Solesta Gel 1.0 mL SyringeRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00850004725016), received between Jun 14, 2022 and Apr 17, 2025 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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

• MalfunctionApr 17, 2025Break; Break

  ON MARCH 24, 2025, PALETTE LIFE SCIENCES RECEIVED A NOTIFICATION IN WHICH IT WAS REPORTED THAT "THE PHYSICIAN PERFORMED A PROCEDURE ON (B)(6) 2025 AND STATED THE TIP OF THE SYRINGE BROKE IN HALF DURING THE INJECTION PROCEDURE. NO ADVERSE EVENT OR INJURY WAS REPORTED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT SYRINGE FROM A NEW KIT. THE SYRINGE IS AVAILABLE FOR RETRIEVAL.".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21860141 ↗
• MalfunctionJul 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON 05-JUL-2024, PALETTE LIFE SCIENCES RECEIVED A NOTIFICATION FROM [PATIENT'S FAMILY MEMBER] "THE [PATIENT] UNDERWENT A SOLESTA PROCEDURE ON (B)(6) 2024 FOR THE TREATMENT OF FECAL INCONTINENCE. THE [PATIENT] RECEIVED FOUR INJECTIONS IN THE RECTUM, AND THIS WAS THE FIRST TIME THE [PATIENT] HAD EVER RECEIVED SOLESTA. THE [PATIENT] HAS BEEN EXPERIENCING FECAL INCONTINENCE FOR APPROXIMATELY ONE YEAR. [PATIENT'S FAMILY MEMBER] MENTIONED THAT WHEN THE [PATIENT] GETS UP IN THE MORNING, FECES "COMES OUT" AND "GOES ON THE FLOOR." THE FECES WAS DESCRIBED AS "A BIT SOFT," BUT NOT WATERY LIKE DIARRHEA. DESPITE THE SOLESTA PROCEDURE, THE [PATIENT'S] FECAL INCONTINENCE CONTINUES. THE [PATIENT'S FAMILY MEMBER] STATED THAT THE EVENT STARTED ON (B)(6) 2024, AFTER THE SOLESTA PROCEDURE, BUT WITH GREATER FREQUENCY SINCE THE PROCEDURE. THE FECAL INCONTINENCE TYPICALLY OCCURS WHEN THE [PATIENT] GETS UP IN THE MORNING AND HAS OCCURRED FOUR TIMES AT THE TIME OF THIS REPORT, ONCE DAILY SINCE THE [PATIENT] RECEIVED SOLESTA, EXCEPT ON (B)(6) 2024." THE [PATIENT'S FAMILY MEMBER] REPORTED THAT THE [PATIENT] IS FOLLOWING A HIGH-FIBER DIET AND TAKING FIBER POWDER POST-PROCEDURE. THE REPORTER WAS ADVISED TO CONT

  Patient problems: Fecal Incontinence

  MAUDE report 19726744 ↗
• MalfunctionJul 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON 01-JUL-2024, PALETTE LIFE SCIENCES RECEIVED A NOTIFICATION FROM THE [PHYSICIAN] "[PATIENT] 5 DAYS POST SOLESTA INJECTION EXPERIENCED 2 DAYS OF LOW-GRADE FEVER AND A FEELING OF FULLNESS, CONSTIPATION, AND INCOMPLETE BOWEL EMPTYING.". THE PHYSICIAN REPORTED THE PATIENT HAS BEEN TAKING MAGNESIUM AND COLACE FOR CONSTIPATION POST-PROCEDURE. MULTIPLE ATTEMPTS FOR ADDITIONAL INFORMATION HAVE BEEN REQUESTED FROM THE COMPLAINANT HAS BEEN UNSUCCESSFUL AT THE TIME OF THIS REPORT. THE PATIENT'S CONDITION IS UNKNOWN.

