RHA® 4 RHA® 4 US 1.2ml Schott/2 aig. TSK 27G1/2 (REF 940083/01)Recalls & reported problems
Teoxane SA · "One box of RHA® 4 contains two blisters and one instruction for use. Each blister contains a 1,2mL prefilled syringe and two needles (27G 1/2). Box Packaging (ID 07640173233800) is defined as unit of sales and identified with a serial number." · Class 3 · Implant
All models of RHA 4 (4)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07640173233756), received between Apr 2, 2024 and Apr 2, 2024 — classified as 1 injury.
The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (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.
Reports received per month
Most reported problems
Device problems
- Improper or Incorrect Procedure or Method1
- Off-Label Use1
Patient problems
- Foreign Body Embolism1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 2, 2024Off-Label Use; Improper or Incorrect Procedure or Method; Off-Label Use; Improper or Incorrect Procedure or Method
PRIMEVIGILANCE NOTIFIED TEOXANE OF AN ADVERSE EVENT ON 04-MAR-2024. A PATIENT WAS INJECTED ON (B)(6) 2024 WITH 0.5 ML OF RHA 4 IN THE TEMPLE. THE INJECTION WAS DONE SUPERFICIALLY AND ABOVE THE FASCIAL TISSUE PLANE WITH THE 25G CANNULA. TWO MINUTES AFTER THE INJECTION, ON (B)(6) 2024, THE PATIENT PRESENTED BLANCHING POSTERIOR TO THE INJECTION POINT, WHICH SPREAD TO THE RIGHT CHEEK. CAPILLARY REFILL WAS CHECKED, AND THE INJECTOR DIAGNOSED VASCULAR OCCLUSION. DUE TO THE DIAGNOSIS, WITHIN FIVE MINUTES, 16 VIALS HYALURONIDASE (HYLANEX) WAS INJECTED AND CAPILLARI REFILL RETURNED. IN ADDITION, THE INJECTOR PUT WARM COMPRESSES, MASSAGED THE AREA AND PRESCRIBED A NON STEROIDIAL ANTI-INFLAMMATORY DRUG (ACETYLSALICYLIC ACID , 325 MG), THE FOLLOWING DAY, ON (B)(6) 2024, THE SYMPTOMS SEEMED TO GET WORSE, SO THE PATIENT WAS TREATED BY ANOTHER HEALTH CARE PROFESSIONAL WHO USED A ULTRASOUND TO GUIDE HYALURONIDASE TREATMENT. DURING THE PROCEDURE, PATENT BLOOD FLOW WAS OBSERVED. IT WAS THEN PLANNED TO TREAT THE PATIENT WITH HYPERBARIC OXYGEN TO THE AFFECTED AREA (EO2 TREATMENT). AT THE TIME WE RECEIVED THE INITIAL INFORMATION, THE SYMPTOMS WERE RESOLVING. THE HISTORY OF THE PATIENT ALSO MENTIONED
Patient problems: Foreign Body Embolism
MAUDE report 19017652 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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