Percuflex PlusRecalls & reported problems across all models
Boston Scientific Corporation · 35 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 303
- Deaths reported
- 1
- Injuries reported
- 87
- Recalls
- 0
We found 35 models of Percuflex Plus by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 303 adverse event reports in the FDA's MAUDE database, received between Nov 16, 2016 and Sep 22, 2026 — classified as 1 death, 87 injuries, 215 malfunctions.
The most frequently reported specific device problem is “Break” (133 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
Reports received per month, all models
Most reported Percuflex Plus problems
Device problems
- Break133
- Calcified70
- Adverse Event Without Identified Device or Use Problem42
- Detachment of Device or Device Component42
- Material Deformation31
- Difficult to Remove25
- Material Split, Cut or Torn23
- Deformation Due to Compressive Stress15
Patient problems
- No Clinical Signs, Symptoms or Conditions188
- No Consequences Or Impact To Patient62
- No Known Impact Or Consequence To Patient22
- Pain13
- Unspecified Infection9
- Abdominal Pain3
- Hematuria3
- Sepsis3
Percuflex Plus models
35 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Percuflex™ Plus M0061752530STENT, URETERAL1 death99 reports
- Percuflex™ Plus M0061752630STENT, URETERAL46 reports
- Percuflex™ Plus M0061752540STENT, URETERAL35 reports
- Percuflex™ Plus M0061752520STENT, URETERAL20 reports
- Percuflex™ Plus M0061752620STENT, URETERAL17 reports
- Percuflex™ Plus M006175254050STENT, URETERAL15 reports
- Percuflex™ Plus M006175253050STENT, URETERAL11 reports
- Percuflex™ Plus M0061752730STENT, URETERAL10 reports
- Percuflex™ Plus M0061752640STENT, URETERAL8 reports
- Percuflex™ Plus M006175263010STENT, URETERAL6 reports
- Percuflex™ Plus M0061752720STENT, URETERAL5 reports
- Percuflex™ Plus M0061751970STENT, URETERAL4 reports
- Percuflex™ Plus M006175253080STENT, URETERAL4 reports
- Percuflex™ Plus M0061752510STENT, URETERAL2 reports
- Percuflex™ Plus M0061752740STENT, URETERAL1 report
- Percuflex™ Plus M0061752830STENT, URETERAL1 report
- Percuflex™ Plus M0061751950STENT, URETERAL1 report
- Percuflex™ Plus M0061751980STENT, URETERAL1 report
- Percuflex™ Plus M0061751990STENT, URETERAL1 report
- Percuflex™ Plus M0061752610STENT, URETERAL1 report
- Percuflex™ Plus M0061752650STENT, URETERAL1 report
- Percuflex™ Plus M0061752810STENT, URETERAL1 report
- Percuflex™ Plus M006175262080STENT, URETERAL1 report
- Percuflex™ Plus M006175262110STENT, URETERAL1 report
- Percuflex™ Plus M006175263080STENT, URETERAL1 report
- Percuflex™ Plus M006175263110STENT, URETERAL1 report
- Percuflex™ Plus M006175250050STENT, URETERAL1 report
- Percuflex™ Plus M006175252050STENT, URETERAL1 report
- Percuflex™ Plus M006175262010STENT, URETERAL1 report
- Percuflex™ Plus M006175273010STENT, URETERAL1 report
- Percuflex™ Plus M006175262090STENT, URETERAL1 report
- Percuflex™ Plus M006175262050STENT, URETERAL1 report
- Percuflex™ Plus M006175253190STENT, URETERAL1 report
- Percuflex™ Plus M006175253180STENT, URETERAL1 report
- Percuflex™ Plus M006175263190STENT, URETERAL1 report
Recent Percuflex Plus adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 22, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50861534 ↗InjurySep 18, 2026Break; Deformation Due to Compressive Stress; Detachment of Device or Device Component; Material Deformation
It was reported that a Percuflex Plus Ureteral stent was implanted into the right ureter of the patient during a double J (JJ) stent placement performed on, (b)(6) 2026. Post procedure, on the same date, the patient experienced abdominal pain. The following day, (b)(6) 2026, X-ray imaging revealed that the stent had broken inside the patient. On (b)(6) 2026, endoscopic surgery was performed to remove the broken stent, however, the coil could not be removed and was left unretrieved. The patient's condition was stable at the conclusion of this procedure, however, further hospital observation was required. On (b)(6) 2026, another endoscopic surgery was performed and successfully retrieved all broken fragments. There was no information if a new stent was replaced and there was no information if medication was given for pain, however, it was reported that the adverse event of pain was resolved. The patient's condition following the procedure was stable.
