Tenex Health TX® 554-1003-001Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00857156006215), received between Aug 14, 2020 and Mar 13, 2026 — classified as 6 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Fracture” (16 reports).

1 other recall cover devices cleared under the same FDA submission (K123640); they may or may not involve this specific model.

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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 13, 2026Fracture

  AFTER A PROCEDURE WITH THE TENEX SYSTEM, IT WAS DISCOVERED THAT A PORTION OF THE MICROTIP NEEDLE HAD SEPARATED FROM THE REST OF THE HANDPIECE. THE PIECE WAS RETRIEVED FROM THE PATIENT, AND AN ULTRASOUND CONFIRMED NO FOREIGN BODIES REMAINED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND NO FURTHER TREATMENT NEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24596230 ↗
• MalfunctionOct 27, 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 23392158 ↗
• 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 23330660 ↗
• InjuryOct 15, 2025Fracture; Fracture

  A PATIENT REPORTED PAIN AND OBSERVED A RETAINED PORTION OF THE MICROTIP NEEDLE EMERGING FROM THEIR FOOT 4-6 WEEKS FOLLOWING A PROCEDURE WITH THE TENEX SYSTEM (APPROXIMATELY BETWEEN (B)(6) 2025). PATIENT EXTRACTED THE NEEDLE UNDER DIRECTION FROM THEIR DOCTOR AND IS EXPECTED TO FOLLOW UP WITH THE DOCTOR.

  Patient problems: Foreign Body In Patient; Pain

  MAUDE report 23297041 ↗
• MalfunctionAug 29, 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 22929261 ↗
• MalfunctionMar 19, 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 21649440 ↗
• MalfunctionNov 17, 2023Fracture; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18166379 ↗
• MalfunctionNov 17, 2023Fracture; Fracture

  DURING A PROCEDURE WITH THE TENEX SYSTEM, THE MICROTIP NEEDLE SEPARATED FROM THE REST OF THE HAND PIECE. THIS OCCURRED TWICE IN THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED WITH ANOTHER HAND PIECE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18165258 ↗
• MalfunctionNov 15, 2023Fracture; Fracture

  DURING A PROCEDURE WITH THE TENEX SYSTEM, THE MICROTIP NEEDLE SEPARATED FROM THE REST OF THE HAND PIECE. THE PROCEDURE WAS COMPLETED WITH ANOTHER HAND PIECE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18145671 ↗
• MalfunctionNov 7, 2023Fracture; Fracture

  DURING A PROCEDURE WITH THE TENEX SYSTEM, THE MICROTIP NEEDLE SEPARATED FROM THE REST OF THE HAND PIECE AND WAS REMOVED FROM THE TREATMENT SITE. X-RAY IMAGING WAS USED IN REMOVING THE TIP. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18088577 ↗
• MalfunctionSep 26, 2023Fracture; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17821852 ↗
• MalfunctionDec 6, 2022Fracture; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15927909 ↗
• InjuryJul 8, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  A USER REPORTED THAT A PATIENT HAD A NUMBER OF SMALL, COLORED "GLASS/ METALLIC" PARTICLES REMOVED FROM THE DERMIS IN THEIR LOWER ACHILLES TENDON AREA, FOLLOWING PAIN IN THE AREA AND IDENTIFICATION OF THE FOREIGN BODIES ON X-RAY AND CT IMAGING. THE PAIN STARTED APPROXIMATELY FOUR WEEKS AFTER A PROCEDURE WITH A TENEX HEALTH TX1 MICROTIP ON THE ACHILLES TENDON. A PATHOLOGY REPORT IDENTIFIED "GLASS PIECES." NO ISSUES WERE REPORTED DURING THE PROCEDURE. THE MICROTIP WAS NOT RETURNED FOR EVALUATION. THE MICROTIP DOES NOT CONTAIN COLORED GLASS MATERIALS. IT IS UNCLEAR WHERE THE PARTICLES ORIGINATED OR HOW THEY WERE DEPOSITED INTO THE DERMIS.

