Flexima APDLRecalls & reported problems across all models

We found 12 models of Flexima APDL by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 70 adverse event reports in the FDA's MAUDE database, received between Oct 25, 2018 and Sep 2, 2026 — classified as 3 deaths, 12 injuries, 55 malfunctions.

The most frequently reported specific device problem is “Break” (19 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 APDL problems

Flexima APDL models

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

• Flexima™ APDL M001271380

  TUBE, DRAINAGE, SUPRAPUBIC
  17 reports
• Flexima™ APDL M001271340

  TUBE, DRAINAGE, SUPRAPUBIC
  2 deaths16 reports
• Flexima™ APDL M001271960

  TUBE, DRAINAGE, SUPRAPUBIC
  1 death10 reports
• Flexima™ APDL M001271350

  TUBE, DRAINAGE, SUPRAPUBIC
  9 reports
• Flexima™ APDL M001271330

  TUBE, DRAINAGE, SUPRAPUBIC
  6 reports
• Flexima™ APDL M001275010

  TUBE, DRAINAGE, SUPRAPUBIC
  3 reports
• Flexima™ APDL M001275030

  TUBE, DRAINAGE, SUPRAPUBIC
  3 reports
• Flexima™ APDL M001271310

  TUBE, DRAINAGE, SUPRAPUBIC
  2 reports
• Flexima™ APDL M001281380

  TUBE, DRAINAGE, SUPRAPUBIC
  1 report
• Flexima™ APDL M001271320

  TUBE, DRAINAGE, SUPRAPUBIC
  1 report
• Flexima™ APDL M001281340

  TUBE, DRAINAGE, SUPRAPUBIC
  1 report
• Flexima™ APDL M001271390

  TUBE, DRAINAGE, SUPRAPUBIC
  1 report

Recent Flexima APDL adverse event reports

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

• MalfunctionSep 2, 2026Deformation Due to Compressive Stress

  Patient problems: Abdominal Pain; Diaphoresis; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 50570609 ↗
• InjuryJul 27, 2026Break; Deformation Due to Compressive Stress

  It was reported that cannula break and kink occurred, requiring an additional device. The non-stenosed target lesion was located in the mildly tortuous and mildly calcified vessel. A Flexima APDL Drainage Catheter was selected for use. The drainage catheter was placed without any issues noted during package opening, device preparation, or at the time of patient discharge. However, the patient returned three days after the procedure with a broken drain. The break was observed near the luer lock hub, at the interface where the drainage catheter meets the white component attached to the hub. The device was removed intact, and the catheter was replaced during an additional procedure. There were no patient complications as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50038381 ↗
• MalfunctionJan 21, 2026Break

  IT WAS REPORTED THE DEVICE MATERIAL BROKE AND AN UNRETRIEVED DEVICE FRAGMENT CAUSED A MINOR INJURY TO THE PATIENT. DURING FLEXIMA? APDL DEVICE, PART OF THE LOCKING LOOP SUTURE BROKE AND REMAINED INSIDE THE PATIENT. THE PHYSICIAN CUT THE FLEXIMA? APDL DEVIC JUST BELOW THE HUB AND PROCEEDED TO PULL THE DEVICE OUT WITHOUT FIRST INSERTING A WIRE TO STRAIGHTEN THE DRAIN. AS THE DEVICE WAS REMOVED, THE SUTURE IN THE LOCKING LOOP BROKE, RESULTING IN A DEVICE FRAGMENT BEING LEFT BEHIND IN THE PATIENT. ALTHOUGH THE EVENT WAS INITIALLY DESCRIBED AS ONGOING, ADDITIONAL INFORMATION RECEIVED THROUGH THE GOOD FAITH EFFORT (GFE) PROCESS STATES THE PATIENT IS DOING WELL WITH NO COMPLICATIONS. A CARDIOTHORACIC SURGEON EVALUATED THE RETAINED SUTURE FRAGMENT AND DETERMINED THAT SURGICAL REMOVAL WOULD POSE A HIGHER RISK THAN LEAVING THE FRAGMENT INSIDE OF THE PATIENT. THE PATIENT HAS BEEN CHECKED TWICE SINCE THE EVENT AND CONTINUES TO DO WELL WITHOUT ISSUES.

