EVOLYSSE SMOOTHRecalls & reported problems across all models
Symatese · 2 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 49
- Deaths reported
- 0
- Injuries reported
- 49
- Recalls
- 0
We found 2 models of EVOLYSSE SMOOTH by Symatese in the FDA's device registry (GUDID). Together they are named in 49 adverse event reports in the FDA's MAUDE database, received between Aug 19, 2025 and May 7, 2026 — classified as 49 injuries.
The most frequently reported specific device problem is “Off-Label Use” (32 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported EVOLYSSE SMOOTH problems
Device problems
- Off-Label Use32
- Adverse Event Without Identified Device or Use Problem16
- No Apparent Adverse Event9
- Improper or Incorrect Procedure or Method3
- Defective Device1
- Patient-Device Incompatibility1
- Use of Device Problem1
Patient problems
- Local Reaction16
- Obstruction/Occlusion10
- Swelling/ Edema8
- Nodule7
- Pain7
- Inflammation5
- Skin Discoloration5
- Hypersensitivity/Allergic reaction4
EVOLYSSE SMOOTH models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- EVOLYSSE SMOOTH EVOF1S001Implant, Dermal, For Aesthetic Use45 reports
- EVOLYSSE SMOOTH EVOF1S001-SImplant, Dermal, For Aesthetic Use4 reports
Recent EVOLYSSE SMOOTH adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryMay 7, 2026Off-Label Use; Adverse Event Without Identified Device or Use Problem
ON (B)(6) 2026, A HEALTHCARE PROVIDER REPORTED INJECTING 0.6CC OF EVOLYSSE SMOOTH INTO A FEMALE PATIENT IN THE LIPS USING A SUPERFICIAL, LINEAR THREADING TECHNIQUE WITH A 30 GAUGE NEEDLE. THE PATIENT EXPERIENCED SLIGHT BLANCHING IN THE UPPER RIGHT LIP TISSUE ALONG WITH A HEMATOMA. TREATMENT WITH ICE AND ARNICA WERE ADMINISTERED PRIOR TO THE PATIENT LEAVING THE OFFICE. THE SAME DAY AS THE INJECTION AT APPROXIMATELY 8:30 PM THE PATIENT NOTIFIED THE INJECTING PHYSICIAN AND REPORTED PAIN AND DISCOLORATION IN THE UPPER LIP AND PERIORAL AREA. THE PATIENT RETURNED TO THE OFFICE IMMEDIATELY AND A VASCULAR OCCLUSION WAS CONFIRMED BY THE HCP. SYMPTOMS INCLUDED DELAYED CAPILLARY REFILL, PAIN AND TISSUE BLANCHING. HEAT AND MASSAGE TO THE AFFECTED AREA WAS PERFORMED AND THE PATIENT WAS INJECTED WITH 2 VIALS OF HYLENEX. FOLLOWING TREATMENT, THE HCP OBSERVED THE SKIN COLOR AND CAPILLARY REFILL RETURNED TO NORMAL. THE PATIENT RETURNED HOME. ON (B)(6) 2026, THE PATIENT REPORTED HER SYMPTOMS HAD RETURNED AND A BLISTER HAD FORMED ON THE UPPER LIP. THE PATIENT WAS SENT FOR AN ULTRASOUND. THE HCP STATED THE ULTRASOUND SHOWED THE VASCULAR OCCLUSION WAS NOT FULLY RESOLVED. THE HCP INJECTED THE UPPER LIP
Patient problems: Hematoma; Obstruction/Occlusion; Pain; Pallor; Skin Discoloration
MAUDE report 25112166 ↗InjuryApr 23, 2026Off-Label Use; Adverse Event Without Identified Device or Use Problem
