SpaceOAR VUE™ System - 10mL SV-2101Recalls & reported problems

Summary

The FDA's MAUDE database contains 414 adverse event reports that list this exact device (DI 00864661000140), received between Oct 20, 2022 and Sep 30, 2026 — classified as 4 deaths, 104 injuries, 306 malfunctions.

The most frequently reported specific device problem is “Positioning Problem” (215 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Feb 24, 2022Class IIOpen, Classified

   Users need to be aware that embolism is a possible adverse event associated with hydrogel misplacements. Updated IFU provides new procedural instructions, warnings and precautions that describe steps to verify correct placement of the hydrogel following implantation, as well as technique recommendations for the proper placement of SpaceOAR and SpaceOAR Vue.

   Z-1003-2022 · Root cause: Labeling design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 414 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Obstruction of Flow

  It was reported that a SpaceOAR Vue placement procedure was performed on (b)(6)2026. During the hydrodissection, the first attempt was not successful, an explanation of the correct method, the physician repositioned the needle several times in an attempted to achieve safe hydrodissection, upon the last attempt the physician felt comfortable moving forward the hydrogel injection. After 2 cc the physician felt resistance and could not push more hydrogel out of the system, the kit was removed ant was handed off to the nurse who confirmed that the kit clogged. The decision was to discontinue the procedure. The patient was under monitoring anesthesia care (MAC) and was reported stable.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50946854 ↗
• MalfunctionSep 25, 2026Malposition of Device

  It was reported that after a SpaceOAR placement procedure, the radiation oncologist discovered a misplacement of the hydrogel, the physician was evaluating the radiation treatment options as the patient was planned for external beam radiation therapy. No patient complications have been reported as result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50899437 ↗
• MalfunctionSep 24, 2026Malposition of Device

  Patient problems: Dysuria

  MAUDE report 50885289 ↗
• MalfunctionSep 16, 2026Malposition of Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50789771 ↗
• InjurySep 11, 2026Adverse Event Without Identified Device or Use Problem

  It was reported after the SpaceOAR Vue placement procedure, around two months after the hydrogel was placed, the hydrogel looked normal under ultrasound at the time of injection. The post implant magnetic resonance imaging (MRI) and computed tomography (CT) confirmed the hydrogel placement looked normal. Halfway through moderate hypofractionation radiotherapy, a computed beam computed tomography (CBCT) performed prior to a radiation treatment showed air bubbles in the perirectal fat. This was assessed by the physician as a possible infection, the patient was prescribed antibiotics and steroids, an MRI was scheduled, the physician mentioned that this might be a walled off collection of the spacer. The patient is currently stable and clinically improving without many symptoms.

  Patient problems: Unspecified Infection

  MAUDE report 50726550 ↗
• MalfunctionSep 11, 2026Malposition of Device

  It was reported that during follow up SpaceOAR Vue placement procedure, the physician reported that the imaging showed a clearly capsule injection of the hydrogel, it was estimated that the 10cc were misplaced into the wrong location. There were no patient complications, however the physician decided to delay the radiation treatment of the patient.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50726276 ↗
• MalfunctionSep 9, 2026Use of Device Problem; Malposition of Device

  It was reported to Boston Scientific Corporation that a SpaceOAR Vue was used during a placement procedure on (b)(6)2026, under local anesthesia.During hydrodisection, saline was observed in the rectum. Needle repositioning was instructed; however, the instructions were not followed, and the hydrogel was suspected to be injected in the rectum. There were no patient complications reported, the radiation therapy moved forward.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50693708 ↗
• MalfunctionSep 9, 2026Malposition of Device

  It was reported to Boston Scientific Corporation that a SpaceOAR Vue was used during a placement procedure on (b)(6) 2026.During the patient's treatment planning, a Magnetic Resonance Imaging (MRI) found an anterior rectal wall infiltration. The physician reported a conservative management. The patient had not yet started his radiation treatment.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50684123 ↗
• MalfunctionSep 8, 2026Material Integrity Problem

  It was reported that during the follow up SpaceOAR placement procedure, it was noted that hydrogel still present in the perirectal space after 12 months. The patient did not report any adverse events.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50670293 ↗
• MalfunctionSep 4, 2026Malposition of Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50617599 ↗
• InjurySep 2, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Abscess; Discomfort; Fever; Pain; Unspecified Infection

  MAUDE report 50569005 ↗
• MalfunctionAug 31, 2026Malposition of Device

  It was reported that during post imaging of the SpaceOAR Vue placement procedure, the physician reported a mild rectal wall infiltration of the hydrogel, most of it was in the correct place. The patient experienced mild constipation for two days after the hydrogel placement. However, this has subsided. The patient will received radiation treatment as planned, no complications were reported as resulted of this event.

