ProACT Adjustable Continence Therapy for Men – 14 cm Implants - Patient Pack 800018-14Recalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 00180668000380), received between Nov 16, 2018 and Jun 23, 2026 — classified as 31 injuries.

The most frequently reported specific device problem is “Migration” (8 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 31 reports, in the reporter's own words as published by the FDA.

• InjuryJun 23, 2026Adverse Event Without Identified Device or Use Problem

  A URETHRAL STRICTURE OCCURRED SUBSEQUENT TO A (PREVIOUSLY REPORTED) PROACT DEVICE EROSION AND EXPLANTATION. THE URETHRAL STRICTURE DEVELOPED WHERE THE PROACT DEVICE HAD PREVIOUSLY ERODED (REPORTED IN 3003477176-2025-00019-00507). SPECIFICALLY, A 15 FRENCH STENOSIS WAS NOTED AT THE VESICOURETHRAL ANASTOMOSIS. IT WAS RESOLVED VIA DILATION OF THE BLADDER NECK TO 20 FRENCH, WITH NO RESIDUAL EFFECTS. THE PATIENT HAD THE PROACT DEVICE EXPLANTED FOR AT LEAST FOUR MONTHS SINCE THE DATE OF ONSET. THE EVENT WAS SPECIFIED AS RELATED TO THE DEVICE, BUT NOT THE PROCEDURE.

  Patient problems: Urethral Stenosis/Stricture

  MAUDE report 25592347 ↗
• InjuryJun 8, 2026Adverse Event Without Identified Device or Use Problem

  BILATERAL PLACEMENT OF PROACT DEVICES PERFORMED APPROXIMATELY 1 MONTH PRIOR TO EVENT. ADEQUATE PLACEMENT WAS CONFIRMED BY CYSTOSCOPY AND FLUOROSCOPY (VERIFIED VIA IMAGING - ATTACHED TO THIS REPORT). ON EVENT DATE, PATIENT CAME INTO OFFICE AND A BALLOON EROSION WAS IDENTIFIED VIA CYSTOSCOPY. BOTH DEVICES WERE REMOVED. REPLACEMENT OF THE DEVICES IS NOT PLANNED.

  Patient problems: Erosion

  MAUDE report 25431551 ↗
• InjuryMay 18, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT UNDERWENT A UNILATERAL EXPLANATION OF A PROACT DEVICE IN (B)(6) 2026. THE PATIENT'S RIGHT BALLOON WAS EXPLANTED AT THE SCROTUM IN A SUPINE POSITION. LOCAL ANESTHETIC WAS GIVEN PRIOR TO INCISION. A CENTIMETER INCISION WAS MADE AT THE SCROTAL SKIN WHERE THE DEVICE PORT WAS LOCATED. THE INCISION WAS WIPED WITH CULTURE SWABS FOR FURTHER ANALYSIS. THE DEVICE WAS ASPIRATED WITH 4CC OF FLUID, DEFLATED, AND EXPLANTED. THE DEVICE REMAINED INTACT WHEN REMOVED. THE BALLOON WAS TESTED ON THE BACK TABLE USING A 23G HYPO NEEDLE AND A SYRINGE FILLED WITH THE ASPIRATED MIXTURE. THERE WAS NO LEAKAGE OR KNOWN PERFORATION. THE PATIENT COMPLAINED ABOUT PAIN AROUND THE SCROTAL AREA. NO ERYTHEMA. INFECTION WAS DISCOVERED AT TIME OF INCISION.

  Patient problems: Implant Pain; Medical device site infection

  MAUDE report 25201448 ↗
• InjuryMay 4, 2026Material Rupture; Migration

  PATIENT WAS USING PERINEAL VIBRATION DEVICE FOR ERECTILE DYSFUNCTION FOR 10 MINUTES. HE NOTED SUDDEN ONSET URINARY LEAKAGE. A PELVIC X-RAY IN (B)(6) 2026 SHOWED A RIGHT BALLOON RUPTURE AND LEFT BALLOON MIGRATION. PATIENT UNDERWENT BILATERAL PROACT BALLOON EXPLANT AND REPLACEMENT IN (B)(6) 2026. THE CAUSE STATED BY THE REPORTER IS THE PERINEAL VIBRATION DEVICE. THERE WAS STATED TO BE A DEVICE AND PROCEDURE RELATIONSHIP TO THE EVENT. THE ISSUE WAS RESOLVED WITH THE BILATERAL EXPLANT AND REVISION OF THE BALLOONS WITH NO RESIDUAL EFFECTS.

