FleximaRecalls & reported problems across all models

We found 20 models of Flexima by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 55 adverse event reports in the FDA's MAUDE database, received between Oct 23, 2018 and Sep 15, 2026 — classified as 11 injuries, 44 malfunctions.

The most frequently reported specific device problem is “Break” (22 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 Flexima problems

Flexima models

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

• Flexima™ M001272600

  CATHETER, BILIARY, DIAGNOSTIC
  15 reports
• Flexima™ M001271800

  CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY
  6 reports
• Flexima™ M001274120

  STENT, URETERAL
  5 reports
• Flexima™ M001272610

  CATHETER, BILIARY, DIAGNOSTIC
  5 reports
• Flexima™ M001271790

  CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY
  4 reports
• Flexima™ M001274030

  STENT, URETERAL
  3 reports
• Flexima™ M001271650

  CATHETER, BILIARY, DIAGNOSTIC
  2 reports
• Flexima™ M001271860

  CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY
  2 reports
• Flexima™ M001274020

  STENT, URETERAL
  2 reports
• Flexima™ M001271560

  CATHETER, BILIARY, DIAGNOSTIC
  1 report
• Flexima™ M001271660

  CATHETER, BILIARY, DIAGNOSTIC
  1 report
• Flexima™ M001271810

  CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY
  1 report
• Flexima™ M001271820

  CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY
  1 report
• Flexima™ M001271870

  CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY
  1 report
• Flexima™ M001274000

  STENT, URETERAL
  1 report
• Flexima™ M001274110

  STENT, URETERAL
  1 report
• Flexima™ M001274130

  STENT, URETERAL
  1 report
• Flexima™ M001274180

  STENT, URETERAL
  1 report
• Flexima™ M001272620

  CATHETER, BILIARY, DIAGNOSTIC
  1 report
• Flexima™ M001272630

  CATHETER, BILIARY, DIAGNOSTIC
  1 report

Recent Flexima adverse event reports

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

• InjurySep 15, 2026Difficult or Delayed Positioning; Deformation Due to Compressive Stress

