Resonance G34111Recalls & reported problems

Summary

The FDA's MAUDE database contains 38 adverse event reports that list this exact device (DI 10827002341118), received between Jul 11, 2016 and Jun 11, 2026 — classified as 29 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Obstruction of Flow” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 38 reports, 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 ↗
• 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 ↗
• 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 ↗
• 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, 2024Migration; Migration

  A SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO COMPLETION OF THE INVESTIGATION ON 14-AUG-2024.

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

  MAUDE report 18666219 ↗
• InjuryJan 30, 2024Migration; Migration

  THE PHYSICIAN INSTALLED A RESONANCE DOUBLE J 6 X 26 ON A PATIENT ON (B)(6) 2023. TODAY JAN 10, THE PHYSICIAN COMMUNICATED THAT THE INSTALLED DOUBLE J HAS MOVED HENCE MIGRATED TO THE PROXIMAL URETER OF THE PATIENT WHICH LEADS TO A SECOND PROCEDURE FOR REPLACEMENT. ADDITIONAL INFORMATION PROVIDED CONFIRMED THE STENT MIGRATED UP THE URETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18608182 ↗
• InjuryJun 29, 2023Migration; Material Too Soft/Flexible; Migration; Material Too Soft/Flexible

  SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 10-JAN-2024.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17223490 ↗
• InjuryAug 4, 2022Migration; Migration

  STENT MOVED INTO BLADDER. "AS PER CC FORM": INSERTION OF THE STENT WAS PROBLEM - FREE ON (B)(6) 2022, ON (B)(6) THE PATIENT REPORTED KIDNEY PAIN. THE ULTRASOUND SHOWED THAT THE STENT IS NOT PLACE CORRECTLY. IN ADDITION THE KIDNEY WAS THIRD - DEGREE CONGESTED. LAB COMPLETE (B)(6) 2022: VISUAL INSPECTION STENT RETURNED. SLIGHT ENCRUSTATION OBSERVED ON ONE OF THE PIGTAIL CURLS. PIGTAIL CURL ON THE OTHER END OF THE STENT SLIGHTLY RAISED. NO OTHER DEFECTS OBSERVED. FUNCTIONAL INSPECTION N/A. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. NEW STENT INSERTION. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. 1. ARE ANY IMAGES AVAILABLE FOR REVIEW? N/A, YES, NO. 2. WHAT WAS THE TARGET LOCATION FOR THE STENT? ONE PIGTAIL IN THE KIDNEY AND THE OTHER IN THE BLADDER. 3. DID ANYTHING HAVE TO BE REMOVED FROM THE PATIENT? N/A, YES, NO. 4. IF YES, PLEASE SPECIFY: RESONANCE STENT. (I) WHAT PART OF THE BODY THE DEVICE WAS REMOVED FROM? BLADDER. (II) WHAT DEVICE WAS REMOVED? RESONANCE STENT. (III) WHAT INSTRUMENT WAS USED TO REMOVE IT? CYSTOSCOPE. 5

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions; Unspecified Kidney or Urinary Problem

  MAUDE report 15163947 ↗
• InjuryJul 22, 2021Off-Label Use; Patient Device Interaction Problem; Off-Label Use; Patient Device Interaction Problem

  AFTER STENT WAS IMPLANTED THE URETER IS GROWING TOGETHER WITH THE ILIACAL VESSELS, THE SURGEON REPORTED. GOOGLE TRANSLATION: HELLO EVERYBODY. I WOULD LIKE TO REGISTER A COMPLAINT: (B)(4) HOSPITAL. G-NO: (B)(4). RPN: RMS-060026-R. LOT: C1802783. INTERVENTION: (B)(6) 2021. INCIDENT: COMPLAINTS IN THE LAST WEEK ((B)(6) 2021) AND SURGICALLY REMOVED ON (B)(6) 2021). REPORTED TO (B)(4) BY (B)(4) ON 06/24/21. AFTER THE RESONANCE METALLIC STENT HAS BEEN INSERTED, THERE MUST BE AN EFFECT OF THE URETER GROWING TOGETHER WITH THE ILLIACAL VESSELS (ACCORDING TO THE SURGEON) - THE HOSPITAL WILL ISSUE A PRECISE DESCRIPTION AND I WILL FORWARD IT AS SOON AS I RECEIVE IT.

