Radiesse Injectable Implant1.5cc 8071M0H1Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI M2138071M0H15), received between Aug 28, 2025 and Aug 28, 2025 — classified as 1 injury.

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

2 other recalls cover devices cleared under the same FDA submission (P050037); they may or may not involve this specific model.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryAug 28, 2025Off-Label Use; Adverse Event Without Identified Device or Use Problem; Migration; Off-Label Use; Adverse Event Without Identified Device or Use Problem; Migration

  CASE DESCRIPTION: THIS SPONTANEOUS REPORT WAS RECEIVED FROM A US PHYSICIAN AND CONCERNS A 68-YEAR-OLD MALE PATIENT. THE PATIENT WAS INJECTED BILATERALLY WITH RADIESSE FROM THE LATERAL AREAS TO THE ORAL COMMISSURES (OFF LABEL USE OF DEVICE), ON 30-APR-2025. BATCH NUMBER WAS REPORTED AS A00125150 (EXPIRY DATE: 30-APR-2026). THE BATCH RECORD REVIEW WAS RECEIVED AND THE LOT NUMBER FOR RADIESSE WAS CONFIRMED AS A00125150 (EXPIRY DATE: 30-APR-2026). A LOT SEARCH IN THE GLOBAL SAFETY DATABASE WAS CONDUCTED. FOUR SYRINGES OF RADIESSE WERE INJECTED USING A NEEDLE. RADIESSE WAS NOT DILUTED. THE PATIENT WAS PREVIOUSLY INJECTED WITH BOTOX® AND RADIESSE, WHICH WAS WELL TOLERATED AND WITHOUT ANY ADVERSE REACTIONS. HE HAD NO PAST AESTHETIC INJECTIONS IN THE AREA INJECTED WITH RADIESSE. THE PATIENT WAS ALLERGIC TO ASPIRIN AND PENICILLIN. HIS RELEVANT MEDICAL HISTORY INCLUDED HUMAN IMMUNODEFICIENCY VIRUS (REPORTED AS HIV +). HIS CONCOMITANT MEDICATIONS INCLUDED BIKTARVY, SEROSTIM, LOSARTAN WITH AMLODIPINE, TESTOSTERONE, ALLOPURINOL, CRESTOR, VESICARE, AND MYRBETRIQ. ON (B)(6) 2025, AFTER THE RADIESSE INJECTION, THE PATIENT EXPERIENCED THAT THE AREA FELT ENCAPSULATED, HARD, LIKE A LUMP LATERAL TO TH

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Deposits; No Clinical Signs, Symptoms or Conditions; Subcutaneous Nodule; Swelling/ Edema

  MAUDE report 22916362 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P050037. One submission often covers many models, so check the product and lot details in each record.

• Z-0145-2012 · Aug 18, 2011 · Terminated
  MERZ AESTHETICS, Radiesse Volume Advantage 1.5 CC, Injectable Implant, Part Number 8071M0H1 and 8071M0K1, Sterile, Rx ONLY. Part Number 8071M4K1 distributed in Canada Part Number
• Z-2221-2011 · Apr 6, 2011 · Terminated
  Radiesse, Injectable Implant - 1.3cc Syringe, Sterile, Sterilized Using Steam, Use Before 2013-01, Ref 8046M7, Lot 1024417, Manufactured by: BioForm Medical Inc, 4133 Courtney Rd #