Bulkamid 50050 (UDI 10810005340509)Recalls & reported problems
Axonics Modulation Technologies, Inc. · Bulkamid Urethral Bulking System 2mL · Class 3 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Bulkamid Urethral Bulking System is an injectable gel implant used in urology to help with urinary leakage. Most of the 32 reports describe difficulty emptying the bladder or continued leakage after the injection, along with burning or pain when urinating, and some skin irritation. A few mention material leaking from the syringe during the procedure when the needle connection gave way, and one describes a hematoma near the urethra. There is 1 death and 28 injuries reported. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 32
- Deaths reported
- 1
- Injuries reported
- 28
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 10810005340509), received between Feb 16, 2024 and Aug 20, 2026 — classified as 1 death, 28 injuries, 3 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (3 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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem25
- Fluid/Blood Leak3
- Insufficient Device Problem Information3
- Appropriate Device Problem Term/Code Not Available2
- Incomplete or Inadequate Connection2
- Obstruction of Flow2
Patient problems
- Incontinence14
- Urinary Retention14
- Rash5
- Hematoma4
- Hypersensitivity/Allergic reaction4
- Itching Sensation4
- No Clinical Signs, Symptoms or Conditions3
- Pain3
Recent adverse event reports
The 25 most recent of 32 reports, in the reporter's own words as published by the FDA.
InjuryAug 20, 2026Adverse Event Without Identified Device or Use Problem
It was reported that a patient who underwent Bulkamid placement procedure, had developed pain in the urethra three weeks after, the physician has decided to treat him with antibiotics due to suspected infection. The issue was reported as ongoing.
Patient problems: Discomfort; Pain; Unspecified Infection
MAUDE report 50354615 ↗MalfunctionMar 30, 2026Fluid/Blood Leak; Obstruction of Flow; Incomplete or Inadequate Connection
IT WAS REPORTED THAT DURING THE BULKAMID INJECTION, THE CLINICAL TEAM ENCOUNTERED RESISTANCE WHILE ATTEMPTING TO ADVANCE THE BULKING MATERIAL THROUGH THE NEEDLE. DURING THIS PROCESS, A LEAK OF MATERIAL WAS OBSERVED DUE TO A FAILURE OF THE LUER-LOCK CONNECTION BETWEEN THE NEEDLE AND THE SYRINGE. THE PHYSICIAN WAS ABLE TO DELIVER APPROXIMATELY ONE FULL TUBE OF MATERIAL. ALTHOUGH PARTIAL DELIVERY WAS ACHIEVED, THE TREATMENT WAS NOT CONSIDERED OPTIMAL. ACCORDING TO THE PHYSICIAN, TWO DEVICES EXHIBITED THE ISSUE. THE PATIENT WAS UNDER GENERAL ANESTHESIA AT THE TIME OF THE PROCEDURE. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED IN ASSOCIATION WITH THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24715810 ↗MalfunctionMar 30, 2026Fluid/Blood Leak; Obstruction of Flow; Incomplete or Inadequate Connection
IT WAS REPORTED THAT DURING THE BULK AMID INJECTION, THE CLINICAL TEAM ENCOUNTERED RESISTANCE WHILE ATTEMPTING TO ADVANCE THE BULKING MATERIAL THROUGH THE NEEDLE. DURING THIS PROCESS, A LEAK OF MATERIAL WAS OBSERVED DUE TO A FAILURE OF THE LUER-LOCK CONNECTION BETWEEN THE NEEDLE AND THE SYRINGE. THE PHYSICIAN WAS ABLE TO DELIVER APPROXIMATELY ONE FULL TUBE OF MATERIAL. ALTHOUGH PARTIAL DELIVERY WAS ACHIEVED, THE TREATMENT WAS NOT CONSIDERED OPTIMAL. ACCORDING TO THE PHYSICIAN, TWO DEVICES EXHIBITED THE ISSUE. THE PATIENT WAS UNDER GENERAL ANESTHESIA AT THE TIME OF THE PROCEDURE. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED IN ASSOCIATION WITH THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24713348 ↗InjuryMar 26, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT WHO UNDERWENT BULKAMID IMPLANTATION, REPORTED HAVING RETENTION AND VAGINAL BLEEDING. SHE WAS SEEN BY ANOTHER PHYSICIAN DUE TO THE RETENTION, AND IT WAS DETERMINED THAT THERE WAS A LARGE HEMATOMA BETWEEN THE URETHRA AND THE VAGINA. THE PATIENT HAD A CATHETER PLACED. THE ISSUE WAS REPORTED AS ONGOING.
