Barrigel 011508Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00850004725108), received between Sep 28, 2023 and Sep 24, 2024 — classified as 2 deaths, 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Malposition of Device” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjurySep 24, 2024Malposition of Device; Malposition of Device

  ON 20-AUG-2024 PALETTE LIFE SCIENCES RECEIVED A NOTIFICATION FROM A [CONSULTANT] WHO RECEIVED IT FROM A [PHYSICIAN] IN THE UNITED KINGDOM (UK). IT WAS REPORTED THAT "[CONSULTANT] WAS MADE AWARE ON 19-AUG-2024 ABOUT A COUPLE OF POTENTIAL RWIS IN A [HOSPITAL] IN (B)(6), UK. [PHYSICIANS] REPORTED THAT BOTH PATIENTS ARE GOOD AND ASYMPTOMATIC. BOTH PATIENTS WILL BE REVIEWED ON (B)(6) 2024. ISSUES WITH THE INJECTION PROCESS, AND VISIBILITY LOST DURING DEPLOYMENT AS THE PATIENT WAS TENSE. THE PROCESS STALLED UNTIL THE PATIENT RELAXED, THEN DEPLOYMENT CONTINUED. BECAUSE OF VISIBILITY, THE NEEDLE WAS WITHDRAWN, AND ACCESS AGAIN TOOK PLACE. [PHYSICIAN] THOUGHT WAS IN THE CORRECT LOCATION AND 9ML WAS DEPLOYED. APPROX 1 CENTIMETER AROUND MID-PROSTATE STALLED AND DID NOT GO BEYOND. ON TRUS NO SUGGESTION OF RWI AND THE PATIENT WAS REPORTED AS FINE". ADDITIONAL INFORMATION RECEIVED ON 23-AUG-2024 INDICATED THAT THE TWO POTENTIAL CASES OCCURRED IN A [HOSPITAL] IN (B)(6) ON (B)(6) 2024. BARRIGEL LOT NUMBER INVOLVED: 21200-1, EXPIRY DATE OF NOV-2025. FURTHER ADDITIONAL INFORMATION RECEIVED ON 02-SEP-2024 FROM THE [PHYSICIAN] INDICATED THAT ENDOSCOPY "HAS NOT SHOWN ANY RECTAL MUCOSAL DAMAGE. ALL CLEA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20293190 ↗
• InjurySep 24, 2024Malposition of Device; Malposition of Device

  ON 20-AUG-2024 PALETTE LIFE SCIENCES RECEIVED A NOTIFICATION FROM A [CONSULTANT] WHO RECEIVED IT FROM A [PHYSICIAN] IN THE UNITED KINGDOM (UK). IT WAS REPORTED THAT "[CONSULTANT] WAS MADE AWARE ON 19-AUG-2024 ABOUT A COUPLE OF POTENTIAL RWIS IN A [HOSPITAL] IN STOKE, UK. [PHYSICIANS] REPORTED THAT BOTH PATIENTS ARE GOOD AND ASYMPTOMATIC. BOTH PATIENTS WILL BE REVIEWED ON (B)(6) 2024. ISSUES WITH THE INJECTION PROCESS, AND VISIBILITY LOST DURING DEPLOYMENT AS THE PATIENT WAS TENSE. THE PROCESS STALLED UNTIL THE PATIENT RELAXED, THEN DEPLOYMENT CONTINUED. BECAUSE OF VISIBILITY, THE NEEDLE WAS WITHDRAWN, AND ACCESS AGAIN TOOK PLACE. [PHYSICIAN] THOUGHT WAS IN THE CORRECT LOCATION AND 9ML WAS DEPLOYED. APPROX 1 CENTIMETER AROUND MID-PROSTATE STALLED AND DID NOT GO BEYOND. ON TRUS NO SUGGESTION OF RWI AND THE PATIENT WAS REPORTED AS FINE". ADDITIONAL INFORMATION RECEIVED ON 23-AUG-2024 INDICATED THAT THE TWO POTENTIAL CASES OCCURRED IN A [HOSPITAL] IN STOKE ON (B)(6) 2024. BARRIGEL LOT NUMBER INVOLVED: 21200-1, EXPIRY DATE OF NOV-2025. ADDITIONAL INFORMATION RECEIVED ON 06-SEP-2024 FROM THE [CONSULTANT] INDICATED THAT "BOTH PATIENTS HAVE NOT STARTED THEIR RADIATION TREATMENT".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20293125 ↗
• MalfunctionJul 3, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 28-JUN-2024 PALETTE LIFE SCIENCES RECEIVED THE FOLLOWING REPORT FROM A [PHYSCIAN] IN THE US "I HAVE A [PATIENT] WHO IS SCHEDULED TO BE TREATED WITH STEREOTACTIC BODY RADIOTHERAPY [SBRT] FOR FAVORABLE INTERMEDIATE RISK PROSTATE CANCER. BARRIGEL AND FIDUCIALS WERE PLACED.MAGNETIC RESONANCE IMAGING [MRI] TAKEN TO FUSE TO COMPUTED TOMOGRAPHY [CT] SIMULATION IMAGES REVEALED SIGNIFICANT INFILTRATION OF BARRIGEL INTO THE PROSTATE. THE PATIENT IS ASYMPTOMATIC." MULTIPLE ATTEMPTS FOR ADDITIONAL INFORMATION HAVE BEEN REQUESTED FROM THE COMPLAINANT HAS BEEN UNSUCCESSFUL AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19667319 ↗
• InjuryJun 13, 2024Migration; Migration

