JUVEDERM ULTRA XC 93899Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10888628000070), received between Oct 25, 2016 and Mar 11, 2019 — classified as 3 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Detachment Of Device Component” (4 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryMar 11, 2019Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  HEALTHCARE PROFESSIONAL REPORTED TO HAVE INJECTED A PATIENT IN THE CHEEKS AND TEMPLE WITH 2 SYRINGES OF JUVÉDERM ULTRA¿ XC. OVER A MONTH LATER, THE PATIENT EXPERIENCED A REACTION; THE PATIENT INITIALLY EXPERIENCED LYMPHATIC SWELLING, THEN FULL FACE AND UNDER EYES SWELLING, AND NODULES IN THE RIGHT CHEEK. THE HEALTHCARE PROFESSIONAL FURTHER REPORTED THAT ON THE DATE OF ONSET THE PATIENT HAD SOME SWELLING UNDER THE EYES AND THE PATIENT WAS TOLD TO MASSAGE. THE SWELLING CONTINUED, SO PATIENT WAS TOLD TO MASSAGE UNDER THE EYE. THE PATIENT WAS THEN GIVEN ANTIHISTAMINES, HYDROCHLOROTHIAZIDE, AND DOXY 100MG BID. ABOUT 3 WEEKS LATER, THE PATIENT WAS NOT BETTER. THERE WERE VISIBLE NODULES ON THE RIGHT CHEEK. PATIENT WAS INJECTED WITH VITRASE®. ABOUT A WEEK LATER, THE NODULES WERE STILL PRESENT, SO THE PATIENT WAS INJECTED WITH HYLENEX AND PUT ON STEROIDS. THE SWELLING GOT BETTER AND THE NODULES SMALLER. THE STEROID WAS LOWERED. THE PATIENT WAS ADDITIONALLY TREATED WITH PREDNISONE. THE SYMPTOMS RESOLVED ALMOST 3 MONTHS AFTER THE DATE OF ONSET. THIS IS THE SAME EVENT AND THE SAME PATIENT REPORTED UNDER MDR ID # 3005113652-2019-00193 (ALLERGAN COMPLAINT # (B)(4)). THIS IS THE FIRST MDR SUBMITT

  Patient problems: Edema; Skin Irritation

  MAUDE report 8409732 ↗
• InjuryDec 28, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED AFTER INJECTION IN THE "GLABELLA AND PRE JOWL FOCUS" WITH ONE SYRINGE JUVÉDERM® ULTRA XC, THE PATIENT EXPERIENCED ¿REDNESS THAT WAS FOUND TO BE A VASCULAR EVENT¿ NOTICED TWO DAYS AFTER INJECTION. 6 DAYS AFTER INJECTION, THE PATIENT WAS INJECTED WITH HYLENEX AS TREATMENT; 3 DAYS LATER, NITROBID PASTE WAS GIVEN AS TREATMENT. SYMPTOMS ARE ONGOING.

  Patient problems: Erythema; Vascular System (Circulation), Impaired

  MAUDE report 8202293 ↗
• MalfunctionNov 2, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  HEALTHCARE PROFESSIONAL CALLED TO REPORT DURING INJECTION, ONE SYRINGE OF JUVEDERM ULTRA XC HAD A NEEDLE DISENGAGEMENT. PATIENT CONTACT WAS MADE. NO INJURY OCCURRED. THE ALLERGAN PACKAGED NEEDLE WAS USED AND TIGHTENED BY HAND. THIS WAS CONFIRMED THE INITIAL USE OF THE SYRINGE. THE SYRINGE IS AVAILABLE FOR RETURN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8033613 ↗
• MalfunctionOct 26, 2017Detachment Of Device Component; Detachment Of Device Component

  COMPANY REPRESENTATIVE REPORTED DURING INJECTION OF 1 SYRINGE OF JUVÉDERM® ULTRA XC ¿THE NEEDLE POPPED OFF WHILE INJECTING." PATIENT CONTACT WAS MADE. NO INJURY TO PATIENT, STAFF, OR INJECTOR. THE PACKAGED NEEDLE WAS USED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6982011 ↗
• MalfunctionJun 16, 2017Coagulation in Device or Device Ingredient; Detachment Of Device Component; Difficult or Delayed Positioning; Coagulation in Device or Device Ingredient; Detachment Of Device Component; Difficult or Delayed Positioning

  HEALTHCARE PROFESSIONAL REPORTED WITH 1 SYRINGE OF JUVÉDERM® ULTRA XC, ¿THE NEEDLE BUSTED OFF WHILE INJECTING CAUSING THE PRODUCT TO COME OUT¿ AND ¿THE JUVÉDERM® HAD A HARDER CONSISTENCY MAKING IT DIFFICULT TO COME OUT.¿ PATIENT CONTACT WAS MADE. NO INJURY TO PATIENT, STAFF, OR INJECTOR. THE PACKAGED NEEDLE WAS USED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6648679 ↗
• MalfunctionApr 5, 2017Detachment Of Device Component; Detachment Of Device Component

  HEALTHCARE PROFESSIONAL REPORTED THAT DURING INJECTION WITH A SYRINGE OF JUVÉDERM® ULTRA XC USING THE PACKAGED NEEDLE, THE NEEDLE DISENGAGED. THERE WERE NO REPORTED INJURIES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6459755 ↗
• MalfunctionMar 28, 2017Detachment Of Device Component; Gel Leak; Detachment Of Device Component; Gel Leak

  HEALTHCARE PROFESSIONAL REPORTED DURING INJECTION WITH A SYRINGE OF JUVÉDERM® ULTRA XC THE NEEDLE DISENGAGED AND PRODUCT WAS LOST. HEALTHCARE PROFESSIONAL ADDITIONALLY REPORTED ¿BUBBLES¿ IN SYRINGE. NO INJURY TO PATIENT OR INJECTOR.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6438632 ↗
• InjuryOct 25, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED FROM HEALTHCARE PROFESSIONAL THAT SYMPTOMS HAVE RESOLVED AS OF (B)(6) 2016.

  Patient problems: Edema; Erythema; Skin Irritation

  MAUDE report 6053405 ↗