ON (B)(6) 2026 A HEALTHCARE PROVIDER REPORTED INJECTING 0.6 CC OF EVOLYSSE SMOOTH INTO A FEMALE PATIENT IN THE LIPS USING A SUPERFICIAL, LINEAR THREADING TECHNIQUE WITH A 30 GAUGE NEEDLE. THE PATIENT EXPERIENCED SLIGHT BLANCHING IN THE UPPER RIGHT LIP TISSUE ALONG WITH A HEMATOMA. TREATMENT WITH ICE AND ARNICA WERE ADMINISTERED PRIOR TO THE PATIENT LEAVING THE OFFICE. THE SAME DAY AS THE INJECTION, AT APPROXIMATELY 8:30 PM, THE PATIENT NOTIFIED THE INJECTING PHYSICIAN AND REPORTED PAIN AND DISCOLORATION IN THE UPPER LIP AND PERIORAL AREA. THE PATIENT RETURNED TO THE OFFICE IMMEDIATELY AND A VASCULAR OCCLUSION WAS CONFIRMED BY THE HCP. SYMPTOMS INCLUDED DELAYED CAPILLARY REFILL, PAIN AND TISSUE BLANCHING. HEAT AND MASSAGE TO THE AFFECTED AREA WAS PERFORMED AND THE PATIENT WAS INJECTED WITH 2 VIALS OF HYLENEX. FOLLOWING TREATMENT, THE HCP OBSERVED THE SKIN COLOR AND CAPILLARY REFILL RETURNED TO NORMAL. THE PATIENT RETURNED HOME. ON THE (B)(6) 2026 THE PATIENT REPORTED HER SYMPTOMS HAD RETURNED AND A BLISTER HAD FORMED ON THE UPPER LIP. THE PATIENT WAS SENT FOR AN ULTRASOUND. THE HCP STATED THE ULTRASOUND SHOWED THE VASCULAR OCCLUSION WAS NOT FULLY RESOLVED. THE HCP INJECTED THE UPPER
Patient problems: Blister; Hematoma; Obstruction/Occlusion; Pain; Pallor; Skin Discoloration
MAUDE report 24967511 ↗InjuryApr 14, 2026Adverse Event Without Identified Device or Use Problem
ON (B)(6) 2026, THE HCP REPORTED INJECTING 1 ML OF EVOLYSSE SMOOTH SUPERFICIALLY INTO THE SKIN AROUND THE MOUTH OF A PATIENT, USING THE PROVIDED 30-GAUGE NEEDLE. IMMEDIATELY FOLLOWING THE INJECTION, THE PATIENT EXPERIENCED DISCOLORATION IN THE LEFT ORAL COMMISSURE WITHOUT PAIN. THE HCP INJECTED THE AREA WITH 7 VIALS OF HYALURONIDASE, SYMPTOMS IMPROVED, AND CAPILLARY REFILL WAS NORMAL. HCP PRESCRIBED WARM COMPRESS AND MASSAGE. AS OF 10-APR-2026, THE PATIENTS SYMPTOMS HAVE RESOLVED.
Patient problems: Obstruction/Occlusion; Skin Discoloration
MAUDE report 24877541 ↗InjuryApr 14, 2026Adverse Event Without Identified Device or Use Problem
ON (B)(6) 2026, THE HCP REPORTED INJECTING 1 ML OF EVOLYSSE SMOOTH SUPERFICIALLY INTO THE SKIN AROUND THE MOUTH OF A PATIENT, USING THE PROVIDED 30-GAUGE NEEDLE. IMMEDIATELY FOLLOWING THE INJECTION, THE PATIENT EXPERIENCED DISCOLORATION IN THE LEFT ORAL COMMISSURE WITHOUT PAIN. THE HCP INJECTED THE AREA WITH 7 VIALS OF HYALURONIDASE, SYMPTOMS IMPROVED, AND CAPILLARY REFILL WAS NORMAL. HCP PRESCRIBED WARM COMPRESS AND MASSAGE. AS OF (B)(6) 2026, THE PATIENTS SYMPTOMS HAVE RESOLVED.
Patient problems: Obstruction/Occlusion; Skin Discoloration
MAUDE report 24877420 ↗InjuryMar 30, 2026Off-Label Use; Adverse Event Without Identified Device or Use Problem
ON (B)(6) 2026, THE HCP REPORTED INJECTING 0.4CC OF EVOLYSSE SMOOTH INTO THE LIPS OF A PATIENT BY BACKFILLING THE PRODUCT INTO A BD SYRINGE. IMMEDIATELY FOLLOWING THE INJECTION, THE PATIENT EXPERIENCED BLANCHING AND PAIN AT THE WET/DRY BORDER ALONG WITH SIGNIFICANT BRUISING. THE HCP DETERMINED THE SYMPTOMS TO BE CONSISTENT WITH A VASCULAR OCCLUSION AND INJECTED THE PATIENT'S LIPS WITH 1 VIAL OF HYLENEX OVER THREE (3) INJECTIONS. THE AFOREMENTIONED TREATMENT WAS SUCCESSFUL IN TREATING THE VASCULAR OCCLUSION. AS OF (B)(6) 2026, ALL THE PATIENT'S SYMPTOMS HAVE RESOLVED; NO LONG-TERM EFFECTS WERE REPORTED.