Patient problems: Abdominal Pain; Foreign Body In Patient
MAUDE report 50817285 ↗MalfunctionSep 10, 2026Break
It was reported that a percuflex plus ureteral stent was used during transurethral laser lithotripsy and stone removal of the ureter/renal pelvis plus transurethral ureteral stent placement under general anesthesia with endotracheal intubation. During procedure, it was discovered that the stent was broken. The procedure was completed with another of the same stent. there were no patient complications as a result of this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50713512 ↗MalfunctionSep 9, 2026Break; Detachment of Device or Device Component
It was reported that a Percuflex Plus was to be used in a lithotripsy procedure. During unpacking, it was found that the stent was fractured. The procedure was completed with another of the same device and there were no patient complications reported. The patient condition following the procedure was stable.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50683490 ↗MalfunctionAug 20, 2026Difficult to Advance; Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50351078 ↗MalfunctionMay 18, 2026Deformation Due to Compressive Stress; Difficult to Advance
IT WAS REPORTED THAT A PERCUFLEX PLUS URETERAL STENT WAS USED IN AN INDWELLING FLEXIBLE URETEROSCOPE FOR RENAL CALCULI PROCEDURE. DURING THE PROCEDURE AND INSIDE THE PATIENT, IT WAS NOTICED THAT THE STENT COULD NOT BE ADVANCED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE AND THERE WAS NO PATIENT COMPLICATIONS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25210923 ↗MalfunctionMay 7, 2026Material Deformation
IT WAS REPORTED THAT A PERCUFLEX PLUS URETERAL STENT WAS USED IN A HOLMIUM LASER LITHOTRIPSY PROCEDURE IN THE KIDNEY. DURING INSERTION AND INSIDE THE PATIENT, IT WAS NOTICED THAT THE TIP OF THE STENT WAS DEFORMED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25108648 ↗MalfunctionApr 22, 2026Break
IT WAS REPORTED THAT DURING A PROCEDURE, A PERCUFLEX URETERAL STENT WAS TO BE USED. WHEN THE DEVICE WAS OPENED, IT WAS NOTICED THAT THE STENT WAS BROKEN. ANOTHER STENT WAS OPENED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24955488 ↗MalfunctionApr 21, 2026Break; Material Split, Cut or Torn
IT WAS REPORTED THAT A PERCUFLEX PLUS URETERAL STENT WAS TO BE USED IN A RETROGRADE INTRARENAL SURGERY (RIRS) PROCEDURE. DURING UNPACKING, IT WAS FOUND THAT THE STENT WAS BROKEN. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24934410 ↗MalfunctionApr 9, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT A PERCUFLEX PLUS URETERAL STENT WAS USED IN A URETEROSCOPIC INTERVENTION PROCEDURE IN THE URETER. DURING PROCEDURE CLOSURE, IT WAS NOTICED THAT THE FRONT END OF THE STENT WAS FRACTURED BUT DID NOT FALL INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE AND THERE WERE NO PATIENT COMPLICATIONS REPORTED. A PHOTO OF THE COMPLAINT DEVICE WAS PROVIDED AND SHOWED THAT THE COIL WAS DETACHED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24837969 ↗MalfunctionMar 31, 2026Break; Nonstandard Device
IT WAS REPORTED THAT, DURING A LITHOTRIPSY PROCEDURE, A PERCUFLEX PLUS URETERAL STENT WAS INTENDED TO BE USED. DURING THE PREPARATION, IT WAS FOUND THAT THE STENT WAS FRACTURED. 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 24739197 ↗MalfunctionFeb 25, 2026Material Split, Cut or Torn
IT WAS REPORTED THAT A PERCUFLEX PLUS URETERAL STENT WAS USED IN A URETEROSCOPIC STENT PLACEMENT IN THE URETER. DURING THE PROCEDURE AND INSIDE THE PATIENT, IT WAS NOTICED THAT THE END OF THE STENT (LOOP) WAS TORN. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24439442 ↗MalfunctionFeb 13, 2026Break; Nonstandard Device
IT WAS REPORTED THAT A PERCUFLEX PLUS URETERAL STENT WAS TO BE USED IN A STENT IMPLANTATION PROCEDURE. DURING UNPACKING, IT WAS FOUND THAT THE STENT WAS FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER SAME DEVICE AND THERE WERE NO PATIENT COMPLICATIONS REPORTED. A PHOTO OF THE COMPLAINT DEVICE WAS PROVIDED AND SHOWED THAT THE STENT SHAFT WAS FRACTURED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24333901 ↗MalfunctionFeb 6, 2026Nonstandard Device; Deformation Due to Compressive Stress; Material Integrity Problem; Material Split, Cut or Torn
IT WAS REPORTED THAT A PERCUFLEX PLUS URETERAL STENT WAS USED IN A RETROGRADE INTRARENAL SURGERY PROCEDURE IN THE LEFT URETER. DURING THE PROCEDURE, WHEN THE STENT WAS PUSHED THROUGH THE GUIDEWIRE, IT COULD NOT BE SEEN UNDER THE FLUOROSCOPY. THE PHYSICIAN ATTEMPTED TO REPOSITION THE STENT, HOWEVER, ONLY THE GUIDEWIRE CAN BE SEEN UNDER FLUOROSCOPY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE AND THERE WERE NO PATIENT COMPLICATIONS REPORTED. THIS EVENT HAS BEEN DEEMED REPORTABLE BASED ON THE INVESTIGATION FINDING THAT THE STENT WAS TORN AND BUCKLED INSIDE THE PATIENT. PLEASE SEE BLOCK H11 FOR FULL INVESTIGATION DETAILS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24284824 ↗MalfunctionFeb 3, 2026Break
IT WAS REPORTED THAT A PERCUFLEX PLUS URETERAL STENT WAS TO BE USED IN A LITHOTRIPSY PROCEDURE. DURING UNPACKING, IT WAS FOUND THAT THE STENT WAS BROKEN. THE PROCEDURE WAS COMPLETED WITH ANOTHER SAME DEVICE AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24247322 ↗
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Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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