  Patient problems: Urinary Incontinence

  MAUDE report 25069100 ↗
• InjuryApr 23, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT UNDERWENT A BILATERAL IMPLANTATION OF A PROACT DEVICE (DATE UNKNOWN). PATIENT'S RIGHT DEVICE SUBSEQUENTLY BECAME INFECTED POST-PROCEDURE. ONSET DATE OF INFECTION IS UNKNOWN. SURGICAL INTERVENTION WAS REQUIRED, INCLUDING AN EXPLANATION OF RIGHT PROACT DEVICE AND IRRIGATION OF THE IMPLANT SITE. DEVICE REMAINED INTACT WHEN REMOVED. THERE WERE NO KNOWN EFFECTS TO THE PATIENT.

  Patient problems: Medical device site infection

  MAUDE report 24968910 ↗
• InjuryMar 6, 2026Expulsion

  PATIENT PREVIOUSLY UNDERWENT BILATERAL IMPLANTATION OF PROACT (DATE UNKNOWN, 2025). PATIENT ACHIEVED CONTINENCE. THEN, THE PORT OF ONE PROACT DEVICE ERODED THROUGH SKIN OF THE PATIENT'S SCROTUM. THE DEVICE WAS DEEMED INFECTED. THE DEVICE WAS EXPLANTED UNDER ANESTHESIA. CYSTOSCOPY WAS PERFORMED AND INDICATED NO OTHER INJURIES TO THE PATIENT.

  Patient problems: Medical device site infection; Pocket Erosion

  MAUDE report 24532150 ↗
• InjuryMar 5, 2026Migration

  THE PATIENT CONTACTED THE CLINIC ON (B)(6) 2025 REPORTING RETURN OF INCONTINENCE AND DIFFICULTY VOIDING FOR A COUPLE OF DAYS PRIOR TO THE INCONTINENCE. X-RAY AND CT CONFIRMED A LEFT BALLOON MIGRATION INTO THE BLADDER. EXPLANT PERFORMED ON (B)(6) 2026.

  Patient problems: Dysuria; Urinary Incontinence

  MAUDE report 24524379 ↗
• InjuryJan 2, 2026Difficult or Delayed Positioning

  BLADDER PERFORATION ON PATIENT'S LEFT SIDE. BALLOON WAS REPOSITIONED MORE DISTAL AND PLACED. DOCTOR LEFT A CATHETER AND REMOVED IT THREE DAYS AFTER IMPLANTATION. PATIENT'S RIGHT SIDE WAS PLACED NORMALLY. PATIENT WAS IRRADIATED.

  Patient problems: Internal Organ Perforation

  MAUDE report 23944368 ↗
• InjuryDec 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT UNDERWENT BI-LATERAL IMPLANTATION OF PROACT. PATIENT HAD PREVIOUS BLADDER NECK CONTRACTURE AND RADIATION THERAPY. PATIENT WAS IN RETENTION AFTER A CYSTOSCOPY ONE WEEK PRIOR TO THE PROACT PROCEDURE. EACH DEVICE HAD 1CC FLUID. URETHRA WAS CLOSED SHUT DURING POST-OP CYSTOSCOPY. ONE WEEK LATER, PATIENT WAS IN RETENTION. DEVICES WERE FULLY DEFLATED AND STILL IN RETENTION. THEN, PATIENT HAD GROSS HEMATURIA, SUSPICIOUS FOR AN ERODED DEVICE. PATIENT CAME BACK TO OR FOR CYSTOSCOPY AND TO ADDRESS RECURRING BLADDER NECK CONTRACTURE. PATIENT LEFT DEVICE WAS ERODED AND REMOVED. PATIENT RIGHT DEVICE WAS REINFLATED TO 0.5CC,AND THEN CYSTOSCOPY SHOWED EROSION, SO THAT WAS REMOVED TOO. PATIENT SENT HOME WITH A FOLEY.

  Patient problems: Erosion; Hematuria; Urinary Retention

  MAUDE report 23872015 ↗
• InjurySep 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT CAME IN FOR FIRST ADJUSTMENT (VISIT WAS IN THE LAST 2 WEEKS). PATIENT COMPLAINED OF SOME PAIN AND DISCOMFORT WHEN SITTING DOWN. ON PHYSICAL EXAM, INFECTION WAS IDENTIFIED IN THE PERINEUM AND SCROTUM. DOCTOR ATTEMPTED ANTIBIOTIC REGIMENT TO DEAL WITH INFECTION. THE INFECTION DID NOT SUBSIDE AFTER ANTIBIOTICS AND BOTH DEVICES WERE EXPLANTED. NO EROSION WAS NOTED. PATIENT IS DECIDING WHETHER THEY WANT TO BE REIMPLANTED OR NOT NOW.