Patient problems: Hematoma; Hemorrhage/Blood Loss/Bleeding; Urinary Retention
MAUDE report 24702032 ↗MalfunctionMar 11, 2026Fluid/Blood Leak
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A BULKAMID WAS USED DURING A PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THERE WAS A LEAK FROM THE SYRINGE. IT WAS REPORTED AS AN UNSUCCESSFUL IMPLANT. THE TYPE OF ANESTHESIA UTILIZED WAS NOT REPORTED. BOSTON SCIENTIFIC CORPORATION HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THIS EVENT, DESPITE GOOD FAITH EFFORTS. THERE WERE NO PATIENT COMPLICATIONS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24570743 ↗InjuryDec 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A BULKAMID PROCEDURE WAS PERFORMED ON (B)(6) 2025, WITHOUT COMPLICATIONS. HOWEVER, IT WAS REPORTED THAT THE PATIENT WENT TO THE EMERGENCY ROOM DUE TO BURNING AND PAIN SENSATION DURING URINATION. THE PATIENT WAS TREATED WITH ANTIBIOTICS AND WAS RELEASED. THE PATIENT DID COMPLAIN THAT THIS WAS AN ISSUE BEFORE HER PROCEDURE.
Patient problems: Burning Sensation; Discomfort; Pain
MAUDE report 23846508 ↗InjuryAug 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT RECEIVED BULKAMID URETHRAL BULKING SYSTEM SOMETIME IN (B)(6) 2025. FOLLOWING THE PROCEDURE, THE PATIENT EXPERIENCED URINARY RETENTION AND REQUIRED CLEAN INTERMITTENT CATHETERIZATION (CIC) FOR THREE DAYS. SHE CONTINUED TO EXPERIENCE DIFFICULTY EMPTYING HER BLADDER, WITH ELEVATED POST-VOID RESIDUAL (PVR) VOLUMES, ALTHOUGH SPECIFIC MEASUREMENTS WERE NOT AVAILABLE. ADDITIONALLY, THE PATIENT REPORTED A WORSENING OF HER STRESS URINARY INCONTINENCE (SUI) COMPARED TO HER CONDITION PRIOR TO THE PROCEDURE. AS OF THE TIME OF THIS REPORT, IT IS UNKNOWN WHETHER THE PATIENT'S SYMPTOMS HAVE RESOLVED. BOSTON SCIENTIFIC CORPORATION HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THIS EVENT, DESPITE GOOD FAITH EFFORTS.
Patient problems: Urinary Incontinence; Urinary Retention
MAUDE report 22873539 ↗InjuryMay 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT WAS CATHETERIZED DUE TO URINARY RETENTION.
Patient problems: Incontinence; Urinary Retention
MAUDE report 22096295 ↗InjuryMay 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT WAS CATHETERIZED DUE TO URINARY RETENTION.
Patient problems: Incontinence; Urinary Retention
MAUDE report 22095688 ↗InjuryMay 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT WAS CATHETERIZED DUE TO URINARY RETENTION.
Patient problems: Incontinence; Urinary Retention
MAUDE report 22095666 ↗InjuryMay 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT WAS CATHETERIZED DUE TO URINARY RETENTION.