  Patient problems: Foreign Body In Patient

  MAUDE report 24136777 ↗
• MalfunctionDec 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 05DEC2025. A FLEXIMA ALL PURPOSE DRAINAGE WAS RETURNED TO THE QUALITY ASSURANCE WITH NO REPORTED ALLEGATION. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A STENT DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23865374 ↗
• MalfunctionDec 19, 2025Material Deformation; Adverse Event Without Identified Device or Use Problem; Material Deformation; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 7.3 FLEXIMA ALL PURPOSE DRAINAGE WAS SELECTED FOR USE. DURING THE PROCEDURE, THE STENT WAS DAMAGED DURING ATTEMPTED PLACEMENT OVER THE GUIDEWIRE. A TEAR OCCURRED ON THE DISTAL SIDE OF THE STENT, ALLOWING THE GUIDEWIRE TO EXIT THROUGH THE SIDE OF THE STENT. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE OF THE SAME MODEL WITHOUT ISSUE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23853477 ↗
• MalfunctionDec 12, 2025Obstruction of Flow; Adverse Event Without Identified Device or Use Problem; Obstruction of Flow; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 14NOV2025. IT WAS REPORTED THAT CATHETER WAS BLOCKED. A FLEXIMA APDL WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE CATHETER WAS BLOCKED AND THE LIQUID COULD NOT BE DRAWN OUT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. HOWEVER, DEVICE ANALYSIS REVEALED THE TIP OF THE TROCAR PERFORATED THE STENT, AND PART OF THE TIP IS VISIBLE THROUGH THE HOLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23790542 ↗
• MalfunctionNov 4, 2025Obstruction of Flow; Deformation Due to Compressive Stress; Positioning Problem; Obstruction of Flow; Deformation Due to Compressive Stress; Positioning Problem

  IT WAS REPORTED THAT THE DRAINAGE CATHETER WAS DIFFICULT TO REMOVE. A 6 FRENCH FLEXIMA APDL WAS SELECTED FOR USE TO DRAIN A BILIARY ABSCESS. THE DRAINAGE CATHETER WAS INSERTED INTO THE PATIENT, BUT THE DRAIN COULD NOT BE RELEASED. THE PLASTIC CANNULA FOLDED BACK ON ITSELF LIKE AN ACCORDION WHEN THE INTERNAL METAL COMPONENT WAS PULLED. THE DRAIN, THEREFORE, COULD NOT BE USED AS THE LUMEN WAS COVERED BY THE INTERNAL METAL PART. REMOVAL OF THE DRAIN WAS DIFFICULT BECAUSE OF THE ACCORDION LIKE DAMAGE, AND RESULTED IN PAIN DURING REMOVAL. A NEW DRAIN WAS SUCCESSFULLY INSERTED. THERE WERE NO FURTHER PATIENT COMPLICATIONS AS A RESULT OF THE EVENT.

  Patient problems: Pain

  MAUDE report 23468127 ↗
• MalfunctionOct 29, 2025Difficult to Insert; Defective Device; Adverse Event Without Identified Device or Use Problem; Difficult to Insert; Defective Device; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 15OCT2025. IT WAS REPORTED THAT THE DEVICE DID NOT FUNCTION AS EXPECTED. A FLEXIMA ALL PURPOSE DRAINAGE CATHETER WAS SELECTED FOR USE IN A PROCEDURE. DURING THE PROCEDURE, THE FLEXIMA ALL PURPOSE DRAINAGE CATHETER WAS DAMAGED AND DID NOT FUNCTION AS EXPECTED. A DIFFERENT DEVICE OF THE SAME MODEL WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. HOWEVER, DEVICE ANALYSIS REVEALED THE DEVICE MATERIAL SEPARATED AND DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23417252 ↗
• MalfunctionOct 15, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A BROKEN HUB OCCURRED THAT REQUIRED DEVICE REPLACEMENT. A FLEXIMA ALL PURPOSE DRAINAGE CATHETER WAS SUCCESSFULLY IMPLANTED. HOWEVER, THE DRAIN FRACTURED AT THE HUB AFTER THE PATIENT WAS SENT HOME WHICH RESULTED IN UNDESIRED SENSATIONS. THE PATIENT WAS REQUIRED TO RETURN TO THE HOSPITAL FOR DEVICE REMOVAL AND REPLACEMENT WITH A NEW DRAINAGE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23290201 ↗
• MalfunctionSep 30, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT SUTURE BREAK OCCURRED. A 12F FLEXIMA APDL DRAINAGE CATHETER WAS SELECTED FOR USE. POST CATHETER PLACEMENT, IT WAS NOTED THE CATHETER WAS BREAKING AT THE HUB AND SUTURE AREA. THE DEVICE WAS REMOVED FROM THE PATIENT IN ONE PIECE, AND IT WAS EXCHANGED WITH A NEW DRAINAGE CATHETER. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23183622 ↗
• MalfunctionSep 30, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT SUTURE BREAK OCCURRED. A 12F FLEXIMA APDL DRAINAGE CATHETER WAS SELECTED FOR USE. POST CATHETER PLACEMENT, IT WAS NOTED THE CATHETER WAS BREAKING AT THE HUB AND SUTURE AREA. THE DEVICE WAS REMOVED FROM THE PATIENT IN ONE PIECE, AND IT WAS EXCHANGED WITH A NEW DRAINAGE CATHETER. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23183621 ↗
• InjurySep 22, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A BROKEN HUB OCCURRED THAT REQUIRED DEVICE REPLACEMENT. A FLEXIMA ALL PURPOSE DRAINAGE CATHETER WAS SUCCESSFULLY IMPLANTED. HOWEVER, WITHIN ONE WEEK IT WAS OBSERVED THAT THE DRAINAGE CATHETER BROKE AT THE HUB WHICH RESULTED IN PAIN. THE PATIENT WAS REQUIRED TO RETURN TO THE HOSPITAL FOR DEVICE REMOVAL AND REPLACEMENT WITH A NEW DRAINAGE CATHETER. IT WAS FURTHER REPORTED THAT NO PAIN AND DISCOMFORT WAS FELT BY THE PATIENT, AND THE DEVICE WAS EXCHANGED FOR A NEW DRAIN. IT WAS NOTED THAT THERE WAS NO DIFFICULTY CHANGING THE DRAINAGE CATHETER BECAUSE THEY WOULD USUALLY BE CUT.

