Flexor Parallel G34874Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00827002348745), received between Oct 24, 2016 and Feb 24, 2026 — classified as 1 injury, 20 malfunctions.

The most frequently reported specific device problem is “Peeled/Delaminated” (15 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 24, 2026Peeled/Delaminated

  IT WAS REPORTED, THE ACCESS SHEATH FROM A FLEXOR PARALLEL URETERAL ACCESS SHEATH AND DILATORS FRAYED WHEN THE EXTRACTOR BASKET WAS PASSED THROUGH IT TO CAPTURE AND REMOVE KIDNEY STONES. ADDITIONAL INFORMATION REGARDING THE EVENT HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24429643 ↗
• MalfunctionDec 31, 2025Peeled/Delaminated; Peeled/Delaminated

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23936251 ↗
• MalfunctionAug 22, 2025Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED, A THREAD-LIKE OBJECT, WHICH APPEARED TO BE PEELED COATING, WAS OBSERVED PROTRUDING FROM THE SHEATH OF THE FLEXOR PARALLEL URETERAL ACCESS SHEATH AND DILATORS. THE ISSUE WAS IDENTIFIED AFTER THE ENDOSCOPE WAS INSERTED THROUGH THE ACCESS SHEATH DURING AN UNSPECIFIED PROCEDURE. THE PROCEDURE WAS COMPLETED USING ANOTHER SIMILAR DEVICE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22871050 ↗
• MalfunctionAug 20, 2025Peeled/Delaminated; Peeled/Delaminated

  INFORMATION KNOWN PRIOR TO SENDING THE INITIAL MDR, BUT INADVERTENTLY NOT INCLUDED IN THE INITIAL MDR: A SECOND SHEATH FROM A FLEXOR PARALLEL URETERAL ACCESS SHEATH AND DILATORS WAS USED AND THE DISPOSABLE ENDOSCOPE SCREEN SHOWED SOMETHING THAT LOOKED LIKE PEELING AROUND THE SHEATH TIP. THE PROCEDURE WAS COMPLETED WITH THE SECOND DEVICE. THERE WAS NO MATERIAL THAT NEEDED TO BE REMOVED FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22852335 ↗
• MalfunctionJul 31, 2025Peeled/Delaminated; Peeled/Delaminated

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: Insufficient Information

  MAUDE report 22676336 ↗
• MalfunctionJun 17, 2025Peeled/Delaminated; Peeled/Delaminated

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22238802 ↗
• MalfunctionApr 22, 2025Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED; WHITE FOREIGN MATTER WAS OBSERVED IN THE SHEATH OF A FLEXOR PARALLEL URETERAL ACCESS SHEATH AND DILATOR DURING TRANSURETHRAL URINARY LITHOTRIPSY (TUL). A WIRE GUIDE WAS PLACED IN THE RENAL PELVIS, AND THE SHEATH WAS INSERTED INTO THE URETER. AFTER THE SHEATH'S DILATOR WAS REMOVED AND A DISPOSABLE URETEROSCOPE WAS INSERTED INTO THE SHEATH, MULTIPLE WHITE THREAD-LIKE FOREIGN MATTER WAS OBSERVED IN THE SHEATH VIA THE ENDOSCOPIC IMAGE. THE PROCEDURE WAS COMPLETED BY REMOVING THE FOREIGN MATTER WITH GRASPING FORCEPS. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY OTHER ADDITIONAL INTERVENTION DUE TO THIS OCCURRENCE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21883771 ↗
• MalfunctionMar 31, 2025Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED RESISTANCE WAS FELT DURING INSERTION OF A FLEXOR PARALLEL URETERAL ACCESS SHEATH AND DILATORS¿ SHEATH IN THE COURSE OF A TRANSURETHRAL LITHOTOMY (TUL) PROCEDURE. DURING INSERTING AND REMOVING ANOTHER MANUFACTURER'S ENDOSCOPE (OUTER DIAMETER 8.5 FR) INTO THE SHEATH, RESISTANCE GRADUALLY BEGAN TO BE FELT, AND FIBROUS LIKE FOREIGN MATTER WAS NOTED COMING OUT OF THE SHEATH. NORMALLY, THE SUPPLIED DILATOR WOULD NOT BE INSERTED INTO A SHEATH AT THIS POINT, BUT THERE WAS AN ISSUE WITH THE LUMEN, SO THE PHYSICIAN ATTEMPTED TO INSERT IT TO CHECK IF THE LUMEN WAS OPEN. THE DILATOR COULD NOT BE INSERTED. THE COATING INSIDE THE SHEATH APPEARS TO HAVE PEELED OFF. REPORTEDLY, THIS IS THE FIRST TIME THAT THE ISSUE WAS NOTED. THE PROCEDURE WAS COMPLETED BY USING ANOTHER SAME-LIKE DEVICE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL INTERVENTION DUE TO THIS OCCURRENCE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21731448 ↗
• MalfunctionMar 31, 2025Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED RESISTANCE WAS FELT DURING INSERTION OF A FLEXOR PARALLEL URETERAL ACCESS SHEATH AND DILATORS¿ SHEATH IN THE COURSE OF A TRANSURETHRAL LITHOTOMY (TUL) PROCEDURE. THE PHYSICIAN INSERTED AND REMOVED AN ENDOSCOPE THROUGH THE SHEATH, WHICH WAS PLACED IN THE URETER, FELT RESISTANCE, AND DISCONTINUED ITS USE. THE PROCEDURE WAS COMPLETED BY USING ANOTHER SAME-LIKE DEVICE. A CUSTOMER PROVIDED PICTURE APPEARS TO SHOW THE SHEATH HAD DELAMINATED. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL INTERVENTION DUE TO THIS OCCURRENCE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21730232 ↗
• MalfunctionAug 21, 2023Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT THE COATING ON A FLEXOR PARALLEL URETERAL ACCESS SHEATH AND DILATORS HAD "COME OFF" PRIOR TO USE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION REGARDING THE EVENT HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17591553 ↗
• MalfunctionMar 1, 2023Peeled/Delaminated; Peeled/Delaminated

