AVAflex 1025011000Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 07613327374612), received between Jul 21, 2021 and Apr 22, 2026 — classified as 3 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Fracture” (10 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 22, 2026Fracture

  THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. EVENTS OCCURRED BETWEEN JANUARY 1 ¿ MARCH 31 2026. THIS REPORT SUMMARIZES 1 EVENT FOR THE FAILURE: FRACTURE. - 1 EVENT HAD NO HEALTH CONSEQUENCES OR IMPACT.

  Patient problems: Foreign Body In Patient

  MAUDE report 24954297 ↗
• MalfunctionOct 23, 2025Fracture; Fracture

  THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. EVENTS OCCURRED BETWEEN(B)(6) 2025. THIS REPORT SUMMARIZES 1 EVENT FOR THE FAILURE: FRACTURE. - 1 EVENT HAD NO HEALTH CONSEQUENCES OR IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23368537 ↗
• MalfunctionApr 21, 2025Fracture; Fracture

  THIS REPORT SUMMARIZES 2 MALFUNCTION EVENTS IN WHICH THE DEVICE OR CUTTING ACCESSORY FRACTURED. 2 EVENTS HAD PATIENT INVOLVEMENT: NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21876663 ↗
• InjuryFeb 5, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE 11G ACCESS CANNULA WAS ADVANCING THROUGH HARD BONE WHILE USING A LOT OF FORCE. IT WAS DISCOVERED THE 11G ACCESS CANNULA HAD SHEARED OFF AT THE DISTAL END. THE DOCTOR TRIED TO REMOVE IT AND ENDED UP SENDING THE PATIENT TO A NEURO SURGEON TO REMOVE THE REMAINING PORTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21312323 ↗
• InjuryNov 6, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING THE PROCEDURE THE DOCTOR WAS HAVING A DIFFICULT TIME REMOVING THE AVAFLEX DEVICE WHICH LEAD TO THE HANDLE SNAPPING OFF. THE AVAFLEX WAS CUT JUST UNDER THE SKIN AND IMPLANTED WITH CEMENT. PER THE DOCTOR THE PATIENT WILL NEED A REVISION SURGERY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: Foreign Body In Patient

  MAUDE report 20621696 ↗
• MalfunctionOct 21, 2024Fracture; Fracture

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE OR CUTTING ACCESSORY FRACTURED. - 1 EVENT HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20500723 ↗
• InjuryAug 30, 2024No Apparent Adverse Event; Insufficient Device Problem Information; No Apparent Adverse Event; Insufficient Device Problem Information

  IT WAS ORIGINALLY REPORTED THAT DURING AN ABLATION PROCEDURE, THE PATIENT SUSTAINED SEVERAL SMALL BURNS AND A SECOND DEGREE BURN TO THE CALF WHERE THE GROUNDING PAD WAS PLACED. IT WAS REPORTED THE PATIENT REQUIRED A SKIN GRAFT TO REPAIR THE BURNS. UPON FURTHER INVESTIGATION AND CUSTOMER FEEDBACK, IT WAS DETERMINED THAT THIS PRODUCT WAS NOT INVOLVED IN THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Partial thickness (Second Degree) Burn

  MAUDE report 20109226 ↗
• MalfunctionJan 22, 2024Fracture; Fracture

  THIS REPORT SUMMARIZES 2 MALFUNCTION EVENTS IN WHICH THE DEVICE OR CUTTING ACCESSORY FRACTURED. - 2 EVENTS HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18557275 ↗
• MalfunctionOct 23, 2023Fracture; Fracture

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE OR CUTTING ACCESSORY FRACTURED. 1 EVENT HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17987909 ↗
• MalfunctionJan 29, 2023Fracture; Fracture

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE OR CUTTING ACCESSORY FRACTURED. - 1 EVENT HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16261865 ↗
• MalfunctionJul 21, 2021Fracture; Fracture

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE OR CUTTING ACCESSORY FRACTURED. 1 EVENT HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12204232 ↗