Urovac Bladder Evacuator M0067301250Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 08714729753018), received between Feb 21, 2018 and Nov 21, 2025 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (6 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 21, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A UROVAC BLADDER EVACUATOR DEVICE WAS SET TO BE USE DURING A PROCEDURE. REPORTEDLY, IT WAS NOTICED THAT A HAIR WAS FOUND INSIDE OF THE STERILE PACKAGING. NO PATIENT INVOLVEMENT OR HARM OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23616187 ↗
• MalfunctionSep 4, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT A UROVAC DEVICE WAS USED DURING A PROCEDURE. REPORTEDLY, IT WAS NOTICED THAT A FOREIGN MATTER WAS MIXED IN. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE WITH NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22962258 ↗
• MalfunctionMay 5, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT A UROVAC DEVICE WAS ABOUT TO BE USED DURING TURP (TRANSURETHRAL RESECTION OF THE PROSTATE) PROCEDURE. REPORTEDLY, UPON OPENING THE PACKAGING THEY SAW A BLACK FLECKS INSIDE THREE UROVACS. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE WITH NO PATIENT COMPLICATIONS. THIS REPORT PERTAINS TO THE THIRD OF THREE UROVAC DEVICES USED IN THE SAME PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21965104 ↗
• MalfunctionMay 5, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT A UROVAC DEVICE WAS ABOUT TO BE USED DURING TURP (TRANSURETHRAL RESECTION OF THE PROSTATE) PROCEDURE. REPORTEDLY, UPON OPENING THE PACKAGING THEY SAW A BLACK FLECKS INSIDE THREE UROVACS. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE WITH NO PATIENT COMPLICATIONS. THIS REPORT PERTAINS TO THE SECOND OF THREE UROVAC DEVICES USED IN THE SAME PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21965103 ↗
• MalfunctionMay 5, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT A UROVAC DEVICE WAS ABOUT TO BE USED DURING TURP (TRANSURETHRAL RESECTION OF THE PROSTATE) PROCEDURE. REPORTEDLY, UPON OPENING THE PACKAGING THEY SAW A BLACK FLECKS INSIDE 3 UROVACS. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE WITH NO PATIENT COMPLICATIONS. THIS REPORT PERTAINS TO THE FIRST OF THREE UROVAC DEVICES USED IN THE SAME PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21961805 ↗
• MalfunctionJul 16, 2020Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A UROVAC BLADDER EVACUATOR WAS UNPACKED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, DURING THE PREPARATION, A FOREIGN OBJECT WAS FOUND INSIDE THE DEVICE. THE PROCEDURE WAS COMPLETED WITH ANOTHER UROVAC BLADDER EVACUATOR DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10282960 ↗
• MalfunctionJan 29, 2020Contamination; Packaging Problem; Contamination; Packaging Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A UROVAC BLADDER EVACUATOR WAS UNPACKED FOR TRANSURETHRAL RESECTION OF THE PROSTATE (TURP) ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, THE PACKAGING OF THE DEVICE WAS COMPROMISED. PHOTOS SENT IN BY THE CUSTOMER CONFIRMED THE INDENTATIONS IN THE PACKAGING. THIS WAS FOUND PRIOR TO USE WITH A PATIENT OR PROCEDURE.

  Patient problems: No Patient Involvement

  MAUDE report 9641380 ↗
• MalfunctionApr 25, 2018Device Packaging Compromised; Device Packaging Compromised

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A BLADDER EVACUATOR DEVICE WAS UNPACKED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING UNPACKING, THE PACKAGING OF THE DEVICE WAS NOTED TO BE DAMAGED. IT WAS NOTICED THAT THE PACKAGING HAS A CUT. REPORTEDLY, THIS WAS NOT USED IN A PATIENT. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED DUE TO THIS EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 7462373 ↗
• MalfunctionMar 21, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A UROVAC BLADDER EVACUATOR WAS UNPACKED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING UNPACKING, A FOREIGN BODY WAS NOTED ON THE DEVICE. IT WAS REPORTED THAT THE STERILE PACKAGING WAS COMPLETELY SEALED AND NO DAMAGES WERE NOTED ON THE OUTER PACKAGING. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7356805 ↗
• MalfunctionFeb 21, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A UROVAC BLADDER EVACUATOR WAS USED IN A PROCEDURE ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, A YELLOW STAIN WAS NOTED ON THE PRODUCT. ATTEMPTS TO OBTAIN ADDITIONAL PATIENT AND PROCEDURE INFORMATION HAVE BEEN UNSUCCESSFUL. IF ANY FURTHER RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL MDR WILL BE FILED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7285667 ↗