  Patient problems: Fistula; Urethral Stenosis/Stricture

  MAUDE report 12210225 ↗
• InjuryJun 16, 2020Difficult to Remove; Use of Device Problem; Difficult to Remove; Use of Device Problem

  ADDITIONAL INFORMATION RECEIVED AS FOLLOWS ON 23-JUNE-2020. PER PHYSICIAN FILLING OUT REMAINDER OF COMPLAINT FORM: HAD SAFETY WIRE IN PLACE. ATTEMPTED TO REMOVE STENT WITH FLEXIBLE GRASPER BUT WAS NOT UNABLE TO UNCOIL DISTAL PIGTAIL. PULLED WITH A DECENT AMOUNT OF FORCE SEVERAL TIMES BUT WASN'T ABLE TO UNCURL WITH THE RESISTANCE SHE WAS APPLYING. SHE WORRIED SHE WOULD AVULSE THE URETER BY PULLING TOO HARD. MADE THE DECISION TO MIX SALINE WITH VISCOUS LIDOCAINE JELLY AND INJECT UP THE URETER THROUGH A URETERAL CATHETER. SHE THEN PULLED WITH MORE FORCE AND WAS ABLE TO EXTRACT THE DEVICE. ULTIMATELY, THE DEVICE CAME OUT FINE AND IN ONE PIECE BUT WAS SLIGHTLY CURLED ON THE DISTAL END. SHE DETERMINED THAT THE RESISTANCE WAS THAT THE PIGTAIL JUST WOULDN'T UNCURL. AFTER THE DEVICE WAS REMOVED FROM THE PATIENT, SHE WAS ABLE TO UNCURL THE PIGTAIL WITH HER FINGERS. SHOT RETROGRADE AND THERE WAS NO EXTRAVASATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10157019 ↗
• InjuryMay 26, 2020Complete Blockage; Complete Blockage

  AS REPORTED TO CUSTOMER RELATIONS: "STENT PLACED IN (B)(6) 2019 AFTER 4 MONTHS CT PERFORMED AND NO HYDRONEPHROSIS, SO IT LOOKS AS IF THE STENT IS DRAINING. AT 5 MONTHS PATIENT BECAME SYMPTOMATIC AND CONTINUES TO BE WITH "GROSS HEMATURIA, URGENCY AND URGE INCONTINENCE." CYSTOSCOPY PERFORMED AND DISTAL PORTION OF STENT WAS ENCRUSTED AND BLADDER IS INFLAMED." ADDITIONAL INFORMATION PROVIDED BY DM ON 29APR2020: "CAN YOU INDICATE THE DATE ON WHICH THE CUSTOMER DISCOVERED THIS ISSUE? ACCORDING TO DR. (B)(6) THE PATIENT BECAME SYMPTOMATIC APPROXIMATELY ONE MONTH AGO." STENT WILL BE REMOVED AND REPLACED WITH A PLASTIC STENT ON (B)(6).

  Patient problems: Hematuria; Incontinence; Inflammation

  MAUDE report 10086200 ↗
• InjuryMay 6, 2020Biofilm coating in Device; Biofilm coating in Device

  ACCORDING TO THE INITIAL REPORTER: "STENT PLACED IN (B)(6) 2019 AFTER 4 MONTHS CT PERFORMED AND NO HYDRONEPHROSIS, SO IT LOOKS AS IF THE STENT IS DRAINING. AT 5 MONTHS PATIENT BECAME SYMPTOMATIC AND CONTINUES TO BE WITH "GROSS HEMATURIA, URGENCY AND URGE INCONTINENCE." CYSTOSCOPY PERFORMED AND DISTAL PORTION OF STENT WAS ENCRUSTED AND BLADDER IS INFLAMED".