Patient problems: Bruise/Contusion; Obstruction/Occlusion; Pain; Pallor
MAUDE report 24736291 ↗InjuryMar 23, 2026Off-Label Use; Adverse Event Without Identified Device or Use Problem
ON (B)(6) 2026, THE HCP REPORTED INJECTING 0.4CC OF EVOLYSSE SMOOTH INTO THE LIPS OF A PATIENT BY BACKFILLING THE PRODUCT INTO A BD SYRINGE. IMMEDIATELY FOLLOWING THE INJECTION, THE PATIENT EXPERIENCED BLANCHING AND PAIN AT THE WET/DRY BORDER ALONG WITH SIGNIFICANT BRUISING. THE HCP DETERMINED THE SYMPTOMS TO BE CONSISTENT WITH A VASCULAR OCCLUSION AND INJECTED THE PATIENT'S LIPS WITH 1 VIAL OF HYLENEX OVER THREE (3) INJECTIONS. THE AFOREMENTIONED TREATMENT WAS SUCCESSFUL IN TREATING THE VASCULAR OCCLUSION. AS OF (B)(6) 2026, ALL THE PATIENT'S SYMPTOMS HAVE RESOLVED; NO LONG TERM EFFECTS WERE REPORTED.
Patient problems: Bruise/Contusion; Obstruction/Occlusion; Pain; Pallor
MAUDE report 24670476 ↗InjuryFeb 4, 2026Off-Label Use; Improper or Incorrect Procedure or Method; Adverse Event Without Identified Device or Use Problem
ON (B)(6), 2025 THE HCP REPORTING INJECTING EVOLYSSE SMOOTH INTO BOTH THE UPPER AND LOWER LIPS OF A PATIENT. BY NOVEMBER 28, 2025, THE PATIENT EXPERIENCED YELLOW CRUSTING ON HER LIPS. THE PATIENT WAS PRESCRIBED ANTIVIRALS WITH NO IMPROVEMENT. SHE WAS THEN PRESCRIBED THE FIRST MEDROL DOES STEROID PACK WITHOUT IMPROVEMENT. THE PATIENT WAS THEN TREATED WITH BACTROBAN (ANTIBIOTIC) AND A SECOND MEDROL STEROIDS DOSE PACK WITHOUT IMPROVEMENT. THE PRODUCT WAS DISSOLVED AND RESULTED IN A SIGNIFICANT IMPROVEMENT TO THE PATIENT. HOWEVER, THE PATIENT IS EXPERIENCING DISCOMFORT DUE TO AN IMPAIRED BARRIER WHICH IS BEING MANAGED WITH GABAPENTIN AND FLEXERIL. THE PATIENT IS EXPERIENCING REFERRED PAIN IN THE JAW AND SENSITIVITY IN THE LIPS. AS OF JANUARY 05, 2026 THE PATIENT'S LIPS HAVE RE-EPITHELIALIZED AND SYMPTOMS ARE IMPROVING. AS OF JANUARY 27, 2026, THE PATIENT HAS FULLY RECOVERED AND IS NO LONGER EXPERIENCING ANY PAIN SYMPTOMS.
Patient problems: Obstruction/Occlusion; Pain; Swelling/ Edema
MAUDE report 24263521 ↗InjuryJan 27, 2026Adverse Event Without Identified Device or Use Problem
THE HEALTHCARE PROFESSIONAL REPORTED INJECTING EVOLYSSE SMOOTH SUBDERMALLY INTO THE CHEEKS OF A PATIENT ON (B)(6) 2025. THE PATIENT EXPERIENCED A HARD, RAISED, AND REDDENED AREA ON THE LEFT CHEEK. ON (B)(6) 2025, THE PATIENT EXPERIENCED A DECREASE IN THE SWELLING BUT THE AREA BECAME TENDER TO THE TOUCH. THEN ON (B)(6) 2025, THE PATIENT WAS DIAGNOSED WITH CELLULITIS AND PRESCRIBED KEFLEX.
