C/IS-10Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00836559002611), received between Mar 10, 2021 and Jan 25, 2022 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (4 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.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 25, 2022Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR AN IMPLANT PROCEDURE. DURING THE PROCEDURE, IT WAS NOTED THAT THE ADAPTOR EXHIBITED A FITTING ISSUE. THE ADAPTOR WAS NOT USED AND WAS REPLACED. WHEN THE SECOND ADAPTOR WAS USED THE SAME PROBLEM WAS ENCOUNTERED. THE PHYSICIAN THEN LOOSENED THE SCREW ON THE HEADER AND WAS ABLE TO FIT IN THE ADAPTOR. THE PATIENT WAS IN STABLE CONDITION THROUGHOUT THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13343560 ↗
• MalfunctionNov 2, 2021Break; Use of Device Problem; Break; Use of Device Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR INITIAL IMPLANT. DURING PROCEDURE THE SCREW ON THE ADAPTOR COULD NOT BE TIGHTENED. THE TORQUE WRENCH WAS UNRESPONSIVE AND THE SCREW FELL WHEN VIEWED FROM THE CROSS SECTION. THE PHYSICIAN SUSPECTED THAT THE SCREW FELL INTO THE LUMEN FROM THE BEGINNING AND WAS BROKEN FROM THE BEGINNING. THE ADAPTOR WAS NOT USED AND WAS REPLACED. THE PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12739357 ↗
• MalfunctionMay 10, 2021Ambient Noise Problem; Ambient Noise Problem

  IT WAS REPORTED PATIENT HAD GENERATOR CHANGED-OUT ON (B)(6) 2021 THAT REQUIRED TWO 6MM LEAD ADAPTORS. NOISE WAS OBSERVED WITH ISOMETRIC EXERCISE TESTING RIGHT VENTRICULAR ((B)(4)) AND RIGHT ATRIAL (UNKNOWN). DEVICE DETECTION OF NOISE APPROPRIATE AND RESPONDING CORRECTLY, ADAPTORS REMAIN IMPLANTED; PHYSICIAN IS MONITORING PATIENT. NO ADVERSE PATIENT EFFECTS WERE REPORTED. REFERENCE 1035166-2021-00042 FOR SERIAL NUMBER (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11801087 ↗
• MalfunctionMay 10, 2021Ambient Noise Problem; Ambient Noise Problem

  IT WAS REPORTED PATIENT HAD GENERATOR CHANGED-OUT ON (B)(6) 2021 THAT REQUIRED TWO 6MM LEAD ADAPTORS. NOISE WAS OBSERVED WITH ISOMETRIC EXERCISE TESTING RIGHT VENTRICULAR (UNIV2711) AND RIGHT ATRIAL (UNKNOWN). DEVICE DETECTION OF NOISE APPROPRIATE AND RESPONDING CORRECTLY, ADAPTORS REMAIN IMPLANTED; PHYSICIAN IS MONITORING PATIENT. NO ADVERSE PATIENT EFFECTS WERE REPORTED. REFERENCE 1035166-2021-00043 FOR UNKNOWN SERIAL NUMBER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11801035 ↗
• MalfunctionApr 25, 2021Connection Problem; Connection Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A ROUTINE DEVICE EXCHANGE. DURING PROCEDURE, THE LEAD COULD NOT BE INSERTED INTO THE CONVERSIONS ADAPTOR. THE ADAPTOR WAS CHANGED AND THE ISSUE WAS RESOLVED. THE PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11721968 ↗
• MalfunctionApr 12, 2021Signal Artifact/Noise; Signal Artifact/Noise

  RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2021-14779. IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A ROUTINE DEVICE EXCHANGE THAT REQUIRED LEAD ADAPTORS. DURING PROCEDURE, NOISE WAS OBSERVED ON THE ATRIAL AND RIGHT VENTRICULAR LEAD. PROGRAMMING CHANGES WERE MADE TO RESOLVE THE ISSUE. THE PATIENT WAS STABLE AND WOULD BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11647046 ↗
• MalfunctionMar 10, 2021Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR INITIAL IMPLANT. DURING PROCEDURE, THE PHYSICIAN NOTICED THAT THE CONNECTOR DID NOT SECURELY CONNECT THE LEAD. THERE WAS NO SUBSTITUTION SO THE CONNECTOR AND LEADS WERE PHYSICALLY SQUEEZED AND PLACED WITH THREADS. THE PHYSICIAN ALLEGES THAT THERE IS A FAULTY SCREW HOLE ON THE CONNECTOR. THERE WERE NO CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11454170 ↗
• MalfunctionMar 10, 2021Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR INITIAL IMPLANT. DURING PROCEDURE, THE PHYSICIAN NOTICED THAT THE CONNECTOR DID NOT SECURELY CONNECT THE LEAD. THERE WAS NO SUBSTITUTION SO THE CONNECTOR AND LEADS WERE PHYSICALLY SQUEEZED AND PLACED WITH THREADS. THE PHYSICIAN ALLEGES THAT THERE IS A FAULTY SCREW HOLE ON THE CONNECTOR. THERE WERE NO CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11454077 ↗