  Patient problems: Swelling

  MAUDE report 10029991 ↗
• InjuryMar 4, 2020Difficult to Remove; Difficult to Remove

  ACCORDING TO THE INITIAL REPORTER, THE PHYSICIAN ATTEMPTED A BI-LATERAL RMS STENT EXCHANGE BUT WAS UNABLE TO REMOVE EITHER STENT. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS HELD A PCNL WAS PERFORMED TO REMOVE THE RESONANCE METALLIC STENTS (G34111) THAT WERE UNABLE TO BE RETRIEVED DURING THE BI-LATERAL STENT EXCHANGE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9786176 ↗
• InjuryMar 3, 2020Difficult to Remove; Difficult to Remove

  PER REP - (B)(6) 2020 - I NEED TO REPORT AN INCIDENT ON BEHALF OF (B)(6) MD. HE ATTEMPTED A BI-LATERAL RMS STENT EXCHANGE BUT WAS UNABLE TO REMOVE EITHER STENT. BOTH STENTS HAVE BEEN SENT TO PATHOLOGY BUT WILL BE RETURNED TO MATERIAL MANAGEMENT TO THEN BE RETURNED TO COOK FOR INVESTIGATION. PER REP - (B)(6) 2020 - THE PROCEDURE WAS HELD AT (B)(6) MEDICAL CENTER HILLCREST (C12016-3). A PCNL WAS PERFORMED TO REMOVE THE RESONANCE METALLIC STENTS (G34111) THAT WERE UNABLE TO BE RETRIEVED DURING THE BI-LATERAL STENT EXCHANGE. LOT NUMBERS: C1484934 (LEFT URETER) AND C1477851 (RIGHT URETER). PER COMPLAINT FORM - (B)(6) 2020 - ATTEMPTED RIGID CYSTOSCOPE WITH FLEXIBLE GRASPER REMOVAL. THE REP HAS BEEN ASKED TO PROVIDE INTERVENTION AND PATIENT OUTCOME INFORMATION. -MS (B)(6) 2020 1. DID ANY UNINTENDED SECTION OF THE DEVICE REMAIN INSIDE THE PATIENT¿S BODY? -YES IF YES, PLEASE DESCRIBE. -FAILED EXCHANGE ON (B)(6) 2020 / EXPLANTED ON 04FEB2020 2. DID THE PATIENT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE? -YES IF YES, PLEASE DESCRIBE. -BILATERAL PERCUTANEOUS RENAL DILATION W/ STENT REMOVAL (B)(6) 2020. 3. DID THE PRODUCT CAUSE OR CONTRIBUTE TO THE NEED FOR ADDITIONAL PROCEDURES?

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9780295 ↗
• InjuryMar 3, 2020Difficult to Remove; Difficult to Remove

  PER REP - 04EB2020 - I NEED TO REPORT AN INCIDENT ON BEHALF OF (B)(6), MD. HE ATTEMPTED A BI-LATERAL RMS STENT EXCHANGE BUT WAS UNABLE TO REMOVE EITHER STENT. BOTH STENTS HAVE BEEN SENT TO PATHOLOGY BUT WILL BE RETURNED TO MATERIAL MANAGEMENT TO THEN BE RETURNED TO COOK FOR INVESTIGATION. PER REP - 05FEB2020 - THE PROCEDURE WAS HELD AT (B)(6) MEDICAL CENTER (B)(6). A PCNL WAS PERFORMED TO REMOVE THE RESONANCE METALLIC STENTS (G34111) THAT WERE UNABLE TO BE RETRIEVED DURING THE BI-LATERAL STENT EXCHANGE. LOT NUMBERS: C1484934 (LEFT URETER) AND C1477851 (RIGHT URETER). PER COMPLAINT FORM - 13FEB2020 - ATTEMPTED RIGID CYSTOSCOPE WITH FLEXIBLE GRASPER REMOVAL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9780291 ↗
• InjuryMar 2, 2020Fracture; Fracture

  COMPLAINT CALLED IN BY DM ON 04FEB2020--DID 04FEB2020. AS REPORTED TO CUSTOMER RELATIONS: "CUSTOMER SAID THAT, UPON RETRIEVAL, THE STENT BROKE. NO OTHER DETAILS PROVIDED AT THIS TIME." ADDITIONAL INFORMATION PROVIDED BY DM ON 04FEB2020: " HOW WAS THE PROCEDURE COMPLETED? BY PULLING ON STENT IT FINALLY CAME LOOSE."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9774231 ↗
• InjuryMar 2, 2020Material Separation; Material Separation

  ACCORDING TO THE INITIAL REPORTER "UPON RETRIEVAL, THE STENT BROKE." IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED BY PULLING ON STENT UNTIL IT FINALLY CAME LOOSE.

