BioProtect Balloon Implant™ System 5135Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 07290014878020), received between Feb 26, 2026 and Sep 13, 2026 — classified as 7 injuries.

The most frequently reported specific device problem is “Difficult or Delayed Positioning” (2 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjurySep 13, 2026Difficult or Delayed Positioning

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Urinary Retention

  MAUDE report 50747514 ↗
• InjurySep 13, 2026Malposition of Device

  Patient problems: Perforation

  MAUDE report 50747513 ↗
• InjuryJul 2, 2026No Apparent Adverse Event

  IT WAS REPORTED TO BIOPROTECT LTD. THAT A BIOPROTECT BALLOON IMPLANTATION PROCEDURE WAS PERFORMED ON (B)(6) 2026. DURING PLANNING CT ON (B)(6) 2026 IT WAS FOUND THAT THE BALLOON APPEARANCE ON CT WAS NOT AS EXPECTED. A DISCUSSION WITH THE PHYSICIAN REVEALED THAT THE BALLOON WAS INTENTIONALLY FILLED WITH CONTRAST MEDIA RATHER THAN SALINE AS SPECIFIED IN THE PRODUCT'S INSTRUCTIONS FOR USE (ALSO EMPHASIZED DURING PHYSICIAN'S TRAINING). THE PATIENT UNDERWENT AN ADDITIONAL PROCEDURE WHERE THE CONTRAST MEDIA WAS REMOVED FROM THE BALLOON AND REPLACED WITH SALINE. THE INVESTIGATION FINDINGS SUGGEST THAT THE ROOT CAUSE OF THE EVENT IS RELATED TO ABNORMAL USE RATHER THAN TO A DEVICE-RELATED ISSUE. THE PATIENT DID NOT PRESENT ANY CLINICAL SYMPTOMS, AND HIS RADIATION TREATMENT WAS DELAYED FOR APPROXIMATELY 1 MONTH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25688861 ↗
• InjuryMay 19, 2026Malposition of Device

  IT WAS REPORTED TO BIOPROTECT LTD. THAT A BIOPROTECT BALLOON IMPLANTATION PROCEDURE WAS PERFORMED ON (B)(6) 2026. ULTRASOUND VISUALIZATION WAS POOR DUE TO PATIENT'S INSUFFICIENT BOWEL PREPARATION AND THIN RECTAL WALL. DIGITAL RECTAL EXAMINATION (DRE) AND CT FOLLOWING THE PROCEDURE CONFIRMED THE BALLOON WAS PLACED IN THE LUMEN OF THE RECTUM. THE PATIENT WAS REFERRED TO A LOCAL ER WHERE THE BALLOON WAS SUBSEQUENTLY ASPIRATED AND REMOVED. A 5 MM PUNCTURE IN THE RECTAL WALL WAS REPAIRED BY A COLORECTAL SURGEON. THE PATIENT IS EXPECTED TO RECEIVE A REPLACEMENT SPACER, AND HIS RADIATION TREATMENT WAS DELAYED.

  Patient problems: Perforation

  MAUDE report 25216898 ↗
• InjuryMar 30, 2026Difficult or Delayed Positioning

  IT WAS REPORTED TO BIOPROTECT LTD. ON (B)(6) 2026 THAT A BIOPROTECT BALLOON IMPLANTATION PROCEDURE WAS PERFORMED ON (B)(6) 2026. THE PROCEDURE WAS DONE UNDER LOCAL ANESTHESIA FOLLOWING PLACEMENT OF FIDUCIAL MARKERS. DURING THE PROCEDURE, MULTIPLE PLACEMENT ATTEMPTS WERE REQUIRED AFTER AN INITIAL TRACT EXTENDED BEYOND THE PROSTATIC APEX AND ENGAGED THE POSTERIOR CAPSULE. THE BALLOON WAS ULTIMATELY DEPLOYED IN AN ACCEPTABLE POSITION. POST-PROCEDURE, THE PATIENT DEVELOPED URINARY RETENTION REQUIRING FOLEY CATHETER PLACEMENT, WHICH RESOLVED WITHIN 48 HOURS. PLANNING MRI (B)(6) 2026), IMAGING RAISED CONCERN FOR HEMATOMA AND POSSIBLE VASCULAR INJURY. SUBSEQUENT DYNAMIC CONTRAST MRI SUGGESTED A PERIPROSTATIC ARTERIOVENOUS FISTULA, AND THE PATIENT UNDERWENT SUCCESSFUL COIL EMBOLIZATION WITH RESOLUTION OF THE VASCULAR ABNORMALITY. THE REMAINING PELVIC VASCULATURE WAS UNREMARKABLE. THE PATIENT WAS ADMITTED FOR 24-HOUR OBSERVATION AND WAS REPORTED TO BE FINE. HIS RADIATION TREATMENT (SBRT) HAS BEEN DELAYED, AND NEW PLANNING IMAGING WILL BE SCHEDULED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Urinary Retention

  MAUDE report 24730457 ↗
• InjuryMar 16, 2026Adverse Event Without Identified Device or Use Problem

  MFR REPORT #: 3014285231-2026-00002 IT WAS REPORTED TO BIOPROTECT LTD. ON (B)(6) 2026 THAT A BIOPROTECT BALLOON IMPLANTATION PROCEDURE WAS PERFORMED ON (B)(6) 2026. THE PROCEDURE WAS DONE UNDER MONITORED ANESTHESIA CARE (MAC)FOLLOWING PLACEMENT OF FIDUCIAL MARKERS AND COMPLETED AS EXPECTED. ON SIMULATION CT PERFORMED ON (B)(6) 2026, THE PATIENT PRESENTED WITH A DISTENDED BLADDER. A FOLEY CATHETER WAS PLACED AND THE PATIENT WAS PRESCRIBED FLOMAX. ON (B)(6) 2026, THE PHYSICIAN PARTIALLY ASPIRATED THE BALLOON, AND THE CATHETER WAS REMOVED. THE PATIENT'S SYMPTOMS WERE RELIEVED, AND HE STARTED HIS RADIATION TREATMENT AS PLANNED WITH NO DELAY.

  Patient problems: Urinary Retention

  MAUDE report 24613690 ↗
• InjuryFeb 26, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BIOPROTECT LTD. ON (B)(6) 2026 THAT A BIOPROTECT BALLOON IMPLANTATION PROCEDURE WAS PERFORMED ON (B)(6) 2026. THE PROCEDURE WAS DONE UNDER MONITORED ANESTHESIA CARE (MAC)FOLLOWING PLACEMENT OF FIDUCIAL MARKERS AND COMPLETED AS EXPECTED. ON SIMULATION CT PERFORMED ON (B)(6) 2026, THE PATIENT PRESENTED WITH A DISTENDED BLADDER. A FOLEY CATHETER WAS PLACED AND THE PATIENT WAS PRESCRIBED FLOMAX. ON (B)(6) 2026, THE PHYSICIAN PARTIALLY ASPIRATED THE BALLOON, AND THE CATHETER WAS REMOVED. THE PATIENT'S SYMPTOMS WERE RELIEVED, AND HE STARTED HIS RADIATION TREATMENT AS PLANNED WITH NO DELAY.

  Patient problems: Urinary Retention

  MAUDE report 24454146 ↗