Tenex Health TX® 554-2003-001Recalls & reported problems

Summary

The FDA's MAUDE database contains 213 adverse event reports that list this exact device (DI 00857156006154), received between Aug 20, 2020 and Sep 24, 2026 — classified as 14 injuries, 199 malfunctions.

The most frequently reported specific device problem is “Fracture” (203 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. 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 25 most recent of 213 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2026Fracture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50892216 ↗
• MalfunctionMay 13, 2026Fracture

  DURING A PROCEDURE WITH THE TENEX SYSTEM, A PORTION OF THE MICROTIP NEEDLE SEPARATED FROM THE REST OF THE HANDPIECE. 2 ADDITIONAL HANDPIECES WERE USED TO COMPLETE THE PROCEDURE, BOTH REMAINED INTACT. AN X-RAY WAS PERFORMED AND CONFIRMED NOTHING WAS RETAINED IN THE PATIENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25166513 ↗
• MalfunctionMar 14, 2026Fracture

  DURING A PROCEDURE WITH THE TENEX SYSTEM, A PORTION OF THE MICROTIP NEEDLE SEPARATED FROM THE REST OF THE HANDPIECE. THE PIECE WAS RETRIEVED FROM THE PATIENT, AND AN ULTRASOUND CONFIRMED NO FOREIGN BODY WAS LEFT BEHIND. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24599721 ↗
• MalfunctionFeb 26, 2026Fracture

  DURING A PROCEDURE WITH THE TENEX SYSTEM, THERE WERE 2 INSTANCES OF A PORTION OF THE MICROTIP NEEDLE SEPARATING FROM THE REST OF THE HANDPIECE. ANOTHER HANDPIECE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24464658 ↗
• MalfunctionFeb 20, 2026Fracture

  DURING A PROCEDURE WITH THE TENEX SYSTEM, A PORTION OF THE MICROTIP NEEDLE SEPARATED FROM THE REST OF THE HANDPIECE. ANOTHER HANDPIECE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24408191 ↗
• MalfunctionFeb 20, 2026Fracture

  DURING A PROCEDURE WITH THE TENEX SYSTEM, A PORTION OF THE MICROTIP NEEDLE SEPARATED FROM THE REST OF THE HANDPIECE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24408187 ↗
• MalfunctionFeb 13, 2026Fracture

  DURING A PROCEDURE WITH THE TENEX SYSTEM, A PORTION OF THE MICROTIP NEEDLE SEPARATED FROM THE REST OF THE HANDPIECE. ULTRASOUND CONFIRMED NOTHING WAS RETAINED IN THE PATIENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24339921 ↗
• MalfunctionFeb 13, 2026Fracture

  DURING A PROCEDURE WITH THE TENEX SYSTEM, A PORTION OF THE MICROTIP NEEDLE SEPARATED FROM THE REST OF THE HANDPIECE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24339838 ↗
• MalfunctionFeb 13, 2026Fracture

  DURING A PROCEDURE WITH THE TENEX SYSTEM, A PORTION OF THE MICROTIP NEEDLE SEPARATED FROM THE REST OF THE HANDPIECE. A MANUAL TENOTOMY WITH A 18G SPINAL NEEDLE WAS THEN COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24339826 ↗
• InjuryFeb 5, 2026Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IN THE ARTICLE "MINIMALLY INVASIVE ULTRASOUND-GUIDED PERCUTANEOUS PLANTAR FASCIOTOMY ON CHRONIC PLANTAR FASCIITIS: A RETROSPECTIVE ANALYSIS" BY ENCINAS ET AL., 2 CASES OF DELAYED WOUND HEALING AND 2 CASES OF BAXTER'S NERVE ENTRAPMENT WERE REPORTED IN PATIENTS WHO UNDERWENT A PLANTAR FASCIITIS PROCEDURE WITH THE TX SYSTEM. ALL 4 ADVERSE EVENTS REQUIRED ADDITIONAL INTERVENTION TO TREAT. PATIENTS WITH DELAYED WOUND HEALING WERE TREATED WITH LOCAL WOUND CARE AND ORAL ANTIBIOTICS. PATIENTS WITH BAXTER'S NERVE ENTRAPMENT UNDERWENT BAXTER'S NERVE DECOMPRESSION, WHICH WAS PERFORMED MORE THAN A YEAR AFTER THE INITIAL TX SYSTEM PROCEDURE. THESE ADVERSE EVENTS ARE SUMMARIZED IN THIS FORM 3500A.