  Patient problems: Implant Pain; Skin Infection

  MAUDE report 23100460 ↗
• InjurySep 19, 2025Difficult or Delayed Positioning; Difficult or Delayed Positioning

  BLADDER PERFORATION ON PATIENT'S LEFT SIDE. CONTRAST WAS SEEN COMING OUT OF THE SHEATH. TROCAR WAS REPOSITIONED AND BALLOON WAS DELIVERED. DEVICE WAS NOT SEEN ON CYSTOSCOPY AND POSITIONING WAS GOOD. BOTH DEVICES WERE DELIVERED AND PLACEMENT WAS SATISFACTORY. PATIENT WAS SENT HOME WITH A CATHETER FOR 5-7 DAYS. NEOBLADDER PATIENT (POST-CYSTECTOMY AND PROSTATECTOMY).

  Patient problems: Internal Organ Perforation

  MAUDE report 23097482 ↗
• InjurySep 19, 2025Difficult or Delayed Positioning; Difficult or Delayed Positioning

  BLADDER PERFORATION ON PATIENT'S LEFT SIDE. CONTRAST WAS SEEN COMING OUT OF THE SHEATH. TROCAR WAS REPOSITIONED AND BALLOON WAS DELIVERED. THE BALLOON WAS SEEN ON THE CYSTOSCOPY IN THE PATIENT'S URETHRA AT THE BLADDER NECK. DEVICE WAS REMOVED AND TROCAR WAS REPOSITIONED MORE DISTALLY. BOTH DEVICES WERE DELIVERED AND DEVICES WERE NOT SEEN ON CYSTOSCOPY. PATIENT WAS SENT HOME WITH A CATHETER FOR 5-7 DAYS. POST-RALP PATIENT WITH RADIATION.

  Patient problems: Internal Organ Perforation

  MAUDE report 23097481 ↗
• InjurySep 18, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  ABNORMAL, EXCESSIVE BLEEDING ON PATIENT FROM BOTH INCISION SITES. THE BLOOD WAS RUNNING OUT OF THE SHEATH EXCESSIVELY WHEN THE TROCAR WAS REMOVED ON BOTH SIDES. AFTER THE DEVICES WERE PLACED, THE INCISION SITES CONTINUED TO SEEP BLOOD AT A HIGHER-THAN-NORMAL RATE. THE DOCTOR ATTEMPTED CAUTERY OF NEAR THE INCISION SITE FOR TO STOP ONE OF THE SOURCES OF THE BLEEDING. THE DOCTOR APPLIED PRESSURE FOR 15-20 MINUTES TO STOP THE BLEEDING. THE BLEEDING STOPPED ON ONE INCISION BUT CONTINUED SLOWLY ON THE CONTRALATERAL SIDE. THE DOCTOR PACKED THE WOUND WITH STERICEL AND CLOSED THE INCISION. THE DOCTOR AND REP WERE NOT ABLE TO IDENTIFY OR THEORIZE THE SOURCE OF THE BLEEDING. CYSTOSCOPY WAS CLEAR, NO PERFORATIONS OCCURRED. THE BLADDER STILL FULLY HELD ALL CONTRAST AND NO HEMATURIA WAS IDENTIFIED. NO NEGATIVE PATIENT EFFECTS ASSOCIATED WITH THE BLEEDING WERE NOTED. NOTHING ABNORMAL WAS REPORTED POST-OPERATIVELY. POST-RALP PATIENT. PATIENT REPORTED STOPPING LOW-DOSE ASPIRIN 7 DAYS BEFORE PROCEDURE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23091427 ↗
• InjuryJul 8, 2025Unintended Movement; Migration; Unintended Movement; Migration

  PATIENT HAD MULTIPLE PORT EROSIONS IN THE PERINEUM. DOCTOR ATTEMPTED TO SALVAGE IN THE OR AT LEAST TWICE BY MOVING THE PORTS AND RE-CLOSING THE INCISIONS. THE PATIENT HAS NOW BEEN EXPLANTED.

  Patient problems: Erosion

  MAUDE report 22436436 ↗
• InjuryApr 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS SEEN FOR URINARY RETENTION. STRAIGHT CATH COMPLETED. RETURNED TO THE ER LATER AND CBI WAS COMPLETED. FOLEY CATH PLACED.

