Resonance G34112Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10827002341125), received between May 25, 2022 and Jun 5, 2024 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Activation Failure” (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.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 5, 2024Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 09-JAN-2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19467445 ↗
• InjuryJun 16, 2023Difficult to Remove; Use of Device Problem; Difficult to Remove; Use of Device Problem

  SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 12-JAN-2024.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Obstruction/Occlusion

  MAUDE report 17142317 ↗
• InjuryMay 30, 2022Adverse Event Without Identified Device or Use Problem; Activation Failure; Adverse Event Without Identified Device or Use Problem; Activation Failure

  COMPLAINT CALLED IN BY DM ON (B)(6) 2022--DID (B)(6) 2022. AS REPORTED TO CUSTOMER RELATIONS: "STENT WAS IMPLANTED SOMETIME IN MARCH, EXACT DATE UNKNOWN. DOING FOLLOW-UP HYDRONEPHROSIS (DIFFICULTY URINATING) AND PATIENT HAS OTHER STUFF GOING ON, AND THE STENT WAS OBSERVED NOT DRAINING (OR NOT HELPING THE KIDNEY TO DRAIN). DOCTOR SAYS THE PATIENT'S CONDITION IS WORSE THAN PRIOR TO THE IMPLANT. DOCTOR PLANNING ADDITIONAL PROCEDURE FOR TODAY ((B)(6) 2022) TO REMOVE THE STENT." DID ANY UNINTENDED SECTION OF THE DEVICE REMAIN INSIDE THE PATIENT¿S BODY? IF YES, PLEASE DESCRIBE. WAS THE PATIENT HOSPITALIZED OR WAS THERE PROLONGED HOSPITALIZATION DUE TO THIS OCCURRENCE? IF YES, PLEASE DESCRIBE. DID THE PATIENT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE? YES IF YES, PLEASE DESCRIBE. DID THE PRODUCT CAUSE OR CONTRIBUTE TO THE NEED FOR ADDITIONAL PROCEDURES? YES IF YES, PLEASE SPECIFY ADDITIONAL PROCEDURES AND PROVIDE DETAILS. SEE EVENT DESCRIPTION. HAS THE COMPLAINANT REPORTED ANY ADVERSE EFFECTS ON THE PATIENT DUE TO THIS OCCURRENCE? HYDRONEPHROSIS, POSSIBLY OTHER ISSUES. HAS THE COMPLAINANT REPORTED THAT THE PRODUCT CAUSED OR CONTRIBUTED TO THE ADVERSE EFFECTS? YES PLEASE SPE

  Patient problems: Unspecified Kidney or Urinary Problem

  MAUDE report 14540918 ↗
• InjuryMay 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE INITIAL REPORTER: "STENT WAS IMPLANTED SOMETIME IN MARCH, EXACT DATE UNKNOWN. DOING FOLLOW-UP HYDRONEPHROSIS (DIFFICULTY URINATING) AND PATIENT HAS OTHER STUFF GOING ON, AND THE STENT WAS OBSERVED NOT DRAINING (OR NOT HELPING THE KIDNEY TO DRAIN). DOCTOR SAYS THE PATIENT'S CONDITION IS WORSE THAN PRIOR TO THE IMPLANT. DOCTOR PLANNING ADDITIONAL PROCEDURE FOR TODAY ((B)(6) 2022) TO REMOVE THE STENT."

  Patient problems: Unspecified Kidney or Urinary Problem

  MAUDE report 14495693 ↗