  Patient problems: Impaired Healing; Neuropathy

  MAUDE report 24273614 ↗
• MalfunctionDec 18, 2025Fracture; Fracture

  DURING A PROCEDURE WITH THE TENEX SYSTEM, A PORTION OF THE MICROTIP NEEDLE SEPARATED FROM THE REST OF THE HANDPIECE. ANOTHER HANDPIECE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23846117 ↗
• MalfunctionDec 18, 2025Fracture; Fracture

  DURING A PROCEDURE WITH THE TENEX SYSTEM, A PORTION OF THE MICROTIP NEEDLE SEPARATED FROM THE REST OF THE HANDPIECE. ANOTHER HANDPIECE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23846116 ↗
• MalfunctionDec 9, 2025Fracture; Fracture

  DURING A PROCEDURE WITH THE TENEX SYSTEM, A PORTION OF THE MICROTIP NEEDLE SEPARATED FROM THE REST OF THE HANDPIECE. A DIAGNOSTIC ULTRASOUND WAS PERFORMED AND CONFIRMED THAT NOTHING WAS RETAINED IN THE PATIENT. ANOTHER HANDPIECE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23759097 ↗
• MalfunctionNov 21, 2025Fracture; Fracture

  DURING A PODIATRY PROCEDURE WITH THE TENEX SYSTEM, A PORTION OF THE MICROTIP NEEDLE SEPARATED FROM THE REST OF THE HANDPIECE WHEN THE HANDPIECE WAS REMOVED FROM THE PATIENT. AN X-RAY WAS PERFORMED AND CONFIRMED THAT NOTHING WAS RETAINED IN THE PATIENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23619175 ↗
• MalfunctionOct 28, 2025Overheating of Device; Overheating of Device

  SHORTLY AFTER THE START OF A PROCEDURE WITH THE TENEX SYSTEM, THE SURGEON REPORTED FEELING THE HANDPIECE OVERHEAT IN THEIR HAND. ANOTHER HANDPIECE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23407761 ↗
• MalfunctionOct 22, 2025Fracture; Fracture

  AT THE START OF A PROCEDURE WITH THE TENEX SYSTEM, A PORTION OF THE MICROTIP NEEDLE SEPARATED FROM THE REST OF THE HANDPIECE AND ANOTHER HANDPIECE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23360781 ↗
• MalfunctionOct 17, 2025Fracture; Fracture

  TOWARDS THE END OF A PROCEDURE WITH THE TENEX SYSTEM, A PORTION OF THE MICROTIP NEEDLE SEPARATED FROM THE REST OF THE HANDPIECE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23330606 ↗
• MalfunctionOct 17, 2025Fracture; Fracture

  TOWARDS THE END OF A PROCEDURE WITH THE TENEX SYSTEM, A PORTION OF THE MICROTIP NEEDLE SEPARATED FROM THE REST OF THE HANDPIECE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23330565 ↗
• MalfunctionSep 16, 2025Fracture; Fracture

  DURING A PROCEDURE WITH THE TENEX SYSTEM, A PORTION OF THE MICROTIP NEEDLE SEPARATED FROM THE REST OF THE HANDPIECE AND ANOTHER HANDPIECE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23064459 ↗
• MalfunctionSep 4, 2025Fracture; Fracture

  DURING A PROCEDURE WITH THE TENEX SYSTEM, A PORTION OF THE MICROTIP NEEDLE SEPARATED FROM THE REST OF THE HANDPIECE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22973635 ↗
• MalfunctionAug 25, 2025Fracture; Fracture

  DURING A PROCEDURE WITH THE TENEX SYSTEM, A PORTION OF THE MICROTIP NEEDLE SEPARATED FROM THE REST OF THE HANDPIECE AND ANOTHER HANDPIECE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22890405 ↗
• MalfunctionAug 20, 2025Fracture; Fracture

  DURING A PROCEDURE WITH THE TENEX SYSTEM, A PORTION OF THE MICROTIP NEEDLE SEPARATED FROM THE REST OF THE HANDPIECE AND ANOTHER HANDPIECE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22856699 ↗
• MalfunctionAug 18, 2025Fracture; Fracture

  DURING A PROCEDURE WITH THE TENEX SYSTEM, A PORTION OF THE MICROTIP NEEDLE SEPARATED FROM THE REST OF THE HANDPIECE AND ANOTHER HANDPIECE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22833070 ↗
• MalfunctionAug 11, 2025Fracture; Fracture

  DURING A PROCEDURE WITH THE TENEX SYSTEM, A PORTION OF THE MICROTIP NEEDLE SEPARATED FROM THE REST OF THE HANDPIECE AND ANOTHER HANDPIECE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22772418 ↗
• MalfunctionAug 4, 2025Fracture; Fracture

  DURING A PROCEDURE WITH THE TENEX SYSTEM, A PORTION OF THE MICROTIP NEEDLE SEPARATED FROM THE REST OF THE HANDPIECE AND ANOTHER HANDPIECE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22710064 ↗