  Patient problems: Constipation; Fever

  MAUDE report 19706707 ↗
• MalfunctionJun 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2024 PALETTE LIFE SCIENCES RECEIVED THE FOLLOWING REPORT FROM THE [PATIENT] "[PATIENT] RECEIVED A SOLESTA TREATMENT FROM HER [PHYSICIAN] DUE TO FECAL INCONTINENCE ON (B)(6) 2024. AFTER THE PROCEDURE, THE [PATIENT] BEGAN TO EXPERIENCE CONSTIPATION. [PATIENT] WAS HOSPITALIZED ON (B)(6) 2024 WITH A BOWEL IMPACTION THAT REQUIRED INTERVENTION TO REMOVE MANUALLY. THE [PATIENT] WAS IN THE HOSPITAL FOR ABOUT 6 HOURS BEFORE BEING DISCHARGED. THE [PATIENT] REPORTED THAT HAS STILL NOT HAD A NORMAL BOWEL MOVEMENT AND REPORTED THAT THEY ARE SMALLER THAN NORMAL." PATIENT REPORTED TAKING DULCOLAX, LINZESS, MIRALAX FOR CONSTIPATION POST PROCEDURE. MULTIPLE ATTEMPTS FOR ADDITIONAL INFORMATION HAVE BEEN REQUESTED FROM THE COMPLAINANT HAS BEEN UNSUCCESSFUL AT THE TIME OF THIS REPORT. PATIENT'S CONDITION IS UNKNOWN.

  Patient problems: Constipation

  MAUDE report 19589425 ↗
• MalfunctionJun 14, 2024Migration; Migration

  ON 14-MAR-2024, PALETTE LIFE RECEIVED NOTIFICATION OF THE FOLLOWING COMPLAINT: "ON (B)(6) .2024, [PALETTE SALES REPRESENTATIVE] RECEIVED A PHONE CALL ON HER MOBILE PHONE FROM THE PATIENT. THIS PATIENT WAS INJECTED WITH SOLESTA ON (B)(6) 2023, BY THE PHYSICIAN. THE PATIENT COMPLAINS THAT SINCE THE INJECTION HE HAS HAD A FEELING OF BOWEL FULLNESS AND CONSTIPATION, NAUSEA, AND NO APPETITE, HE HAS HAD A CT SCAN THAT SHOWED A MASS IN HIS RECTUM. HE ALSO COMPLAINED OF URINARY URGENCY AND FREQUENCY. AN MRI IS SCHEDULED FOR NEXT WEEK. THE PATIENT WAS ADVISED TO FOLLOW UP WITH HIS PHYSICIAN. [PALETTE SALES REPRESENTATIVE] ALSO REACHED OUT TO [PHYSICIAN] VIA EMAIL TO LET HIM KNOW THAT THIS PATIENT HAD CALLED WITH A COMPLAINT AND TO SUPPLY INFORMATION ON [PATIENT HISTORY, CURRENT STATUS HISTOLOGY, AND RADIOGRAPHIC IMAGING]." ON 15-MAR-2024 ADDITIONAL INFORMATION WAS RECEIVED FROM [PALETTE SALES REPRESENTATIVE] THAT STATED THE FOLLOWING: IT WAS CLARIFIED TO THE [PHYSICIAN] THAT THE PATIENT REPORTED THE INCIDENT DIRECTLY TO THE MANUFACTURER. IN ADDITION, THE PATIENT PREVIOUSLY REPORTED AN ADVERSE EVENT WITH HIS SOLESTA INJECTION ON (B)(6) 2023 THAT WAS FILED [INTERNALLY WITHIN PALETTE LIFE COMP

  Patient problems: Constipation; Nausea; Urinary Frequency / Polyuria

  MAUDE report 19538941 ↗
• InjuryJun 14, 2022Adverse Event Without Identified Device or Use Problem

  INTERNATIONAL JOURNAL OF GYNECOLOGICAL PATHLOGY - 001:1-4 DESCRIBES INCIDENT OF FEMALE PATIENT DIAGNOSED WITH 'VAGINAL CYST'.

  Patient problems: Cyst(s)

  MAUDE report 14688194 ↗