Patient problems: Bacterial Infection; Erythema; Local Reaction; Pain; Swelling/ Edema
MAUDE report 24191575 ↗InjuryJan 23, 2026Off-Label Use
ON NOVEMBER 14, 2025, THE HCP REPORTING INJECTING EVOLYSSE SMOOTH INTO BOTH THE UPPER AND LOWER LIPS OF A PATIENT. BY (B)(6) 2025, THE PATIENT EXPERIENCED YELLOW CRUSTING ON HER LIPS. THE PATIENT WAS PRESCRIBED ANTIVIRALS WITH NO IMPROVEMENT. SHE WAS THEN PRESCRIBED THE FIRST MEDROL DOES STEROID PACK WITHOUT IMPROVEMENT. THE PATIENT WAS THEN TREATED WITH BACTROBAN (ANTIBIOTIC) AND A SECOND MEDROL STEROIDS DOSE PACK WITHOUT IMPROVEMENT. THE PRODUCT WAS DISSOLVED AND RESULTED IN A SIGNIFICANT IMPROVEMENT TO THE PATIENT. HOWEVER, THE PATIENT IS EXPERIENCING DISCOMFORT DUE TO AN IMPAIRED BARRIER WHICH IS BEING MANAGED WITH GABAPENTIN AND FLEXERIL. THE PATIENT IS EXPERIENCING REFERRED PAIN IN THE JAW AND SENSITIVITY IN THE LIPS. AS OF (B)(6) 2026, THE PATIENT'S LIPS HAVE RE-EPITHELIALIZED AND SYMPTOMS ARE IMPROVING.
Patient problems: Obstruction/Occlusion; Pain; Swelling/ Edema
MAUDE report 24171772 ↗InjuryJan 6, 2026Adverse Event Without Identified Device or Use Problem
THE HEALTHCARE PROFESSIONAL INJECTED EVOLYSSE SMOOTH SUBDERMALLY INTO A FEMALE PATIENT'S CHEEKS ON (B)(6) 2025. BY (B)(6) 2025, THE PATIENT DEVELOPED A SWOLLEN, PINK, AND TENDER AREA ON HER LEFT CHEEK. SHE CONSULTED A DIFFERENT DERMATOLOGIST AND WAS DIAGNOSED WITH CELLULITIS, FOR WHICH SHE RECEIVED A SEVEN-DAY COURSE OF KEFLEX. AFTER COMPLETING THE MEDICATION ON (B)(6) 2026, THE AFFECTED AREA FELT FIRM. ON (B)(6) 2026, THE AREA WAS TREATED WITH A 0.5ML INJECTION OF HYLENEX; AT THE PATIENT'S REQUEST, ANOTHER 1ML WAS INJECTED THE FOLLOWING DAY. BY (B)(6) 2026, THE FIRMNESS HAD MOVED LOWER ON HER LEFT CHEEK, PROMPTING ANOTHER 1ML INJECTION OF HYLENEX. AN INCONCLUSIVE CT SCAN WAS REPORTED ON (B)(6) 2026. THE PRIMARY CARE PHYSICIAN ADVISED DISCONTINUING PRODUCT DISSOLUTION AND PRESCRIBED ANOTHER ROUND OF KEFLEX. UPDATED PHOTOS SENT BY THE PROVIDER AFTER THE SECOND KEFLEX COURSE SHOWED THAT THE SWELLING AND REDNESS HAD RESOLVED AS OF (B)(6) 2026.
Patient problems: Bacterial Infection
MAUDE report 23979410 ↗InjuryDec 12, 2025Off-Label Use; Off-Label Use
ON (B)(6) 2025, A HEALTHCARE PROFESSIONAL INJECTED 1CC OF EVOLYSSE SMOOTH INTO A PATIENT'S LIPS. ON (B)(6) 2025, THE PATIENT RECEIVED INJECTIONS OF TIRZEPATIDE AND VITAMIN B3, AFTER WHICH THEY EXPERIENCED SWELLING AT THE INJECTION SITE, AS WELL AS LIP SWELLING AND TINGLING. THAT SAME DAY, THE HEALTHCARE PROVIDER REFERRED THE PATIENT TO THE EMERGENCY ROOM (ER), WHERE TREATMENT INCLUDED INTRAVENOUS EPINEPHRINE AND STEROIDS, FOLLOWED BY A 10-DAY COURSE OF ORAL STEROIDS. ON (B)(6) 2025, THE FINAL DAY OF ORAL STEROIDS, THE PATIENT AGAIN HAD SWOLLEN LIPS. THE PATIENT VISITED THEIR PRIMARY CARE PROVIDER (PCP) ON (B)(6) 2025, WAS PRESCRIBED ORAL STEROIDS, AND REFERRED TO AN ALLERGIST. THE PATIENT'S LIP SWELLING SUBSIDED ONCE ORAL STEROIDS WERE RE-STARTED.