  It was reported that the stent was buckled, resulting in subsequent device explant.A Flexima? device was selected for use in a left antegrade ureteric stenting procedure. The patient was numbed using local anesthesia. During the procedure, the stent was able to be implanted with difficulty, but was shown to have buckled, and was protruding from the nephrostomy site. The physician performed multiple retrieval attempts with a snare to reposition the stent , but was ultimately unsuccessful. The index procedure was cancelled. On August 04, 2026, the patient underwent an additional procedure to retrieve the stent and implant a new stent. There were no patient complications reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50774539 ↗
• MalfunctionJul 7, 2026Difficult to Advance; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2026. IT WAS REPORTED THAT DIFFICULTY ADVANCING OCCURRED. THE TARGET LOCATION WAS THE URETER. DURING PLACEMENT OF A FLEXIMA URETERAL STENT FOR TREATMENT OF URETERAL OBSTRUCTION, MILD RESISTANCE WAS ENCOUNTERED DURING ADVANCEMENT. DURING THE DEPLOYMENT PHASE, THE STENT FAILED TO FULLY DEPLOY AND WAS PARTIALLY DEPLOYED. THE DEVICE WAS SUCCESSFULLY REMOVED WITHOUT DIFFICULTY. NO DEVICE DAMAGE OR KINKING WAS OBSERVED. NO PATIENT OR ANATOMICAL COMPLICATIONS WERE REPORTED, NO ADDITIONAL INTERVENTION WAS REQUIRED, AND THE PATIENT REMAINED STABLE WITH NO REPORTED ADVERSE OUTCOME. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A STENT DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25740368 ↗
• MalfunctionDec 18, 2025Difficult to Advance; Adverse Event Without Identified Device or Use Problem; Difficult to Advance; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 24NOV2025. THE TARGET LESION WAS LOCATED IN THE KIDNEY TO THE BLADDER. A FLEXIMA WAS SELECTED FOR USE. DURING THE PROCEDURE, A HARD RESISTANCE WAS FELT WHEN THE CATHETER WAS PUSHED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. HOWEVER, DEVICE ANALYSIS REVEALED THE SUTURE RETURNED CUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23843477 ↗
• MalfunctionDec 15, 2025Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE PROCEDURE WAS CANCELLED. THIS FLEXIMA? DRAINAGE CATHETER SYSTEM KIT WAS SELECTED FOR A URETERAL STENT INJECTION PROCEDURE. DURING THE PROCEDURE, THE DUAL LAYER PORTION OF THE DISTAL TIP WAS NOT INSERTED INTO THE 8FR SHEATH. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE DISTAL LAYER PORTION COULD NOT BE ADVANCED INTO THE 8FR SHEATH. THE PHYSICIANS HAD TO CUT OFF THE PROBLEMATIC SECTION WITH SCISSORS BEFORE COMPLETING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23807110 ↗
• InjuryDec 10, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT HUB DETACHMENT OCCURRED. A FLEXIMA WAS SELECTED FOR USE. THE NEPHROSTOMY TUBE WAS PLACED ON (B)(6) 2025. FIFTEEN DAYS POST PROCEDURE, THE PATIENT RETURNED BECAUSE THE NEPHROSTOMY TUBE WAS SEPARATED FROM THE HUB. THE TUBE WAS REMOVED, AND IT WAS REPLACED WITH A NEW NEPHROSTOMY TUBE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT AND THE PATIENT FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23767294 ↗
• MalfunctionNov 13, 2025Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT CATHETER FRACTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE LIVER. A FLEXIMA DRAINAGE CATHETER WAS SELECTED FOR USE IN A PERCUTANEOUS TRANSHEPATIC BILIARY STENTING (PTBS) AND PERCUTANEOUS TRANSHEPATIC CHOLANGIODRAINAGE (PTCD) PROCEDURE. DURING PREPARATION, IT WAS FOUND THAT THE CATHETER WAS FRACTURED AND IT COULD NOT BE USED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WAS NO PATIENT INJURY AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23543427 ↗
• InjuryOct 30, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT MEDICAL INTERVENTION WAS REQUIRED TO REMOVE A DRAINAGE CATHETER. A FLEXIMA URETERIC DRAINAGE CATHETER WAS SELECTED FOR USE. THE DRAINAGE CATHETER WAS SUCCESSFULLY INSERTED, HOWEVER, WHEN THE STABILIZER NEEDED TO BE REMOVED, IT BECAME STUCK. WHILE ATTEMPTING TO REMOVE THE STABILIZER, THE ENTIRE DRAINAGE CATHETER STENT WAS MOVING WITH IT AND THE GUIDEWIRE. THE DRAINAGE CATHETER WAS STUCK IN SITU, AND THE PATIENT WAS SENT TO UROLOGY TO HAVE THE DRAINAGE CATHETER REMOVED AND REPLACED WITH ANOTHER DRAINAGE CATHETER, LIKE NEPHROURETERAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23429344 ↗
• MalfunctionOct 15, 2025Deformation Due to Compressive Stress; Adverse Event Without Identified Device or Use Problem; Deformation Due to Compressive Stress; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 17SEP2025. IT WAS REPORTED THAT THE SHEATH BUCKLED. A VTC/8/K FLEXIMA REGULAR WAS SELECTED FOR A NEPHROSTOMY PROCEDURE. DURING PREPARATION, THE 0.018 WIRE SNAGGED WITHIN THE THREE-PART NEEDLE SHEATH AND CAUSED DAMAGE TO THE DEVICE ITSELF. THE VTC/8/K FLEXIMA REGULAR WAS NOT USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE RADIOPAQUE MARKER WAS TORN AT THE MIDDLE TO TIP SECTION OF THE SHEATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23302274 ↗
• MalfunctionJul 24, 2025Difficult to Advance; Adverse Event Without Identified Device or Use Problem; Difficult to Advance; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 30JUN2025 IT WAS REPORTED THAT DEVICE DIFFICULT TO ADVANCE OCCURRED. THE 50-60% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MILD CALCIFIED URETER. A FLEXIMA WAS USED FOR PROCEDURE. DURING THE PROCEDURE, THE PHYSICIAN FELT RESISTANCE WHEN THE CATHETER WAS PUSHED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. HOWEVER, THE ANALYSIS OF THE RETURNED DEVICE SHOWED A DETACHED SUTURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22591254 ↗
• MalfunctionMar 27, 2025Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT A TEAR IN THE PACKAGING OCCURRED. A 10.3 FLEXIMA DRAINAGE CATHETER WAS USED FOR PERCUTANEOUS TRANSHEPATIC BILIARY DRAINAGE (PTBD) IN THE GALLBLADDER. DURING UNPACKING, IT WAS OBSERVED THAT THERE WAS A TEAR IN THE PACKAGING FROM THE TOP PART AND THE DRAINAGE CATHETER WAS OUT FROM THE TORN PART. THE DEVICE WAS NO LONGER STERILE; THEREFORE, IT WAS NOT USED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21711001 ↗
• MalfunctionDec 6, 2024Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THE CANNULA AND GUIDEWIRE WERE DIFFICULT TO REMOVE. A FLEXIMA DRAINAGE CATHETER SYSTEM AND AMPLATZ-PI GUIDEWIRE WERE SELECTED FOR USE. DURING AN ANTEGRADE URETERIC STENT STENTING, THE DRAINAGE CATHETER CANNULA WOULD NOT DETACH AND WAS LODGED IN THE DRAINAGE CATHETER STENT. THE AMPLATZ-PI GUIDEWIRE COULD NOT BE REMOVED EASILY, AND REQUIRED EXCESSIVE FORCE TO REMOVE IT. AS A RESULT, THE AMPLATZ-PI GUIDEWIRE FRAYED AND FRACTURED WHEN RETRACTED. THE PATIENT WAS RETURNED TO THE WARD WITH THE STENT IN PLACE WITH THE CANNULA ATTACHED ACTING LIKE THE DRAIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20864250 ↗
• MalfunctionAug 13, 2024Unsealed Device Packaging; Packaging Problem; Unsealed Device Packaging; Packaging Problem

