ResonanceRecalls & reported problems across all models

We found 4 models of Resonance by Cook Ireland Ltd in the FDA's device registry (GUDID). Together they are named in 97 adverse event reports in the FDA's MAUDE database, received between Jul 11, 2016 and Jun 11, 2026 — classified as 75 injuries, 22 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (13 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Resonance problems

Resonance models

4 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Resonance G34111

  STENT, URETERAL
  38 reports
• Resonance G34110

  STENT, URETERAL
  29 reports
• Resonance G34109

  STENT, URETERAL
  26 reports
• Resonance G34112

  STENT, URETERAL
  4 reports

Recent Resonance adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjuryJun 11, 2026Complete Blockage

  IT WAS REPORTED THAT THE STENT HAD TO BE REMOVED BECAUSE IT WASN¿T DRAINING AND WAS CREATING A BLOCKAGE.

  Patient problems: Insufficient Information

  MAUDE report 25470842 ↗
• MalfunctionJan 7, 2026Material Twisted/Bent; Activation Failure

  CANCELLATION REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 11-FEB-2026. AT WHAT POINT IN THE PROCEDURE DID THE STENT KINK? - DIRECTLY AFTER THE ORIFICE. WHAT TYPE AND SIZE WIRE GUIDE WAS USED WITH THE DEVICE? - UROS-035150-S. PLEASE ADVISE THE ANATOMICAL LOCATION OF THE INTENDED TARGET SITE. - KIDNEY, URETER, BLADDER. WERE ANY OTHER DEFECTS (OTHER THAN THE COMPLAINT ISSUE) OBSERVED ON THE DEVICE PRIOR TO RETURN (E.G., KINK)? - NO. IF ADDITIONAL INTERVENTION WAS PERFORMED, WAS IT DURING THE SAME PROCEDURE AS THE DEVICE FAILURE OR WAS IT SCHEDULED FOR ANOTHER DAY? - SAME DAY, SAME PROCEDURE. WHAT IS THE SCOPE MANUFACTURER AND MODEL NUMBER THAT WAS USED? - WOLF CYSTOSCOPE 21 CH. WAS THE STENT STORED IN STRONG LIGHT E.G., IN A PYRIX MACHINE OR DIRECT SUNLIGHT? - NO, I BROUGHT THE STENT AS REP STOCK. HOW DID THE PHYSICIAN DETERMINE THE LENGTH OF THE STENT TO BE USED FOR THE PROCEDURE? - IT WAS A RESONANCE CHANGE, SO THE SIZE WAS NOT UNKNOWN. BUT UPG WAS NORMAL. WAS RESISTANCE ENCOUNTERED WHEN ADVANCING THE WIRE GUIDE INTO POSITION? - NO. WAS RESISTANCE ENCOUNTERED WHEN ADVANCING THE INTRODUCTION SYSTEM INTO POSITION? - NO. WAS RESISTANCE ENCOUNTERED WHEN ADVANC

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23989454 ↗
• MalfunctionDec 30, 2025Complete Blockage; Complete Blockage

  SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 13-FEB-2026.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23921110 ↗
• MalfunctionNov 25, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  A SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO COMPLETION OF THE INVESTIGATION ON 11 DEC 2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23643035 ↗
• InjuryJan 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED TO CUSTOMER RELATIONS VIA CRI OBSERVATION STUDY COMPLAINT FORM: (B)(6) 2024 SUBJECT DIAGNOSED WITH SEPSIS/UROSEPSIS. ADMITTED TO THE HOSPITAL IN ICU. MEDICAL TREATMENT WITH ANTIBIOTICS AND VASOPRESSORS. SITE RELATED TO RESONANCE METALLIC URETERAL STENT. SITE STATED: ON CT EXAM THE REPORT STATED THAT THE STENT MAY BE MALFUNCTIONING. PER PI HE STATED THAT THIS WAS AN ADVERSE EVENT AND COMPLICATION OF THE STENT. ALSO RELATED THIS TO PRE-EXISTING CONDITION AS THIS RELATES TO THE NATURE OF DISEASE. PATIENT HAS HISTORY OF HORSESHOE KIDNEY AND PAST NEPHRECTOMY. ADMITTED TO HOSPITAL/ICU. VOLUME RESUSCITATION AND VASOPRESSORS GIVEN. COMPLETED STUDY.