Patient problems: Burning Sensation; Hypersensitivity/Allergic reaction; Swelling/ Edema
MAUDE report 23789359 ↗InjuryDec 9, 2025Off-Label Use; Off-Label Use
ON (B)(6) 2025, A HEALTHCARE PROFESSIONAL INJECTED 1CC OF EVOLYSSE SMOOTH INTO A PATIENT'S LIPS. ON (B)(6) 2025, THE PATIENT RECEIVED INJECTIONS OF TIRZEPATIDE AND VITAMIN B3, AFTER WHICH THEY EXPERIENCED SWELLING AT THE INJECTION SITE, AS WELL AS LIP SWELLING AND TINGLING. THAT SAME DAY, THE HEALTHCARE PROVIDER REFERRED THE PATIENT TO THE EMERGENCY ROOM (ER), WHERE TREATMENT INCLUDED INTRAVENOUS EPINEPHRINE AND STEROIDS, FOLLOWED BY A 10-DAY COURSE OF ORAL STEROIDS. ON (B)(6) 2025, THE FINAL DAY OF ORAL STEROIDS, THE PATIENT AGAIN HAD SWOLLEN LIPS. THE PATIENT VISITED THEIR PRIMARY CARE PROVIDER (PCP) ON (B)(6) 2025, WAS PRESCRIBED ORAL STEROIDS, AND REFERRED TO AN ALLERGIST. THE PATIENT'S LIP SWELLING SUBSIDED ONCE ORAL STEROIDS WERE RE-STARTED.
Patient problems: Burning Sensation; Hypersensitivity/Allergic reaction; Swelling/ Edema
MAUDE report 23759400 ↗InjuryNov 21, 2025Off-Label Use; Off-Label Use
THE HEALTHCARE PROVIDER REPORTED INJECTING 0.2CC OF EVOLYSSE SMOOTH INTO BOTH SIDES OF THE UPPER LIP USING THE MANUFACTURER PROVIDED NEEDLE. IMMEDIATELY FOLLOWING THE PROCEDURE ON (B)(6) 2025, THE PATIENT EXPERIENCED ASYMMETRICAL UPPER LIP EDEMA WITHOUT PAIN. THE CAPILLARY REFILL WAS NORMAL.
Patient problems: Local Reaction
MAUDE report 23620937 ↗InjuryNov 21, 2025Off-Label Use; Improper or Incorrect Procedure or Method; Off-Label Use; Improper or Incorrect Procedure or Method
A HEALTHCARE PROFESSIONAL REPORTED INJECTING 0.8ML OF EVOLYSSE SMOOTH INTO THE UPPER AND LOWER LIPS OF A PATIENT. APPROXIMATELY 8 WEEKS POST INJECTION, THE PATIENT EXPERIENCED LUMPS. THE HCP DISSOLVED THE LUMPS WITH HYALURONIDASE WITH SOME DIFFICULTY. THE MANUFACTURER PROVIDED SYRINGE WAS NOT USED.
Patient problems: Inflammation; Nodule
MAUDE report 23620920 ↗InjuryOct 31, 2025No Apparent Adverse Event; No Apparent Adverse Event
THE HEALTHCARE PROVIDER REPORTED INJECTING A PATIENT WITH EVOLYSSE SMOOTH IN AND AROUND THE LIPS, PERIORAL LINES, AND BROWS. APPROXIMATELY ONE (1) WEEK POST INJECTION, THE PATIENT EXPERIENCED INDURATION AND SWELLING/INFLAMMATION AT ALL INJECTION SITES. THE HCP TREATED THE INDURATION WITH 30 UNITS OF HYALURONIDASE IN AREAS OF INJECTION SWELLING/IRIRITATION; HOWEVER, THE INFAMMATION/SWELLING PERSISTED.
Patient problems: Local Reaction
MAUDE report 23441953 ↗
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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