Flexima™ M001272600Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 08714729454953), received between Oct 23, 2018 and Sep 5, 2023 — classified as 3 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Break” (9 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 16, 2026.

Most reported problems

Recent adverse event reports

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

• MalfunctionSep 5, 2023Break; Break

  IT WAS REPORTED THAT THE STYLET WAS DIFFICULT TO REMOVED AND WAS BROKE. A FLEXIMA CATHETER DRAINAGE WAS SELECTED FOR USE. DURING THE PROCEDURE, THE INNER STYLET WOULD NOT COME OUT AFTER PLACING THE BILIARY DRAIN, FURTHERMORE, IT GOT BROKE INTO PIECES AS THE PHYSICIAN HAD TO USE FORCE TO PULL OUT THE PLASTIC STYLET AND TO DEPLOY THE PIGTAIL. ALL THE BROKEN PIECES WERE REMOVED BUT THE PROCEDURE WAS PROLONGED FOR ADDITIONAL OF 2 HOURS. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17686315 ↗
• MalfunctionAug 28, 2023Break; Defective Device; Break; Defective Device

  IT WAS REPORTED THAT THE DEVICE WAS PULLED AND FORCED OUT WITH EXTREME PAIN TO PATIENT. AN 8FR X 35CM FLEXIMA DRAINAGE CATHETER WAS USED FOR INSERTING INTERNAL AND EXTERNAL BILIARY DRAIN. DURING THE PROCEDURE, AFTER PLACING THE DRAIN, THE PLASTIC INNER STYLET WOULD NOT COME OUT AND EVENTUALLY BROKE. THE PHYSICIAN DECIDED TO CUT THE CATHETER HOPING THAT WOULD RELEASE THE PIGTAIL ON THE END OF THE CATHETER, BUT IT DID NOT HELP. THE DEVICE WAS PULLED AND FORCED OUT WHICH CAUSED EXTREME PAIN TO PATIENT. EVENTUALLY, THE PHYSICIAN WAS ABLE TO KEEP THE WIRE ACCESS, WHILE PULLING OUT THE CATHETER WITH THE PIGTAIL STILL FORMED AND PLACED A NON-BOSTON SCIENTIFIC BILIARY DRAIN OVER THE WIRE. THE DEVICE WAS COMPLETELY REMOVED FROM PATIENT'S BODY AND THE PROCEDURE WAS COMPLETED USING AN ALTERNATE DEVICE.

  Patient problems: Pain

  MAUDE report 17638142 ↗
• MalfunctionMay 15, 2023Difficult to Remove; Difficult to Remove

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2023. IT WAS REPORTED THAT THE STIFFENING CANNULA HAS BECOME LODGED IN THE DRAIN. A FLEXIMA DRAINAGE CATHETER WAS SELECTED FOR USE IN THE BILIARY TRACT. DURING THE PROCEDURE, THE DRAINS HAD BEEN FLUSHED AND SOAKED IN SALINE PRIOR TO THE LOADING OF THE STIFFENING CANNULA. HOWEVER, IT WAS NOTED THAT THE STIFFENING CANNULA HAS BECOME LODGED IN THE DRAIN, AND IT HAS NOT BEEN ABLE TO BE REMOVED, NECESSITATING THE REMOVAL OF THE ENTIRE DRAIN. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE AND NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE DISTAL TIP OF THE STENT WAS OBSERVED BROKEN AT THE DISTAL TIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16936050 ↗
• MalfunctionApr 7, 2023Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT THE DEVICE WAS FRACTURED. THE TARGET LESION WAS LOCATED IN THE BILIARY ROUTE. A FLEXIMA CATHETER DRAINAGE WAS SELECTED FOR USE. DURING INSERTION, IT WAS NOTED THAT THE DEVICE GOT KINKED AT THE PROXIMAL PART AND THE MIDDLE THIRD OF THE CATHETER WAS FRACTURED. IT WAS NOT POSSIBLE FOR THE DEVICE TO ADVANCE, SO ALL PART OF THE DEVICE WAS PULLED OUT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16702646 ↗
• MalfunctionFeb 9, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT THE SUTURE WAS SEPARATED. A FLEXIMA WAS SELECTED FOR USE. DURING REMOVAL OF THE DEVICE, IT WAS NOTED THAT THE SUTURE COULDN'T BE FOUND. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16342549 ↗
• MalfunctionFeb 8, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT THE SUTURE WAS SEPARATED. A FLEXIMA WAS SELECTED FOR USE. DURING REMOVAL OF THE DEVICE, IT WAS NOTED THAT THE SUTURE COULDN'T BE FOUND. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16329164 ↗
• MalfunctionFeb 8, 2023Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT REMOVAL DIFFICULTY OCCURRED. A FLEXIMA WAS SELECTED FOR USE. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. IT WAS NOTED THAT DURING REMOVAL, THE PHYSICIAN HAD A HARD TIME WITHDRAWING THE DEVICE, BUT THEY WERE ABLE TO REMOVE IT. NO INTERVENTION WAS REQUIRED. THERE WERE NO COMPLICATIONS REPORTED AND THE PATIENT WAS GOOD POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16328969 ↗
• MalfunctionDec 12, 2022Break; Break

  IT WAS REPORTED THAT THE CATHETER BROKE. A FLEXIMA CATHETER DRAINAGE WAS SELECTED FOR USE FOR BILIARY DRAINACE EXCHANGE. DURING THE PROCEDURE, UPON INTRODUCTION WHILE PULLING THE PIN OFF THE WIRE, IT WAS NOTED THAT THE PLASTIC INNER BROKE. THE ENTIRE DEVICE WAS REMOVED INTACT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15960177 ↗
• MalfunctionSep 29, 2022Break; Break

