JUVEDERM ULTRA PLUS XC 93900Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10888628000100), received between Oct 30, 2017 and Oct 24, 2018 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Detachment Of Device Component” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 24, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  HEALTHCARE PROFESSIONAL REPORTED 1 SYRINGE OF JUVÉDERM® ULTRA PLUS XC HAD ¿THE NEEDLE POP OFF AS IT WAS BEING PULLED OUT OF THE PATIENT¿S FACE.¿ PATIENT CONTACT WAS MADE, BUT NO INJURY TO PATIENT, STAFF, OR INJECTOR. INJECTOR USED A 30G ALLERGAN NEEDLE INSTEAD OF THE 27G ONE THAT CAME WITH THE SYRINGE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8003176 ↗
• MalfunctionMay 24, 2018Detachment Of Device Component; Difficult or Delayed Positioning; Expulsion; Detachment Of Device Component; Difficult or Delayed Positioning; Expulsion

  HEALTHCARE PROFESSIONAL REPORTED ONE SYRINGE OF JUVÉDERM® ULTRA PLUS XC HAD AN ISSUE WITH PRODUCT NOT PASSING THROUGH SYRINGE DURING INJECTION. THE PHYSICIAN CHANGED THE NEEDLE TO ANOTHER ALLERGAN NEEDLE FROM THE SAME BOX. PRODUCT STILL WOULD NOT PASS, THEN POPPED THE NEEDLE OFF AND SPILLED OVER TRAY. NO PATIENT CONTACT WAS MADE. NO INJURIES WERE REPORTED. BOTH PACKAGED NEEDLES WERE USED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7541146 ↗
• MalfunctionFeb 16, 2018Detachment Of Device Component; Leak/Splash; Detachment Of Device Component; Leak/Splash

  HEALTHCARE PROFESSIONAL REPORTED DURING INJECTION WITH JUVÉDERM® ULTRA PLUS XC THE PRODUCT "STARTED COMING OUT WHERE THE NEEDLE ATTACHES TO THE SYRINGE." PATIENT CONTACT WAS MADE, BUT NO INJURY TO PATIENT, STAFF, OR INJECTOR. THE PACKAGED NEEDLE WAS USED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7278680 ↗
• MalfunctionDec 28, 2017Crack; Use of Device Problem; Detachment of Device or Device Component; Crack; Use of Device Problem; Detachment of Device or Device Component

  HEALTHCARE PROFESSIONAL REPORTED THE EVENT OF DURING PATIENT INJECTION WITH ONE SYRINGE OF JUVÉDERM® ULTRA PLUS XC THE NEEDLE DISENGAGED, THE LUER LOCK CRACKED, AND PRODUCT SPILLED OUT AT THE LUER LOCK. PATIENT CONTACT WAS MADE. NO INJURY TO THE PATIENT OR INJECTOR WAS REPORTED. THE NEEDLE FROM THE PACKAGE WAS USED. THIS WAS THE INITIAL USE OF THE SYRINGE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7151106 ↗
• MalfunctionOct 30, 2017Burst Container or Vessel; Leak/Splash; Burst Container or Vessel; Leak/Splash

  HEALTHCARE PROFESSIONAL REPORTED THE EVENT OF THAT DURING INJECTION, ONE SYRINGE OF JUVÉDERM® ULTRA PLUS XC "BUSTED" WHERE THE NEEDLE SCREWS ON AND THE INJECTOR "LOST ALL THE FILLER". PATIENT CONTACT WAS MADE. NO INJURY TO THE PATIENT, INJECTOR OR STAFF REPORTED. THE PACKAGED NEEDLE WAS USED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6988408 ↗