as the patient had twiddled their device until both leads were turned and twisted. The device was reprogrammed to a higher output to allow capture. The patient underwent a surgical intervention to remove this pacemaker system and approximately a week later was implanted with a new cardiac resynchronization therapy defibrillator (CRT-D) system. No additional adverse patient effects were reported.

  Patient problems: Presyncope; Twiddlers Syndrome

  MAUDE report 50284726 ↗
• MalfunctionAug 17, 2026High impedance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50278461 ↗
• MalfunctionAug 12, 2026Signal Artifact/Noise; Failure to Capture; Over-Sensing; Failure to Read Input Signal; Under-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50225888 ↗
• InjuryAug 6, 2026Insufficient Device Problem Information

  It was reported that this right ventricular (RV) lead was explanted due to unspecified reasons. It is unknown when this lead was explanted. No additional adverse patient effects were reported outside the revision procedure. This product was received by the BSC laboratory for analysis.

  Patient problems: Foreign Body In Patient

  MAUDE report 50166243 ↗
• InjuryJul 7, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS PART OF A SYSTEM REVISION DUE TO INFECTION. THERE WAS NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE RV LEAD WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 25741914 ↗
• InjuryJun 30, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT THIS LEFT BUNDLE BRANCH (LBB) 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25673585 ↗
• InjuryJun 23, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS RIGHT VENTRICULAR (RV) LEAD EXPERIENCED PAIN WHEN PACING AFTER HAVING A BAD FALL. THE PHYSICIAN WAS NOT REALLY SURE WHAT WAS WRONG. SUBSEQUENTLY, THIS LEAD WAS EXPLANTED AND REPLACED. A NEW LEAD WAS IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Fall; Pain

  MAUDE report 25591904 ↗
• MalfunctionJun 12, 2026Over-Sensing; Extracardiac stimulation

  IT WAS REPORTED THAT THE PATIENT WITH THIS RIGHT VENTRICULAR (RV) LEAD EXPERIENCED POCKET STIMULATION. THE DEVICE EXPERIENCED MINUTE VENTILATION SIGNAL OVERSENSING. THE LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Device Overstimulation of Tissue

  MAUDE report 25493732 ↗
• MalfunctionJun 11, 2026Failure to Capture

  IT WAS REPORTED THAT THE HEALTH CARE PROFESSIONAL (HCP) SUSPECTED THIS PACEMAKER SYSTEM EXHIBITED LOSS OF CAPTURE (LOC) ON THE RIGHT VENTRICULAR (RV) CHANNEL. TECHNICAL SERVICES (TS) REVIEWED THE DATA AND NOTED THERE WAS ACTIVITY ON BOTH CHANNELS. TS RECOMMENDED AN IN-OFFICE INTERROGATION TO CONFIRM IF THERE WAS CAPTURE. THIS RV LEAD REMAINS IN SERVICE AND NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25478172 ↗
• InjuryApr 22, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS EXPLANTED DUE TO AN UNKNOWN PRODUCT PERFORMANCE ANOMALY. A NEW REPLACEMENT LEAD WAS IMPLANTED SUCCESSFULLY. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24956179 ↗
• InjuryMar 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS BUNDLE OF HIS LEAD WAS PART OF A SYSTEM REVISION DUE TO INFECTION. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THIS BUNDLE OF HIS LEAD WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 24728762 ↗
• InjuryMar 26, 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 24706041 ↗
• MalfunctionMar 21, 2026High impedance; Off-Label Use

  IT WAS REPORTED THAT DURING A DEVICE CHECK OF THIS PACEMAKER SYSTEM PRIOR TO MAGNETIC RESONANCE IMAGING (MRI) SCAN, HIGH OUT-OF-RANGE PACE IMPEDANCE MEASUREMENTS GREATER THAN 2,000 OHMS ON THE RIGHT VENTRICULAR (RV) LEAD. REVIEW PACE IMPEDANCE TRENDS SHOWED A GRADUAL RISE IN MEASUREMENTS SINCE (B)(6) 2025 THAT WAS SUSPECTED TO ATTRIBUTED TO A PHYSIOLOGIC CAUSE. IT WAS NOTED THAT THE CLINIC WAS MONITORING THE RV LEAD, WITH PLANS FOR LEAD REVISION AT THE NEXT ROUTINE BATTERY REPLACEMENT. IT WAS CONFIRMED THAT THE NON-CONDITIONAL MRI SCAN WAS COMPLETED WITH APPROPRIATE ORDERS. THIS RV LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS OR INTERVENTIONS WERE REPORTED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24656839 ↗
• InjuryMar 10, 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 24565699 ↗