  ON FEBRUARY 12, 2024, PALETTE LIFE RECEIVED NOTIFICATION OF THE FOLLOWING COMPLAINT: "YESTERDAY, I BECAME AWARE THAT THE [PHYSICIAN] IN WEST VIRGINIA INSERTED A BARRIGEL LAST WEEK, RESULTING IN A RECTAL WALL INJECTION (RWI)." SUBSEQUENTLY, ON (B)(6) 2024, ADDITIONAL INFORMATION WAS PROVIDED, INDICATING DIFFICULTIES WITH THE DEVICE, PARTICULARLY IN CASES OF INCORRECT PLACEMENT. IT WAS NOTED THAT A BARRIGEL MISALIGNMENT HAD OCCURRED, NECESSITATING THE INSERTION OF A NEW BARRIGEL TO REPLACE THE OLD ONE, WHICH WAS REMOVED USING A DISSOLVING SOLUTION. FOLLOWING THE PLACEMENT OF THE NEW BARRIGEL, UROLOGISTS INVOLVED IN THE CASE DISCOVERED THE MISALIGNMENT DURING ULTRASOUND SCANNING. ON FEBRUARY 21, 2024, FOLLOW-UP INFORMATION REGARDING THE PATIENT WAS RECEIVED, REVEALING THAT THE PATIENT HAD BARRIGEL REMAINING IN THE RECTUM AND WAS SCHEDULED FOR A HYALURONIDASE INJECTION ON (B)(6), 2024, TO DISSOLVE THE BARRIGEL, FOLLOWED BY RE-IMPLANTATION ON (B)(6) 2024. ON APRIL 15, 2024, IT WAS REPORTED THAT THE REVERSAL AND REIMPLANTATION PROCEDURES WERE PERFORMED ON (B)(6) 2024. DESPITE MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE PATIENT'S STATUS AFTER THE REVERSAL AND RE-IMPLA

  Patient problems: Insufficient Information

  MAUDE report 19532606 ↗
• DeathOct 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  3 DAYS FOLLOWING TURP OF PROSTATE, FIDUCIAL MARKET PLACEMENT AND INJECTION OF BARRIGEL PATIENT PASSED AWAY AT HOME.

  Patient problems: Insufficient Information

  MAUDE report 17873497 ↗
• DeathSep 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  3 DAYS FOLLOWING TURP OF PROSTATE, FIDUCIAL MARKER PLACEMENT AND BARRIGEL INSERTION, PATIENT PASSED AWAY AT HOME. DETERMINATION OF CAUSE OF DEATH IN-PROCESS.

  Patient problems: Insufficient Information

  MAUDE report 17831191 ↗