  Patient problems: No Information

  MAUDE report 9774060 ↗
• InjuryFeb 27, 2020Difficult to Remove; Difficult to Remove

  ACCORDING TO THE INITIAL REPORTER, THE PHYSICIAN ATTEMPTED A BI-LATERAL STENT EXCHANGE HOWEVER WAS UNABLE TO RETRIEVE THE STENTS. IT WAS LATER REPORTED DURING THE PCNL (PERCUTANEOUS NEPHROLITHOTOMY), A RIGID CYSTOSCOPE WITH FLEXIBLE GRASPER WERE USED.

  Patient problems: No Code Available

  MAUDE report 9764548 ↗
• InjuryFeb 12, 2020No Flow; No Flow

  AS INITIALLY REPORTED TO CUSTOMER RELATIONS VIA EMAIL FROM CUSTOMER TO DISTRICT MANAGER: THE METAL STANDS WE RECENTLY PLACED ARE NOT DRAINING. SHE IS BACK ON NEPHROSTOMY DRAINAGE.

  Patient problems: Failure of Implant

  MAUDE report 9701564 ↗
• InjuryJan 20, 2020Complete Blockage; No Flow; Complete Blockage; No Flow

  AS INITIALLY REPORTED TO CUSTOMER RELATIONS VIA EMAIL FROM CUSTOMER TO DISTRICT MANAGER: THE METAL STANDS WE RECENTLY PLACED ARE NOT DRAINING. SHE IS BACK ON NEPHROSTOMY DRAINAGE. DID ANY UNINTENDED SECTION OF THE DEVICE REMAIN INSIDE THE PATIENT¿S BODY? NO IF YES, PLEASE DESCRIBE. 2. DID THE PATIENT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE? N/A IF YES, PLEASE DESCRIBE. 3. DID THE PRODUCT CAUSE OR CONTRIBUTE TO THE NEED FOR ADDITIONAL PROCEDURES? N/A IF YES, PLEASE SPECIFY ADDITIONAL PROCEDURES AND PROVIDE DETAILS. 4. HAS THE COMPLAINANT REPORTED ANY ADVERSE EFFECTS ON THE PATIENT DUE TO THIS OCCURRENCE? N/A. 5. HAS THE COMPLAINANT REPORTED THAT THE PRODUCT CAUSED OR CONTRIBUTED TO THE ADVERSE EFFECTS? NA. PLEASE SPECIFY ADVERSE EFFECTS AND PROVIDE DETAILS.

  Patient problems: Failure of Implant

  MAUDE report 9606903 ↗
• MalfunctionSep 9, 2019Use of Device Problem; Activation, Positioning or Separation Problem; Use of Device Problem; Activation, Positioning or Separation Problem

  AS REPORTED TO CUSTOMER RELATIONS, "THE STENT GOT STUCK IN THE CLEAR SHEATH. THEY PHYSICIAN NOTICED A KINK IN THE CLEAR SHEATH. PHYSICIAN INDICATED THIS COULD HAVE BEEN FROM A STRICTURE OR USER ERROR ON THEIR PART. A SECOND STENT (LOT#: C1601025) WAS OPENED, AND SHE AGAIN HAD A DIFFICULT TIME GETTING THE STENT THRU THE CLEAR SHEATH. BOTH STENT WERE ULTIMATELY PLACED." NOTE: THE PHYSICIAN CUT THE CLEAR OUTER SHEATH DUE TO THE METALLIC STENT BEING STUCK. THE PHYSICIAN DID NOT WANT TO LOSE ACCESS AND SHE NEEDED TO GET A WIRE IN.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 8974128 ↗
• MalfunctionSep 9, 2019Use of Device Problem; Activation, Positioning or Separation Problem; Use of Device Problem; Activation, Positioning or Separation Problem