  AS REPORTED, DURING STONE EXTRACTION, PHYSIOLOGICAL SALINE WAS USED TO ACTIVATE THE SHEATH COATING OF A FLEXOR PARALLEL URETERAL ACCESS SHEATH AND DILATORS. THE DEVICE WAS PLACED AND KIDNEY STONES WERE BROKEN INTO PIECES WITH A LASER. WHILE REMOVING THE STONE FRAGMENTS WITH AN NCIRCLE® NITINOL TIPLESS STONE EXTRACTOR, A WHITISH THREADLIKE FOREIGN SUBSTANCE, BELIEVED TO BE THE LINING OF THE ACCESS SHEATH LUMEN, WHICH MAY HAVE PEELED OFF, WAS OBSERVED UNDER AN ENDOSCOPE. THE SUBSTANCE WAS REMOVED FROM THE PATIENT, WHILE REMOVING THE FRAGMENTS OF THE KIDNEY STONES. IT IS UNKNOWN HOW MANY PASSES THROUGH THE SHEATH WERE MADE BY THE LASER FIBER AND EXTRACTOR. THE PROCEDURE WAS COMPLETED WITHOUT FURTHER PROBLEMS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16459296 ↗
• MalfunctionJul 21, 2022Separation Failure; Separation Failure

  AS REPORTED, DURING A URETEROSCOPY WITH LASER, THE INNER STYLET OF A FLEXOR PARALLEL URETERAL ACCESS SHEATH AND DILATORS SET SPLIT EARLY, AND ANOTHER MANUFACTURER'S WIRE "POPPED OFF". THE DEVICE WAS PLACED VIA RAPID TECHNIQUE AND ADVANCED WITHOUT DIFFICULTY WHEN THE FAILURE OCCURRED. THE RELEASE OF THE WIRE WAS ABRUPT AND OCCURRED BEFORE THE STYLET WAS REMOVED FROM THE SHEATH. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THE OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15073900 ↗
• MalfunctionJun 2, 2022Peeled/Delaminated; Peeled/Delaminated

  AS REPORTED, THE INNER LUMEN OF A FLEXOR PARALLEL URETERAL ACCESS SHEATH DELAMINATED DURING ADVANCEMENT OF A FLEXIBLE URETEROSCOPE THROUGH THE DEVICE. FIBERS FROM THE DELAMINATED SHEATH WERE LEFT IN THE PATIENT. ADDITIONAL INFORMATION REGARDING THE EVENT AND PATIENT OUTCOME HAVE BEEN REQUESTED.

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

  MAUDE report 14578593 ↗
• MalfunctionFeb 11, 2022Peeled/Delaminated; Peeled/Delaminated

  AS REPORTED, DURING A FLEXIBLE URETEROSCOPY, A FLEXOR PARALLEL URETERAL ACCESS SHEATH AND DILATOR'S SHEATH PEELED OFF DURING A KIDNEY STONE EXTRACTION. THE DEVICE WAS PLACED USING THE "TRADITIONAL METHOD" AND WAS IN PLACE BETWEEN 30 AND 60 MINUTES. LATEX GLOVES WERE WORN AND THE COATING WAS ACTIVATED WITH "SERUM PHY/WATER." THE SHEATH WAS REMOVED AND REPLACED WITH ANOTHER DEVICE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ADVERSE EFFECTS DUE TO THIS OCCURRENCE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13515093 ↗
• MalfunctionJan 6, 2022Flaked; Flaked

