RHA® 3 RHA® 3 US 1ml Schott/2 aig. TSK 27G1/2Recalls & reported problems
Teoxane SA · "One box of RHA® 3 contains two blisters and one instruction for use. Each blister contains a 1mL prefilled syringe and two needles (27G 1/2). Box Packaging (ID 07640173234166) is defined as unit of sales and identified with a serial number." · Class 3 · Implant
All models of RHA 3 (2)
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 07640173234173), received between Feb 23, 2026 and Feb 23, 2026 — 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
Patient problems
- Foreign Body Embolism1
- Skin Discoloration1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryFeb 23, 2026Improper or Incorrect Procedure or Method
SLUGGISH CAPILLARY REFILL - VASCULAR OCCLUSION [VASCULAR SKIN DISORDER] ([SKIN DISCOLOURATION], [LIVEDO RETICULARIS]). CASE NARRATIVE: ON 12-FEB-2026, PRIMEVIGILANCE NOTIFIED TEOXANE GENEVA OF AN ADVERSE EVENT. A PATIENT WAS INJECTED ON (B)(6) 2026 WITH 0,1ML OF RHA 3 IN THE PIRIFORM FOSSA USING THE NEEDLE PROVIDED IN THE BOX. IMMEDIATELY AFTER THE INJECTION (ON (B)(6) 2026), THE INJECTOR NOTICED A DARKENING DISCOLORATION IN THE PIRIFORM FOSSA EXTENDING TO THE NOSE. THE PATIENT RECEIVED 4 SESSIONS OF HYALURONIDASE (HYLENEX 75-250 IU). THE INITIAL DISCOLORATION WAS RESOLVING BUT RED AND WHITE LACE-LIKE PATTERN COULD BE SEEN IN THE UPPER LIP. SOME SLUGGISH CAPILLARY REFILL PERSISTED BUT WAS < 3 SECONDS TO RETURN TO BASELINE. CONSIDERING THE SERIOUSNESS OF THE EVENT, THE CASE WAS ASSESSED AS REPORTABLE. ON 17-FEB-2026, WE RECEIVED THE CONFIRMATION THAT THE SYMPTOMS WERE LINKED TO A VASCULAR OCCLUSION AND THAT THEY WERE RESOLVED. CONSIDERING RESOLUTION OF THE SYMPTOMS, THE CASE WAS CONSIDERED CLOSED. IMDRF CODE ANNEX G IS ERRONEOUS IS THIS CASE (DUE TO DATABASE ISSUE). PLEASE CONSIDER CODE G04127 ¿ SYRINGE.
Patient problems: Foreign Body Embolism; Skin Discoloration
MAUDE report 24412892 ↗
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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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