JUVEDERM ULTRA 93897Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10888628000032), received between Apr 17, 2017 and Jun 1, 2018 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Detachment Of Device Component” (3 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 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 1, 2018Detachment Of Device Component; Expulsion; Detachment Of Device Component; Expulsion

  HEALTHCARE PROFESSIONAL REPORTED 1 SYRINGE OF JUVÉDERM® ULTRA HAD ¿THE NEEDLE DISENGAGED AND THE NEEDLE WAS STUCK IN THE PATIENT¿S FACE WITH THE FILLER EVERYWHERE.¿ PATIENT CONTACT WAS MADE, BUT THERE WAS NO INJURY TO PATIENT, STAFF, OR INJECTOR. THE PACKAGED NEEDLE WAS USED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7561482 ↗
• MalfunctionMar 12, 2018Gel Leak; Detachment of Device or Device Component; Gel Leak; Detachment of Device or Device Component

  HEALTHCARE PROFESSIONAL REPORTED A SYRINGE OF JUVÉDERM® ULTRA HAD THE "NEEDLE POPPED OUT" AND THE PRODUCT "SQUIRTS ALL OVER THE PATIENT'S FACE" DURING INJECTION. NO NOTED INJURY TO PATIENT OR STAFF. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7331456 ↗
• MalfunctionMay 12, 2017Detachment Of Device Component; Expulsion; Detachment Of Device Component; Expulsion

  HEALTHCARE PROFESSIONAL REPORTED THAT DURING INJECTION WITH ONE SYRINGE OF JUVÉDERM® ULTRA, THE NEEDLE BROKE OFF AND THE PRODUCT CAME OUT. THE PACKAGED NEEDLE WAS USED. PATIENT CONTACT WAS MADE BUT THERE WERE NO REPORTED INJURIES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6563932 ↗
• MalfunctionApr 17, 2017Detachment Of Device Component; Detachment Of Device Component

  HEALTHCARE PROFESSIONAL REPORTED THAT DURING INJECTION WITH ONE SYRINGE OF JUVÉDERM® ULTRA, THE ¿NEEDLE CAME OFF.¿ NO REPORTED INJURIES. THE PACKAGED NEEDLE WAS USED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6497385 ↗