  IT WAS REPORTED THAT DEVICE CONTAMINATION OCCURRED. A FLEXIMA CATHETER DRAINAGE WAS RECEIVED WITH ITS PACKAGE DEFECTIVE. A PART OF THE PRODUCT WAS OUTSIDE OF THE PACKAGE, AND A VISIBLE TEAR WAS FOUND IN THE INNER PACKAGING. THE PROCEDURE WAS COMPLETED USING A DIFFERENT DEVICE. THERE WAS NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19972847 ↗
• MalfunctionJun 26, 2024Break; Break

  IT WAS REPORTED THAT A CATHETER BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE VESSEL OF THE LIVER. THE PATIENT WAS BROUGHT IN FOR A DRAIN EXCHANGE OF A PREVIOUSLY IMPLANTED FLEXIMA DRAINAGE CATHETER FROM 2 WEEK EARLIER. HOWEVER, IT WAS NOTED THAT THE DRAIN HAD BROKEN NEAR THE HUB. THE BROKEN FLEXIMA DRAINAGE CATHETER WAS SUCCESSFULLY EXCHANGED FOR A NEW DEVICE, SAME MODEL. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19619488 ↗
• MalfunctionApr 2, 2024Difficult to Advance; Difficult to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 06MAR2024. IT WAS REPORTED THAT THE DEVICE WAS DIFFICULT TO ADVANCE. AN 8F FLEXIMA NEPHROSTOMY CATHETER SYSTEM WAS SELECTED FOR USE. DURING THE PROCEDURE, A HARD RESISTANCE WAS ENCOUNTERED UPON PUSHING THE CATHETER IN. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO COMPLICATIONS REPORTED, AND THE PATIENT'S CONDITION WAS NORMAL. HOWEVER, INVESTIGATION OF THE RETURNED DEVICE REVEALED THAT THE SUTURE WAS DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19021708 ↗
• MalfunctionJan 23, 2024Unsealed Device Packaging; Tear, Rip or Hole in Device Packaging; Unsealed Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT DEVICE PACKAGING SEAL WAS COMPROMISED. A 10.3 FLEXIMA DRAINAGE CATHETER WAS SELECTED FOR USE. HOWEVER, IT WAS NOTED THAT THERE WAS A HOLE IN THE PACKAGING, AND THE SEAL WAS COMPROMISED. THERE WAS NO PATIENT OR PROCEDURE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18565438 ↗

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