  Patient problems: Urinary Retention

  MAUDE report 21750967 ↗
• InjuryMar 21, 2025Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  PATIENT PHONED INTO THE CLINIC WITH PAIN ON LEFT TESTICLE AND FEELING SOME "CORDS" IN THE SCROTUM.

  Patient problems: Discomfort; Implant Pain

  MAUDE report 21663365 ↗
• InjuryJan 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WENT INTO RETENTION AFTER THE FIRST VOLUME ADJUSTMENT. 0.5CC WERE REMOVED AND THE PATIENT WAS STILL IN RETENTION. PRESUMABLY, ADDITIONAL VOLUME WAS REMOVED TO RESOLVE THE RETENTION, BUT UROMEDICA WAS NOT EXPLICITLY INFORMED OF THIS. THE PATIENT WAS LATER HOSPITALIZED FOR SEPSIS, IT IS UNCLEAR IF THIS IS RELATED TO UROMEDICA'S DEVICE OR PROCEDURE. THE PATIENT WAS LEAKING AT THE NEXT OFFICE VISIT. IT IS NOT CURRENTLY CLEAR IN WHAT ORDER SEPSIS AND THE LATEST OFFICE VISIT OCCURRED.

  Patient problems: Incontinence; Sepsis; Urinary Retention

  MAUDE report 21228852 ↗
• InjurySep 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  GROSS HEMATURIA. BEGAN PASSING CLOTS ON (B)(6). STRAIGHT CATH IN ER. HOURS LATER RETURNED TO ER WHERE CBI COMPLETED AND FOLEY CATH PLACED.

  Patient problems: Hematuria

  MAUDE report 20296971 ↗
• InjuryNov 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INCISION BLEED WITH SLIGHT WOUND DEHISCENCE AND LOCALIZED AREAS OF INDURATION AT BOTH INCISION SITES IN A PROACT PATIENT. THE ISSUE WAS RESOLVED WITH MEDICATION AND NO RESIDUAL SIDE-EFFECTS.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Inflammation; Wound Dehiscence

  MAUDE report 15818792 ↗
• InjuryAug 25, 2022Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  INFECTION IN A PROACT PATIENT, NECESSITATING BILATERAL EXPLANT.

  Patient problems: Unspecified Infection

  MAUDE report 15298440 ↗
• InjuryMay 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  POSTOPERATIVE ACUTE URINARY RETENTION IN A PROACT PATIENT. THE PATIENT EXPERIENCED RETENTION SYMPTOMS IN THE MORNING FOLLOWING HIS PROACT IMPLANATION PROCEDURE. THE IMPLANTING PHYSICIAN REMOVED 0.5ML FROM EACH PROACT BALLOON AND THE PATIENT WAS ABLE TO VOID WITH NO ISSUES.

  Patient problems: Urinary Retention

  MAUDE report 14347883 ↗
• InjuryMar 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  URINARY RETENTION IN A PROACT PATIENT DUE TO SURGICAL SWELLING IN THE TREATMENT AREA. THE RETENTION OCCURED AFTER THE PATIENT WAS DISCHARGED. THE PATIENT RETURNED FOR MEDICAL INTERVENTION AND WAS CATHETERIZED UNTIL THE SWELLING SUBSIDED. THE URINARY RETENTION HAS SINCE BEEN RESOLVED AND THE PATIENT IS URINATING WELL WITHOUT CATHETERIZATION.

  Patient problems: Urinary Retention

  MAUDE report 13801261 ↗
• InjuryFeb 4, 2022Migration; Migration

  BLADDER EROSION (LEFT-SIDE) IN A PROACT PATIENT. THE PATIENT WAS UNILATERALLY EXPLANTED.

  Patient problems: Erosion

  MAUDE report 13457879 ↗
• InjurySep 24, 2021Migration or Expulsion of Device; Migration or Expulsion of Device

  SCROTAL PORT EROSION THROUGH THE SKIN (SIDE UNSPECIFIED) IN A PROACT PATIENT.

  Patient problems: Erosion

  MAUDE report 12529797 ↗
• InjuryFeb 12, 2021Fluid/Blood Leak; Device Damaged by Another Device; Migration; Material Split, Cut or Torn; Fluid/Blood Leak; Device Damaged by Another Device; Migration; Material Split, Cut or Torn

  INFECTION IN A PROACT PATIENT. INFECTION WAS TREATED WITH ANTIBIOTICS AND RESOLVED.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 11324142 ↗