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

  MAUDE report 23110947 ↗
• InjuryAug 22, 2025Material Separation; Defective Device; Material Separation; Defective Device

  IT WAS REPORTED THAT A PORTION OF THE DEVICE WAS LEFT IN THE PATIENT, AND ADDITIONAL INTERVENTION WAS REQUIRED. A FLEXIMA? APDL WAS SELECTED FOR USE. THE PATIENT ATTENDED A HOSPITAL APPOINTMENT AS PLANNED FOR DRAIN REVIEW. DRAIN OUTPUT WAS BELOW THRESHOLD, SO IT WAS DETERMINED THAT THE DRAIN COULD BE REMOVED. THE DRAIN APPEARED UNREMARKABLE, BUT WAS CHALLENGING TO REMOVE. DESPITE DISENGAGING THE PIGTAIL, THERE WAS RESISTANCE. THEREFORE, THE DECISION WAS MADE TO CUT THE DRAIN AND WITHDRAW, WHICH WAS AN ACCEPTED PRACTICE IN INTERVENTIONAL RADIOLOGY (IR). THIS ALLOWED THE DRAIN TO BE EASILY REMOVED. HOWEVER, THE DRAIN STRING REMAINED TETHERED. THE STRING WAS CUT AWAY FROM THE DRAIN, BUT IT COULD NOT BE REMOVED. A SPECIALIST WAS BROUGHT IN WHO ATTEMPTED TO REMOVE THE STRING BUT COULD NOT. DESPITE EFFORTS IN THE IR LAB WITH INTRODUCERS, THE STRING WAS UNABLE TO BE REMOVED. THEREFORE, THE STRING WAS CUT SHORT BY AN IR FELLOW AND LEFT WITHIN THE PATIENT'S ABDOMINAL WALL. THE DEVICE APPEARED TO HAVE BEEN INSERTED, DISENGAGED, AND REMOVED APPROPRIATELY. IT WAS FURTHER REPORTED THAT THE DRAIN WAS IMPLANTED FOR SUB-CUTANEOUS ABDOMINAL COLLECTION FOLLOWING AN ABDOMINAL SURGERY. THE DRAIN HAD B

  Patient problems: Foreign Body In Patient

  MAUDE report 22873561 ↗
• MalfunctionAug 15, 2025Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON THE DEVICE ANALYSIS COMPLETED ON 22JUL2025. IT WAS REPORTED THAT FLEXIMA DRAIN SEPARATED FROM THE HUB WHEN REMOVING. A FLEXIMA? ALL PURPOSE DRAINAGE WAS SELECTED FOR USE. DURING THE PROCEDURE, THE FLEXIMA DRAIN DISCONNECTED FROM THE HUB WHILE BEING REMOVED FROM THE PATIENT AND WAS SUBSEQUENTLY RETRIEVED IN TWO SEPARATE PIECES. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED THE SUTURE WAS DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22816654 ↗
• MalfunctionApr 29, 2025Fracture; Adverse Event Without Identified Device or Use Problem; Fracture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT GUIDEWIRE FRACTURE OCCURRED. A FLEXIMA APDL DRAINAGE CATHETER WAS SELECTED FOR USE IN A BILE DUCT. DURING INSERTION, IT WAS NOTED THAT THE GUIDEWIRE WAS FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21930346 ↗

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