  AS REPORTED, WHILE USING A FLEXOR PARALLEL URETERAL ACCESS SHEATH AND DILATORS, THEY DISCOVERED FIBER-LIKE MATTER INSIDE OF THE SHEATH LUMEN. THE PROCEDURE WAS TO EXTRACT KIDNEY STONES, AND THE USER HAD INSERTED THE DEVICE INTO THE SCOPE SEVERAL TIMES TO PERFORM THE EXTRACTION. THEY REMOVED IT FROM THE SHEATH LUMEN AND REPLACED IT WITH ANOTHER DEVICE FROM THE SAME LOT. THE FIBER-LIKE MATTER WAS ALSO DISCOVERED IN THIS DEVICE. THEY REPLACED IT WITH A DEVICE FROM ANOTHER MANUFACTURER TO SUCCESSFULLY COMPLETE THE PROCEDURE. THEY CONFIRMED THE FIBER-LIKE MATTER WAS NOT LEFT INSIDE OF THE PATIENT'S BODY. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13175210 ↗
• MalfunctionDec 21, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  ADDITIONAL INFORMATION RECEIVED ON 22DEC2021. THE INFORMATION INCLUDED ALL THE DEVICES THAT WERE INSERTED THROUGH THE LUMEN OF THE SHEATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13051927 ↗
• MalfunctionNov 1, 2021Material Frayed; Material Frayed

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: Insufficient Information

  MAUDE report 12727729 ↗
• MalfunctionJul 7, 2021Peeled/Delaminated; Peeled/Delaminated

  AS REPORTED, A FIBER WAS OBSERVED FLAKING FROM THE INSIDE OF THE SHEATH OF A FLEXOR PARALLEL URETERAL ACCESS SHEATH AND DILATORS SET. THIS WAS NOTED THROUGH A FLEXIBLE SCOPE USED DURING THE PROCEDURE. ADDITIONAL EVENT AND PATIENT OUTCOME INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 12127163 ↗
• MalfunctionMay 20, 2021Peeled/Delaminated; Peeled/Delaminated

  NO NEW PATIENT OR EVENT INFORMATION SINCE THE LAST REPORT WAS SUBMITTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11856934 ↗
• MalfunctionApr 27, 2018Device Operational Issue; Device Damaged by Another Device; Physical Property Issue; Appropriate Device Problem Term/Code Not Available; Device Operational Issue; Device Damaged by Another Device; Physical Property Issue; Appropriate Device Problem Term/Code Not Available

  THE USER FACILITY FILED AN ADVERSE EVENT REPORT WITH THE AUTHORITIES IN GERMANY (FEDERAL INSTITUTE FOR DRUGS AND MEDICAL DEVICES (BFARM)). THE MANUFACTURER WAS PROVIDED THIS REPORT VIA EMAIL CORRESPONDENCE ON (B)(6) 2018: ACCORDING TO THE USER FACILITY REPORT: THIS IS A URETERAL ACCESS SHEATH (FLEXOR PARALLEL RAPIDRELEASE URETERAL ACCESS SHEATH) FOR A FLEXIBLE URETEROSCOPY (URS) FOR DIAGNOSTIC AND OPERATIVE ENDOSCOPY PROCEDURES ON THE URETER AND RENAL PELVICALYCEAL SYSTEMIN UROLOGY. THIS ACCESS SHEATH IS INTRODUCED PARALLEL TO A WIRE GUIDE, WHEREBY A CHUCK SERVES AS A GUIDE. AFTER PLACING THE ACCESS SHEATH, THE CHUCK MUST BE REMOVED BY EFFECTIVELY PULLING IT OUT OF THE WIRE GUIDE. THE CHUCK HAS A SPLIT FOR THIS PURPOSE. COMPARED TO THE SAME PRODUCT FROM OTHER MANUFACTURERS, THIS FEATURE ON THIS PRODUCT APPEARS TO BE DANGEROUSLY VARIABLE (TOO TIGHT/RIGID OR TOO LOOSE/FLEXIBLE). THIS WAS OBSERVED BY VARIOUS EXPERIENCED SURGEONS IN OUR CENTRE 03/18. A DISPLACEMENT OF THE WIRE DURING INTRODUCTION WAS OBSERVED, WHEREBY THE ACCESS SHEATH GOT CAUGHT IN THE PROSTATIC URETHRA OR IN THE BLADDER NEXT TO THE URETERAL OSTIA, CAUSING CLEAR TISSUE DEFECTS (FALSE PASSAGE) WITH HAEMORRHAGE (MACROHA

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 7468545 ↗
• InjuryOct 24, 2016Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE DISTAL TIP END OF A SHEATH HAD DETERIORATED. THUS, LEADING TO 2-3 CM OF THE PATIENT'S URETER BEING INJURED. A STENT WAS PLACED IN THE PATIENT'S URETER IN ORDER TO ASSIST IN THE HEALING PROCESS. THE PATIENT DID NOT EXPERIENCE ANY ADDITIONAL ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: Injury; No Code Available

  MAUDE report 6050467 ↗