  IT WAS REPORTED THAT THE CATHETER SPLIT. A VTCB/8.3 FLEXIMA REGULAR W/RO FLEXIMA WAS SELECTED FOR USE IN A BILIARY DRAINAGE PROCEDURE. AFTER PLACING THE DEVICE INTO THE PATIENT, IT WAS NOTED THAT THE CATHETER HAS SPLIT WHEN ATTEMPTING TO REMOVE THE INNER DILATOR. THE DEVICE WAS REMOVED OVER THE WIRE. ANOTHER CATHETER WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15506176 ↗
• InjuryFeb 21, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT ADDITIONAL INTERVENTION WAS REQUIRED TO REMOVE THE SUTURE. THE TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS LIVER/COMMON BILE DUCT ARTERY. A FLEXIMA BILIARY CATHETER DRAINAGE HAD BEEN PREVIOUSLY PLACED. DURING REMOVAL OF THE DRAINAGE CATHETER, THE SUTURE BECAME STUCK AND COULD NOT BE REMOVED TOGETHER WITH THE DRAINAGE CATHETER. THE SUTURE THEN BROKE AND REMAINED INSIDE THE PATIENT AFTER REMOVAL OF THE DRAIN. ADDITIONAL INTERVENTION WAS REQUIRED TO SUCCESSFULLY REMOVE THE SUTURE FROM THE PATIENT. THE PATIENT DID EXPERIENCE PAIN DURING REMOVAL, HOWEVER, THERE WERE NO FURTHER PATIENT COMPLICATION. THE PROCEDURE WAS COMPLETED.

  Patient problems: Pain

  MAUDE report 13569690 ↗
• MalfunctionFeb 12, 2020Break; Break

  IT WAS REPORTED THAT THE WIRE WAS BROKEN. A 8.3 FLEXIMA CATHETER WAS SELECTED FOR USE. DURING PREPARATION, IT WAS DIRECTLY NOTED THAT UPON OPENING OF THE DEVICE, THE TIP OF THE CATHETER WIRE WAS PARTIALLY SEPARATED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9699456 ↗
• MalfunctionMay 23, 2019Break; Break

  IT WAS REPORTED THAT A DEVICE FRACTURE OCCURRED. A VTCB/8.3 FLEXIMA WAS SELECTED FOR USE. DURING PREPARATION, IT WAS NOTED THAT THE LOCKING SUTURE WAS BROKEN. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS REPORTED AND PATIENT IS STABLE.

  Patient problems: No Patient Involvement

  MAUDE report 8636639 ↗
• MalfunctionApr 17, 2019Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT THERE WAS A HOLE IN THE STERILE PACKAGE. A FLEXIMA DRAINAGE CATHETER WAS SELECTED FOR USE. IT WAS NOTED THAT THERE WAS A HOLE IN THE STERILE PACKAGING AND THE DEVICE WAS NOT USED. NO PATIENT WAS INVOLVED IN THE EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 8523119 ↗
• InjuryOct 25, 2018Break; Break

  IT WAS REPORTED THAT THE DISTAL PART OF THE SUTURE BROKE AND REMAINED INSIDE PATIENT. THE TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED BILIARY TRACT. A VTCB/8.3 FLEXIMA WAS SELECTED FOR USE. THE CATHETER WAS ATTEMPTED TO WITHDRAW AFTER A FEW DAYS OF DRAINAGE. DURING WITHDRAWAL, IT WAS NOTED THAT THE DISTAL PART OF THE SUTURE DETACHED SOMEWHERE INSIDE THE PATIENT'S BODY AND WAS UNABLE TO BE WITHDRAWN. THE SEPARATED SUTURE WAS THEN TRIED TO PULLED OUT BY HAND AND BY FORCEP BUT IT COULD NOT BE REMOVED. AFTER WITHDRAWAL OD THE FLEXIMA CATHETER AND THE REMAINING SUTURE INSIDE, THE PROXIMAL PART OF THE SUTURE WAS CUT BY SCISSOR AND THE PROCEDURE WAS ENDED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND PATIENT'S STATUS WAS STABLE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8005695 ↗
• InjuryOct 23, 2018Break; Break

  IT WAS REPORTED THAT THE DISTAL PART OF THE SUTURE BROKE AND WAS UNABLE BE REMOVED. A STENOSED TARGET LESION WAS LOCATED AT MILDLY TORTUOUS AND MODERATELY CALCIFIED BILIARY TRACT. A VTCB/8.3 FLEXIMA WAS SELECTED FOR USED. THE CATHETER WAS ATTEMPTED TO WITHDRAW AFTER FEW DAYS OF DRAINAGE. DURING WITHDRAWAL, IT WAS REPORTED THAT THE DISTAL PART OF THE CATHETER LOCKING STRING WAS UNABLE TO BE REMOVED. IT WAS REMAINED INSIDE THE PATIENT'S BODY. THERE WERE NO PATIENT'S COMPLICATIONS REPORTED. IT WAS FURTHER REPORTED THAT THERE WERE NO ADDITIONAL INTERVENTIONS DONE TO REMOVED THE DISCONNECTED SUTURE. THE PATIENT'S CONDITION POST-PROCEDURE WAS STABLE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7995731 ↗