ProACT - Implantation Instrument Set 750041Recalls & reported problems
Uromedica Inc · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00180668000106), received between Jul 23, 2020 and Oct 11, 2023 — classified as 5 injuries.
The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (4 reports).
1 FDA recall record name this device's identifier.
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.
Reports received per month
Recalls naming this device
- Nov 22, 2021Class IITerminated
The U-channel sheaths may cause damage to ProACT implant devices when the devices are passed through the sheath during a ProACT implantation procedure.
Z-0458-2022 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗
Most reported problems
Device problems
- Improper or Incorrect Procedure or Method4
- Use of Device Problem1
Patient problems
- Internal Organ Perforation5
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjuryOct 11, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method
BOTH BALLOONS WERE PLACED BUT DR. ART OPTED TO PLACE THE LEFT BALLOON MORE MEDIAL THAN ORIGINAL DEPLOYMENT TO THE URETHRA. UPON SUBSEQUENT FLUOROSCOPY, IT WAS NOTICED THAT THE BLADDER WITH CONTRAST WAS DEFLATING. A SMALL URETHRAL PERFORATION WAS IDENTIFIED AT THE 3 O CLOCK POSITION. THIS WOULD HAVE OCCURRED WITH THE SHARP TROCAR OR OPEN U-CHANNEL. THE LEFT SIDE WAS ABORTED AND THE DEVICE WAS NOT PLACED. THE RIGHT SIDE WAS LEFT IN PLACE. REVISION LEFT SIDE SCHEDULED FOR (B)(6) 2023.
Patient problems: Internal Organ Perforation
MAUDE report 17916219 ↗InjuryDec 21, 2021Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method
INTEROPERATIVE URETHRAL PERFORATION IN A PROACT PATIENT.
Patient problems: Internal Organ Perforation
MAUDE report 13054388 ↗InjurySep 9, 2021Use of Device Problem; Use of Device Problem
BLADDER PERFORATION IN A MALE PATIENT DURING A PROACT REVISION PROCEDURE. THE PATIENT'S LEFT-SIDE PROACT WAS IMPLANTED WITHOUT INCIDENT, BUT THE PATIENT'S BLADDER WAS PERFORATED WITH THE SHARP-TIPPED TROCAR DURING DILATION FOR THE PATIENT'S RIGHT SIDE PROACT. PATIENT SENT HOME WITH CATHETER.
Patient problems: Internal Organ Perforation
MAUDE report 12446446 ↗InjuryAug 2, 2021Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method
URETHRAL PERFORATION AT THE BLADDER NECK IN A PROACT PATIENT DURING IMPLANT. PATIENT SUCCESSFULLY IMPLANTED. PROACT BALLOONS PLACED AT THE APEX OF THE PROSTATE RATHER THAN THE BLADDER NECK, THE ORIGINAL INTENDED LOCATION. PERFORATION TREATED VIA CATHETERIZATION.
Patient problems: Internal Organ Perforation
MAUDE report 12263341 ↗InjuryJul 23, 2020Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method
THE PATIENT'S BLADDER NECK WAS PERFORATED BY AN IMPLANTATION INSTRUMENT (TROCAR) DURING A PROACT IMPLANTATION PROCEDURE. IMPLANTATION PROCEDURE WAS ABORTED. A CATHETER WAS PLACED IN THE PATIENT AND WILL REMAIN FOR 10-14 DAYS. THE PATIENT WAS PUT ON ANTIBIOTICS. THE PATIENT WILL BE IMPLANTED WITH PROACT WHEN THE TISSUES HAVE HEALED. THE INITIAL REPORTER'S RESIDENT WAS PERFORMING THE PROACT PROCEDURE AND PERFORATED THE BLADDER NECK. THE INITIAL REPORTER STATED THAT SURGICAL ERROR WAS THE CAUSE OF THE ADVERSE EVENT.
Patient problems: Internal Organ Perforation
MAUDE report 10316066 ↗
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 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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