  AS REPORTED TO CUSTOMER RELATIONS, "THE STENT GOT STUCK IN THE CLEAR SHEATH. THEY PHYSICIAN NOTICED A KINK IN THE CLEAR SHEATH. PHYSICIAN INDICATED THIS COULD HAVE BEEN FROM A STRICTURE OR USER ERROR ON THEIR PART. A SECOND STENT (LOT#: C1601025) WAS OPENED, AND SHE AGAIN HAD A DIFFICULT TIME GETTING THE STENT THRU THE CLEAR SHEATH. BOTH STENT WERE ULTIMATELY PLACED." NOTE: THE PHYSICIAN CUT THE CLEAR OUTER SHEATH DUE TO THE METALLIC STENT BEING STUCK. THE PHYSICIAN DID NOT WANT TO LOSE ACCESS AND SHE NEEDED TO GET A WIRE IN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8974112 ↗
• InjurySep 6, 2019Obstruction of Flow; Obstruction of Flow

  BOTH THE STENTS GOT BLOCKED AND PATIENT DEVELOPED ACUTE RENAL FAILURE.

  Patient problems: Renal Failure

  MAUDE report 8968509 ↗
• InjurySep 6, 2019Obstruction of Flow; Obstruction of Flow

  BOTH THE STENTS GOT BLOCKED AND PATIENT DEVELOPED ACUTE RENAL FAILURE. FDA MDR REPORTING REQUIRED: THIS EVENT MEETS THE CRITERIA OF AN FDA ¿SERIOUS INJURY¿ REPORT AS PER FDA GUIDELINES ¿MEDICAL DEVICE REPORTING FOR MANUFACTURERS (2016)¿ SECTION 2.13 AND 2.15 AS BOTH THE STENTS GOT BLOCKED AND PATIENT DEVELOPED ACUTE RENAL FAILURE AND BASED ON THE ASSUMPTION THAT INTERVENTION WOULD BE REQUIED TO REMOVE THE DEVICES, ALSO REPORTABLE BASED ON THE DEVICE MALFUNCTION REPORTING PRECEDENCE FOR THIS DEVICE FAMILY FOR THE ISSUE OF ¿STENT DOES NOT DRAIN'.

  Patient problems: Renal Failure

  MAUDE report 8968503 ↗
• InjuryAug 19, 2019No Flow; No Flow

  PATIENT WAS IMPLANTED COOK STENT SUCCESSFULLY ON (B)(6) 2019 IN LEFT URETER. THERE IS NO BLEEDING DETECTED AND THE URINE IS NORMAL AFTER IMPLANTATION. SECOND DAY AFTER PROCEDURE PATIENT HAS NO URINE AND INCREASED CREATININE. USER CONDUCTED NEPHROSTOMY AT LEFT URETER, AND NEPHROSTOMY TUBE DRAINAGE WELL. THE URINE BECAME NORMAL AND CREATININE DECREASED AFTER NEPHROSTOMY. IN THE FOLLOWING 3 DAYS USER TRIED SEVERAL TIMES TO CLAMP THE NEPHROSTOMY TUBE TO SEE IF THE STENT IS UNOBSTRUCTED, BUT NO URINE COMES OUT. USER IMPLANTED ANOTHER SAME STENT TO REPLACE THE ONE IMPLANTED LAST TIME 2 WEEKS AFTER. THERE WAS NO BLEEDING DETECTED AND URINE IS NORMAL, AND THE NEPHROSTOMY TUBE WAS REMOVED AS WELL. URINE IS NORMAL EACH AFTER THE PROCEDURE. FDA MDR REPORTING REQUIRED: THIS EVENT MEETS THE CRITERIA OF AN FDA ¿SERIOUS INJURY¿ REPORT AS PER FDA GUIDELINES ¿MEDICAL DEVICE REPORTING FOR MANUFACTURERS (2016)¿ SECTION 2.13 AND 2.15 AS THE PATIENT HAD NEPHROSTOMY TUBE PLACE AFTER STENT STOPPED DRAINING AND SURGICAL INTERVENTION WAS REQUIRED TO REMOVE THE NON-FUNCTIONING STENT, ALSO REPORTABLE BASED ON THE DEVICE MALFUNCTION REPORTING PRECEDENCE FOR THIS DEVICE FAMILY FOR THE ISSUE OF ¿STENT DOES NOT

  Patient problems: Failure of Implant

  MAUDE report 8906981 ↗