Flexor Parallel G56436Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00827002564367), received between Oct 20, 2017 and Dec 3, 2024 — classified as 2 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Difficult to Advance” (2 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 3, 2024Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED, THE FLEXOR PARALLEL URETERAL ACCESS SHEATH AND DILATORS' PACKAGE WAS NOT SEALED PROPERLY AND THE DEVICE "FELL OUT". THE ISSUE WAS DISCOVERED WHILE THE DEVICE WAS IN THE WAREHOUSE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20836075 ↗
• MalfunctionApr 17, 2023Peeled/Delaminated; Difficult to Advance; Peeled/Delaminated; Difficult to Advance

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

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

  MAUDE report 16753463 ↗
• MalfunctionJul 8, 2022Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  AS REPORTED, PRIOR TO THE START OF A URETEROSCOPY, A HAIR WAS DISCOVERED INSIDE THE STERILE PACKAGING OF A FLEXOR PARALLEL URETERAL ACCESS SHEATH AND DILATORS. ANOTHER SAME TYPE DEVICE WAS USED TO COMPLETE THE PROCEDURE. 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 14955872 ↗
• MalfunctionDec 16, 2021Flaked; Flaked

  AS REPORTED, DURING A URETEROSCOPY (URS), THE FLEXOR PARALLEL URETERAL ACCESS SHEATH AND DILATORS BEGAN TO DETERIORATE, IN THE PATIENT, DURING THE PROCEDURE. THE DEVICE WAS RETURNED 03-DEC-2021 AND IT WAS DISCOVERED THAT THE INNER LINING OF THE SHEATH HAS DELAMINATED. NO SECTION OF THE DEVICE REMAINED 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 13017341 ↗
• MalfunctionJun 7, 2021Difficult to Advance; Difficult to Advance

  THERE IS NO NEW PATIENT OR EVENT INFORMATION TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11952322 ↗
• MalfunctionJan 19, 2021Unsealed Device Packaging; Unsealed Device Packaging

  AS REPORTED, UPON DELIVERY OF A FLEXOR PARALLEL URETERAL ACCESS SHEATH AND DILATORS, IT WAS DISCOVERED THAT THE PACKAGE WAS OPEN DUE TO A MISSING SEAL. THE ISSUE WAS DISCOVERED IN THE PURCHASING DEPARTMENT AND THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 11196062 ↗
• MalfunctionJun 22, 2020Physical Resistance/Sticking; Physical Resistance/Sticking

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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10179667 ↗
• MalfunctionOct 29, 2019Device Handling Problem; Device Handling Problem

  ADDITIONAL INFORMATION WAS RECEIVED (B)(6) 2019: IT WAS REPORTED, THERE WAS NO MAJOR BLEEDING AND NO ADDITIONAL SURGICAL INTERVENTION WAS NEEDED. THEY PLACED A FOLEY CATHETER AND POSTPONED THE PROCEDURE. RECEIVED CLARIFICATION ON (B)(6) 2019: THE STONE REMOVAL PROCEDURE WAS POSTPONED, THE DATE IT WAS POSTPONED TO IS UNKNOWN. THE LOT NUMBER IS UNKNOWN. THE DEVICE PACKAGING AND THE DEVICE WERE DISCARDED BY THE CUSTOMER. THE LOT NUMBER PREVIOUSLY REPORTED IS THE LOT NUMBER OF AN UNOPENED DEVICE FROM THE CUSTOMERS STOCK THAT IS BEING RETURNED. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2019:THE STONE REMOVAL PROCEDURE WAS NOT POSTPONED. THEY WERE ABLE TO COMPLETE THE PROCEDURE AFTER REINTRODUCING THE URETERAL ACCESS SHEATH WITHOUT ANY COMPLICATIONS. BECAUSE OF THE PERFORATION OF THE URETHRA THEY DECIDED TO LEAVE THE FOLEY CATHETER IN PLACE ONE DAY LONGER AFTER THE COMPLETION OF THE PROCEDURE. THERE WAS NO MAJOR BLEEDING AND NO ADDITIONAL INTERVENTION TO REPAIR THE URETHRA WAS NEEDED. ADDITIONAL INFORMATION WAS RECEIVED (B)(6) 2019:THE PATIENT HAD NORMAL ANATOMY. THE GUIDE WIRE WAS INSERTED INTO THE ROUND OPENING AT THE DISTAL TIP OF THE DILATOR.