Patient problems: Incontinence; Urinary Retention
MAUDE report 22092611 ↗InjuryMay 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
SEE SECTION H, NUMBER 6 FOR INVESTIGATION UPDATES.
Patient problems: Incontinence; Urinary Retention
MAUDE report 21947078 ↗InjuryApr 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT WAS HOSPITALIZED DUE TO A REACTION.
Patient problems: Incontinence; Pain
MAUDE report 21914877 ↗InjuryJan 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT WAS PRESCRIBED MEDICATION DUE TO A RASH.
Patient problems: Incontinence; Rash
MAUDE report 21087927 ↗InjuryDec 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT WAS HOSPITALIZED DUE TO URINARY RETENTION, HEMATOMA, AND VAGINAL FISTULA.
Patient problems: Fistula; Hematoma; Incontinence; Urinary Retention
MAUDE report 20920867 ↗InjuryOct 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT UNDERWENT EXPLANT SURGERY DUE TO URINARY RETENTION.
Patient problems: Incontinence; Urinary Retention
MAUDE report 20494918 ↗InjurySep 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT UNDERWENT BULKAMID CUSHION EXCISION DUE TO IMPLANT PAIN.
Patient problems: Implant Pain; Incontinence
MAUDE report 20328003 ↗InjurySep 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT HAD A RESECTION DUE TO HEMATURIA.
Patient problems: Hematuria; Incontinence
MAUDE report 20263387 ↗InjuryJul 15, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
THE PATIENT DEVELOPED DYSURIA AND A LESION.
Patient problems: Calcium Deposits/Calcification; Dysuria; Incontinence; Inflammation
MAUDE report 19742021 ↗InjuryJul 15, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
THE PATIENT WAS CATHETERIZED FOR URINARY RETENTION AND PRESCRIBED ANTIBIOTICS DUE TO AN ABSCESS.
Patient problems: Abscess; Incontinence; Urinary Retention; Urinary Tract Infection
MAUDE report 19741984 ↗InjuryJul 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT RECEIVED SELF-CATHETERIZATION DUE TO URINARY RETENTION AND ANTIBIOTICS DUE TO AN ABSCESS.
Patient problems: Urinary Retention
MAUDE report 19712793 ↗InjuryJun 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT REPORTED THAT THEY DEVELOPED A BLADDER STONE AND A FISTULA.
Patient problems: Incontinence; Urolithiasis
MAUDE report 19521814 ↗InjuryMay 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT RECEIVED A MEDICAL INTERVENTION TO TREAT URINARY RETENTION AND HEMATOMA.
Patient problems: Hematoma; Urinary Retention
MAUDE report 19274876 ↗InjuryApr 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT EXPERIENCED URINARY TRACT INFECTION AND URINARY INCONTINENCE.
Patient problems: Urinary Incontinence; Urinary Tract Infection
MAUDE report 19101581 ↗InjuryApr 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
SEE SECTION H, NUMBER 6 FOR INVESTIGATION UPDATES.
Patient problems: Hypersensitivity/Allergic reaction; Itching Sensation; Rash
MAUDE report 19091582 ↗
Other Agent, Bulking, Injectable For Gastro-Urology Use devices
- Deflux Gel 1.0 mL SyringePalette Life Sciences, Inc. · Agent, Bulking, Injectable For Gastro-Urology Use63 reports
- Macroplastique Implants MPQ-2.5Uroplasty, Inc. · Agent, Bulking, Injectable For Gastro-Urology Use12 reports
- Bulkamid 50050Contura International A/S · Agent, Bulking, Injectable For Gastro-Urology Use9 reports
- Solesta Gel 1.0 mL SyringePalette Life Sciences, Inc. · Agent, Bulking, Injectable For Gastro-Urology Use6 reports
- Deflux Metal Needle 3.7 FR x 23 G (tip) x 350 mmPalette Life Sciences, Inc. · Agent, Bulking, Injectable For Gastro-Urology Use1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- 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.
How reports and recalls are matched · Editorial policy · Report an error on this page