  Patient problems: Sepsis

  MAUDE report 21091495 ↗
• InjuryJan 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED TO CUSTOMER RELATIONS VIA CRI OBSERVATION STUDY COMPLAINT FORM: (B)(6)2024 SUBJECT DIAGNOSED WITH SEPSIS/UROSEPSIS. ADMITTED TO THE HOSPITAL IN ICU. MEDICAL TREATMENT WITH ANTIBIOTICS AND VASOPRESSORS. SITE RELATED TO RESONANCE METALLIC URETERAL STENT. SITE STATED: ON CT EXAM THE REPORT STATED THAT THE STENT MAY BE MALFUNCTIONING. PER PI HE STATED THAT THIS WAS AN ADVERSE EVENT AND COMPLICATION OF THE STENT. ALSO RELATED THIS TO PRE-EXISTING CONDITION AS THIS RELATES TO THE NATURE OF DISEASE. PATIENT HAS HISTORY OF HORSESHOE KIDNEY AND PAST NEPHRECTOMY.

  Patient problems: Sepsis

  MAUDE report 21079375 ↗
• InjurySep 20, 2024Difficult to Remove; Difficult to Remove

  SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 08-AUG-2025. ADDITIONAL INFORMATION RECEIVED ON 07-OCT-2024. 1. WHAT WAS THE LENGTH OF THE INDWELL TIME? 1 YEAR. 2. WHAT WAS USED TO REMOVE THE STENT? LASER, GRASPERS. 3. WAS ENCRUSTATION EVIDENT ON THE STENT? YES. 4. DID THE PATIENT REQUIRE ANY ADDITIONAL PROCEDURES AS A RESULT OF THIS EVENT? YES. INITIAL PROCEDURE ON (B)(6) 2024, ADDITIONAL PROCEDURES ON (B)(6) 2024. 5. WHAT INTERVENTION (IF ANY) WAS REQUIRED? ADDITIONAL PROCEDURES: (B)(6) 2024 BILATERAL RETROGRADE PYELOGRAM, INSERTION OF LEFT URETERAL STENT, ATTEMPTED REMOVAL OF LEFT URETERAL STENT, EXTRACORPORAL SHOCKWAVE LITHOTRIPSY LEFT RENAL STONE AND DISTAL LEFT URETERAL STONE. (B)(6) 2024 HOLMIUM LASER LITHOTRIPSY OF BLADDER STONE ON STENT, LEFT PERCUTANEOUS NEPHROSTOURETEROLITHOTOMY, ANTEGRADE URETEROSCOPY WITH LASER LITHOTRIPSY OF URETER STONE, EXCHANGE LEFT URETERAL STENT. 6. WAS THE SECONDARY INTERVENTION PERFORMED DURING THE SAME PROCEDURE AS THE DEVICE FAILURE OR WAS IT SCHEDULED FOR ANOTHER DAY? ANOTHER DAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20264940 ↗
• InjurySep 17, 2024Difficult to Remove; Difficult to Remove

  PER THE DOCTOR'S POST-OP NOTE: TRANSURETHRAL: "THE BLADDER WAS EXAMINED. THE INDWELLING COOK RESONANCE STENT WAS SEEN TO HAVE A SMALL AMOUNT OF STONE DEBRIS ATTACHED TO IT FOR DISTANCE OF APPROXIMATELY 2 CM." PERCUTANEOUS: "THE FLEXIBLE NEPHROSCOPE WAS PASSED DOWN TO THE PROXIMAL END OF THE COOK RESONANCE STENT WHICH WAS PRESENT IN THE PROXIMAL URETER. NO SIGNIFICANT DEBRIS WAS PRESENT UPON THIS. MULTIPLE ATTEMPTS WERE MADE WITH MULTIPLE DEVICES TO ENGAGE THE STENT AND REMOVE IT, BUT THESE WERE NOT SUCCESSFUL. DURING THESE ATTEMPTS THE ACCESS SHEATH DID PULL BACK OUT OF THE KIDNEY AND ACCESS WAS REESTABLISHED BY THE PHYSICIAN AND THE INTERVENTIONAL RADIOLOGY TEAM. THE FLEXIBLE URETEROSCOPE WAS THEN PASSED INTO THE RENAL PELVIS AND DOWN THE LEFT URETER ALONGSIDE THE COIL IN THE RESIDENT STENT WHICH WAS PRESENT IN THE UPPER URETER. THIS WAS PASSED DISTALLY WHERE A 8 MM STONE WAS ENCOUNTERED IN THE MID URETER ATTACHED TO THE STENT. " UPDATED (B)(6) 2024: SURGERY DATES: (B)(6) 2024: CYSTOSCOPY, LEFT RETROGRADE PYELOGRAM, LEFT URETEROSCOPY, ATTEMPTED REMOVAL OF LEFT URETERAL STENT UNSUCCESSFUL. (B)(6) 2024: CYSTOSCOPY, BILATERAL RETROGRADE PYELOGRAM, INSERTION OF LEFT URETERAL STENT, AT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20236450 ↗
• InjuryJul 30, 2024Complete Blockage; Complete Blockage

  SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 05-NOV-2024.

