NA 5833SL (UDI 00681490136365)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00681490136365), received between May 15, 2018 and Dec 21, 2022 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (6 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 16, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 21, 2022Material Integrity Problem; Material Integrity Problem

  IT WAS FURTHER REPORTED THAT THE CABLE HAD BEEN DISCARDED INADVERTENTLY BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16020886 ↗
• MalfunctionDec 16, 2022Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE CABLE GAVE OUT OF RANGE IMPEDANCES FOR ATRIAL (A) AND RIGHT VENTRICULAR (RV) MEASURES DURING IMPLANT. ANOTHER CABLE WAS TRIED FROM THE SAME LOT AND RIGHT ATRIAL (RA) AND RIGHT VENTRICULAR (RV) MEASURES CONTINUED TO PROVIDE VALUES GREATER THAN 4000 OHMS. IT WAS NOTED THAT MEASURES THROUGH THE DEVICE AND THROUGH THE FACILITY'S ANALYZER CABLE WERE WITHIN NORMAL LIMITS. THE USER ATTEMPTED UNPLUGGING AND RE-PLUGGING, SWITCHING THE CABLES FROM ATRIAL TO VENTRICULAR AND VICE VERSA BUT THE ISSUE PERSISTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15994580 ↗
• MalfunctionDec 16, 2022Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE CABLE GAVE OUT OF RANGE IMPEDANCES FOR ATRIAL (A) AND RIGHT VENTRICULAR (RV) MEASURES DURING IMPLANT. ANOTHER CABLE WAS TRIED FROM THE SAME LOT AND RIGHT ATRIAL (RA) AND RIGHT VENTRICULAR (RV) MEASURES CONTINUED TO PROVIDE VALUES GREATER THAN 4000 OHMS. IT WAS NOTED THAT MEASURES THROUGH THE DEVICE AND THROUGH THE FACILITY'S ANALYZER CABLE WERE WITHIN NORMAL LIMITS. THE USER ATTEMPTED UNPLUGGING AND RE-PLUGGING, SWITCHING THE CABLES FROM ATRIAL TO VENTRICULAR AND VICE VERSA BUT THE ISSUE PERSISTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15994553 ↗
• MalfunctionOct 20, 2022Impedance Problem; Impedance Problem

  IT WAS REPORTED THAT DURING IMPLANT OF THE RIGHT VENTRICULAR (RV) LEAD WHEN CONNECTED TO ANALYZER, CABLE AND ADAPTER, THE IMPEDANCE MEASUREMENTS WERE SWITCHED WHERE THE UNIPOLAR WAS GREATER THAN THE BIPOLAR. IT WAS FURTHER REPORTED THAT THE ISSUE WAS RESOLVED AFTER THE LEAD WAS CONNECTED TO THE DEVICE. IT WAS SUSPECTED THAT THE IMPEDANCE ISSUE WAS DUE TO THE CABLE OR ADAPTER. THE CABLE AND ADAPTER WERE DISCARDED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15638465 ↗
• MalfunctionApr 7, 2021Failure to Capture; Impedance Problem; Material Integrity Problem; Failure to Capture; Impedance Problem; Material Integrity Problem

  IT WAS REPORTED THAT WHEN THE CABLES WERE ATTACHED TO THE PATIENT LEAD DURING A GENERAL CHANGE, NO CAPTURE OR ACCURATE IMPEDANCE WAS RECORDED ON ANALYZER. P AND R WAVE SENSING MEASUREMENTS DID APPEAR. IT WAS CONFIRMED WITH THE PHYSICIAN THAT THE CABLES WERE ATTACHED TO THE LEAD CORRECTLY AND THAT THE GREY ATTACHMENT WAS CORRECTLY INSERTED INTO THE MOBILE PROGRAMMER. THE CABLES WERE TRIED IN BOTH THE ATRIAL AND VENTRICULAR PORTS WITH THE SAME RESULTS. WHEN THE LEADS WERE CONNECTED TO THE IMPLANTABLE DEVICE ALL TESTING WAS WITHIN NORMAL LIMITS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11626326 ↗
• InjuryJun 15, 2018No Device Output; Device Sensing Problem; Inadequate User Interface; Material Integrity Problem; No Device Output; Device Sensing Problem; Inadequate User Interface; Material Integrity Problem

  IT WAS REPORTED THAT HEART RHYTHM TRACINGS (INTERCARDIAC) WERE UNABLE TO BE OBTAINED WHEN THE CABLE WAS IN USE AND THAT THE CABLE WAS UNABLE TO PACE. THE CABLE WAS RETURNED TO SERVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7605750 ↗
• MalfunctionMay 15, 2018Device Operates Differently Than Expected; Material Integrity Problem; Device Operates Differently Than Expected; Material Integrity Problem

  IT WAS REPORTED THAT DEVICE TESTING WAS UNABLE TO BE PERFORMED USING THIS CABLE. A DIFFERENT CABLE WAS ABLE TO BE USED WITH NO ISSUE. THE CABLE WAS RETURNED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7516706 ↗