  Patient problems: Internal Organ Perforation

  MAUDE report 9251795 ↗
• MalfunctionApr 25, 2019Device Slipped; Device Slipped

  NO NEW EVENT INFORMATION HAS BEEN PROVIDED/RECEIVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8552209 ↗
• MalfunctionAug 27, 2018Peeled/Delaminated; Peeled/Delaminated

  THERE HAS BEEN NO NEW INFORMATION RECEIVED SINCE THE LAST REPORT WAS SUBMITTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7819001 ↗
• InjuryJul 5, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A MALE PATIENT UNDERWENT A FLEXIBLE URETEROSCOPY PROCEDURE BECAUSE OF NEPHROLITHIASIS LEFT. AFTER A RETROGRADE PYELOGRAPHY THE URETER WAS NORMAL. THERE WAS NO STENT PLACED BEFORE THOUGH. AFTER PUTTING IN THE GUIDE WIRE THE DOCTOR PLACED THE FLEXOR PARALLEL URETERAL ACCESS SHEATH 12 FRENCH WITHOUT FEELING ANY RESISTANCE AND THE SHEATH WAS NOT DISCONNECTED. THE DOCTOR WENT IN WITH THE FLEXIBLE URETEROSCOPE AFTER TAKING OUT THE GUIDE WIRE AND SAW A NORMAL PROXIMAL URETER. AS REPORTED, JUST ON THE DISTAL EDGE OF THE SHEATH THE DOCTOR SAW SOME FATTY TISSUE. HE MOVED BACK AND SAW A MAJOR LESION ON THE LATERAL URETER WALL OF A LENGTH OF ABOUT 3CM. THE DOCTOR WAS SHOCKED BECAUSE HE WASN'T EXPECTING THIS. IT IS NOT KNOWN IF THE PATIENT UNDERWENT ANY PROCEDURES BEFOREHAND, LIKE A URETERAL STONE REMOVAL OR MAYBE RADIATION WHICH COULD EXPLAIN THE DAMAGE OF THE URETER. AFTER REMOVING THE UAS, THEY PLACED A DOUBLE ¿J¿ STENT (DJ) AND PRESCRIBED HIGH DOSES OF ANTIBIOTICS TO PREVENT URO SEPSIS. NO UNINTENDED PORTION OF ANY OF THE DEVICES WAS LEFT IN THE PATIENT¿S BODY. THERE WERE NO ADDITIONAL PROCEDURES REQUIRED DUE TO THE REPORTED ISSUES. THERE HAS BEEN NO ADVERSE EFFECT TO THE PA

  Patient problems: No Code Available

  MAUDE report 7664560 ↗
• MalfunctionApr 12, 2018Split

  IT WAS REPORTED THAT PRIOR TO THE PROCEDURE, THE URETERAL FLEXOR HAD A SPLIT AT THE END OF THE TIP. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7424690 ↗
• MalfunctionApr 10, 2018Break; Entrapment of Device; Stretched; Uncoiled

  IT WAS REPORTED THAT THE GUIDEWIRE FOR THE FLEXOR PARALLEL URETERAL ACCESS SHEATH AND DILATORS KIT WAS CAUGHT IN THE OBTURATOR AND WAS FOUND TO BE ¿SHREDDED¿ AFTER REMOVAL. THERE WERE NO INJURIES OR ADDITIONAL PROCEDURES, AND NO PIECES OF THE DEVICE REMAINED IN THE PATIENT. ALSO, THE WIRE WAS SIGNIFICANTLY STRETCHED AND UNCOILED, ITS TIP WELD HAD SEPARATED, AND THE INNER LINING OF THE SHEATH WAS PARTIALLY SCRAPED OFF.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7416450 ↗
• InjuryOct 20, 2017Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  THE AREA REPRESENTATIVE REPORTED THAT DURING AN URETEROSCOPY PROCEDURE AFTER ACCESSING THE OLYMPUS FLEXIBLE VIDEO URETEROSCOPE A FEW TIMES A PLASTIC STRIP WAS OBSERVED UNDER ENDOSCOPIC IMAGE. THE PLASTIC STRIP WAS PULLED OUT ALONG WITH THE SCOPE AND IT WAS FOUND THAT THE PLASTIC STRIP IS LOOSELY ADHERED WITH THE FLEXOR PARALLEL URETERAL ACCESS SHEATH. NO FURTHER INFORMATION HAS BEEN PROVIDED REGARDING THE PATIENT OR THE PATIENT OUTCOME.

  Patient problems: No Information

  MAUDE report 6965253 ↗