  Patient problems: Constipation

  MAUDE report 50515540 ↗
• InjuryAug 31, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that during a follow up after the SpaceOAR Vue placement procedure, the patient received hydrogel 6 months ago and proceed with radiation therapy with no issues, then the patient started experiencing severe pain the rectal area with bowel movements that got worse at the point that was unable to go to work. The patient was sent to a colorectal surgeon who scoped him and found a mass on the left side of the rectum that was biopsied and called as nonmalignant, additionally the computed tomography (CT) showed a slight inflammation in the rectal area.The patient was treated with rectal hydrocortisone, preparation H, proctofoam and a Carafate suppository. Additionally, pain has been treated with narcotics as nothing else was helpful. The relationship between the device and the event has been reported as unknown.It was also reported that the patient was scheduled for a magnetic resonance imaging (MRI).

  Patient problems: Diarrhea; Discomfort; Inflammation; Pain

  MAUDE report 50515529 ↗
• MalfunctionAug 28, 2026Use of Device Problem; Malposition of Device; Material Integrity Problem

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 50489091 ↗
• MalfunctionAug 25, 2026Malposition of Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50422512 ↗
• InjuryAug 21, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the following days after SpaceOAR Vue placement procedure, the patient presented in the emergency room with severe pain and discomfort in the rectum, therefore, the computed tomography (CT) of the placement were reviewed, this showed that were in the correct place. The patient was hospitalized where was treated and test were performed. The patient was later discharged from hospital, doing well.The relationship between the device and the procedure were reported as unknown.

  Patient problems: Discomfort; Pain

  MAUDE report 50374604 ↗
• MalfunctionAug 21, 2026Malposition of Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50374594 ↗
• MalfunctionAug 21, 2026Malposition of Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50374577 ↗
• MalfunctionAug 21, 2026Malposition of Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50372500 ↗
• DeathAug 20, 2026Adverse Event Without Identified Device or Use Problem

  It was reported to Boston Scientific Corporation that a SpaceOAR Vue device was used during a placement procedure on (b)(6) 2026. The procedure was completed successfully without any reported device performance issues. Following completion of the procedure, the patient reportedly developed dizziness and an unspecified reaction while being removed from the stirrups. The patient was transferred to the Intensive Care Unit (ICU) for further medical management and subsequently expired.At the time of this report, the nature of the reported reaction has not been further described. The patient's date and cause of death have not been provided. No additional clinical information, including diagnostic findings, physician assessment, autopsy results, contributing medical conditions, or details regarding any potential relationship between the reported event, the procedure, the device, or the patient's death, has been received. Therefore, the relationship, if any, between the device and the patient's death remains unknown. If more information becomes available a supplemental report will be submitted.Additional Information:After the procedure, prior to discharge, the patient felt itchy, nauseated

  Patient problems: Cardiac Arrest; Diaphoresis; Diminished Pulse Pressure; Dizziness; Dyspnea; Hemorrhage/Blood Loss/Bleeding; Itching Sensation; Nausea; Shock; Speech Disorder

  MAUDE report 50335458 ↗
• MalfunctionAug 14, 2026Malposition of Device

  Patient problems: Micturition Urgency; Urinary Frequency / Polyuria

  MAUDE report 50245603 ↗
• MalfunctionAug 11, 2026Malposition of Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50204407 ↗
• MalfunctionAug 11, 2026Malposition of Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50204403 ↗
• MalfunctionAug 11, 2026Malposition of Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50204402 ↗
• MalfunctionAug 11, 2026Malposition of Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50204397 ↗