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

  MAUDE report 19859878 ↗
• InjuryJul 12, 2024Fracture; Fracture

  ON (B)(6) 2024, PATIENT WAS UNDER RMS STENT REPLACEMENT PROCEDURE, USER DETECTED THERE WAS DIFFICULTY REMOVING THE STENT AND THE STENT INNER WIRE BROKEN. NO HARM TO PATIENT. UPDATED ON (B)(6) 2024 TP: AFTER PATIENT COMMUNICATION, THERE IS CONCERNS OF THE RISK SO THAT THE STENT IS STILL REMAINS IN PATIENT. NO HARM TO PATIENT.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19728604 ↗
• MalfunctionJun 13, 2024Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  DESCRIPTION OF EVENT: A 22 CM RESONANCE STENT WAS ATTEMPTED TO BE PLACED AND DURING PLACEMENT A GUIDEWIRE BECAME "JAMMED" IN THE STENT AND THE STENT COULDN'T BE PLACED. THE STENT AND GUIDEWIRE WERE DISCARDED. NO DAMAGE TO THE PATIENT WAS NOTED. ANOTHER 22CM RESONANCE STENT (LOT NUMBER C2114313) WAS OPENED AND PLACED WITHOUT ISSUE. ALSO A 24 CM RESONANCE STENT (RMS-060024-R LOT NUMBER C2134946) WAS PLACED ON THE OTHER SIDE AND WAS PLACED WITHOUT ISSUE. PATIENT/EVENT INFO - NOTES: THE CUSTOMER HAS INDICATED THAT THEY ARE UNABLE TO PROVIDE MUCH MORE INFORMATION. ALL THEY ARE ABLE TO SHARE IS THAT THE WIRE GUIDE WAS NOT INSERTED INTO THE STENT WITH THE RMS 24CM. IT WAS PLACED WITHOUT ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19526358 ↗
• 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 ↗
• MalfunctionMar 7, 2024Off-Label Use; Improper or Incorrect Procedure or Method; Off-Label Use; Improper or Incorrect Procedure or Method

  AFTER ADVANCING A 0.035-INCH WIRE GUIDE INTO THE RENAL PELVIS, THE TIP OF THE URETERAL CATHETER WAS ADVANCED INTO THE RENAL PELVIS FOR CONTRAST IMAGING. AFTER REMOVING THE URETERAL CATHETER, IT WAS REPLACED WITH THE PROVIDED SHEATH AND ADVANCED INTO THE URETER. THE STENOSIS OF UPF (URETEROPELVIC JUNCTION) WAS SEVERE AND THE SHEATH COULD NOT PASS THROUGH, SO ITS USE WAS DISCONTINUED AND INSTEAD A DJ URETERAL STENT (BD/INLAY OPTIMA STENT SET 6FR 26CM) WAS PLACED TO COMPLETE THE PROCEDURE. NO ADVERSE EFFECT ON THE PATIENT HAS BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18854095 ↗
• InjuryFeb 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO COMPLETION OF THE INVESTIGATION ON 31 JUL 2024.

  Patient problems: Unspecified Kidney or Urinary Problem; Urinary Tract Infection

  MAUDE report 18667395 ↗
• InjuryFeb 8, 2024Migration; Migration

  AS REPORTED TO CUSTOMER RELATIONS VIA CIR COMPLAINT FORM "AS REPORTED TO CUSTOMER RELATIONS VIA CIR COMPLAINT FORM "ON 13JAN2020 THE DEVICE WAS PLACED DUE TO CHRONIC HYDRONEPHROSIS VIA CYSTOSCOPY WITH RETROGRADE PYELOGRAM. PLACEMENT WAS CONFIRMED VIA FLUOROSCOPY. DEVICE WAS REMOVED EMERGENTLY ON (B)(6) 2020 DUE TO COMPLICATION OF STENT DISLODGEMENT AND ENCRUSTATION AND WAS A DEVICE DEFICIENCY. SITE STATED ¿EMERGENT PROCEDURE FOR DISLODGEMENT AND HEAVILY CALCIFIED METAL STENT. THICK, PURULENT EFFLUVIUM RELEASED AFTER NEW STENT PLACED." (B)(4) CAPTURES THE ENCRUSTATION AND THIS COMPLAINT CAPTURES THE STENT DISLODGEMENT PATIENT OUTCOME: THERE IS DATA IS STILL PENDING WITH MULTIPLE QUERIES. SITE STATES THERE WERE ADVERSE EVENTS INVOLVING THE STUDY DEVICE BUT HAS NOT ENTERED THE ADVERSE EVENT DATA. PATIENT/EVENT INFO - NOTES: NO MANUFACTURE ADDITIONAL QUESTIONS WERE ASKED AS THIS IS A CRI PMCF STUDY COMPLAINT. -(B)(4) 09JAN2024.

  Patient problems: Obstruction/Occlusion; Urinary Tract Infection

  MAUDE report 18666717 ↗

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