  Patient problems: Foreign Body In Patient; Pain

  MAUDE report 14966736 ↗
• InjuryMay 28, 2021Insufficient Device Problem Information; Appropriate Device Problem Term/Code Not Available; Insufficient Device Problem Information; Appropriate Device Problem Term/Code Not Available

  A PATIENT REPORTED LOSS OF SOME ARM FUNCTION (PRONATION) A YEAR AFTER A PROCEDURE WITH THE TENEX HEALTH TX SYSTEM ON HIS ELBOW. THE TREATING PHYSICIAN DID NOT NOTE ANY ISSUES DURING THE PROCEDURE OR AT POST-OPERATIVE FOLLOW-UP. IT IS UNCLEAR IF THE PRESENT CONDITION IS RELATED TO THE PRIOR TREATMENT WITH THE TX SYSTEM.

  Patient problems: Joint Contracture

  MAUDE report 11904839 ↗
• MalfunctionMay 18, 2021Fracture; Melted; Fracture; Melted

  AT THE BEGINNING OF A PROCEDURE WITH THE TENEX SYSTEM, A PORTION OF THE MICROTIP NEEDLE SEPARATED FROM THE REST OF THE HAND PIECE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11845441 ↗
• InjuryApr 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A LITERATURE REVIEW DISCOVERED AN ARTICLE WHICH DESCRIBED AN ADVERSE EVENT POSSIBLY ASSOCIATED WITH USE OF THE TX SYSTEM (TX1 MICROTIP). THE ARTICLE WAS A SERIES OF CASE REPORTS. ONE CASE REPORTED DEVELOPMENT OF A DEEP VEIN THROMBOSIS IN A PATIENT 3 WEEKS AFTER TREATMENT OF THE ACHILLES TENDON WITH THE TX SYSTEM. ANTICOAGULATION THERAPY WAS ADMINISTERED. NO ADDITIONAL INFORMATION OR FOLLOW-UP WAS PRESENTED.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 11668773 ↗
• MalfunctionApr 8, 2021Fracture; Fracture

  AT THE BEGINNING OF A PROCEDURE WITH THE TENEX SYSTEM, A PORTION OF THE MICROTIP NEEDLE SEPARATED FROM THE REST OF THE HAND PIECE AND WAS RETRIEVED. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11636619 ↗
• InjuryJan 18, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  A PATIENT REPORTED IN A COMMENT ON SOCIAL MEDIA (B)(6) THAT THEY HAD MORE PAIN IN THEIR ELBOW SEVEN WEEKS AFTER TREATMENT WITH A TENEX HEALTH DEVICE THAN BEFORE TREATMENT. THE PATIENT ALSO REPORTED THAT, ONE WEEK AFTER THE ELBOW PROCEDURE WITH THE TENEX HEALTH DEVICE, THEY HAD SIGNIFICANT SHOULDER SURGERY. THE CAUSE OF THE PAIN IS UNCLEAR, AS IS THE RELATIONSHIP BETWEEN THE PAIN AND THE SHOULDER SURGERY.

  Patient problems: Pain

  MAUDE report 11190518 ↗
• InjuryJan 7, 2021Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  A PHYSICIAN REPORTED THAT THE MICROTIP PROBE CONTINUED TO SPRAY SALINE IRRIGATION FLUID AFTER THE SYSTEM FOOT PEDAL WAS NO LONGER DEPRESSED. A WELT DEVELOPED OVER THE OPERATIVE SITE IN THE PATIENT, THAT THE PHYSICIAN WAS UNABLE TO ASPIRATE.

  Patient problems: Wheal(s)

  MAUDE report 11137157 ↗
• MalfunctionDec 16, 2020Fracture; Overheating of Device; Fracture; Overheating of Device

  AT THE END OF A PROCEDURE WITH THE TENEX SYSTEM, A PORTION OF THE MICROTIP NEEDLE SEPARATED FROM THE REST OF THE HAND PIECE. IT WAS ALSO REPORTED THAT THE CASE NOSE PLASTIC ON THE MICROTIP APPEARED TO BE MELTED. THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11021142 ↗
• MalfunctionAug 14, 2020Fracture; Fracture

  DURING A PROCEDURE WITH THE TENEX SYSTEM, A PORTION OF THE MICROTIP NEEDLE SEPARATED FROM THE REST OF THE HAND PIECE. THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10410930 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K123640. One submission often covers many models, so check the product and lot details in each record.

• Z-1552-2014 · Apr 14, 2014 · Terminated
  TX1 Tissue Removal System. TX1 Procedure Pack P/N 554-1003-001 (outer box), TX1 MicroTip P/N 554-1002-001 (inner tray). For use with the TX System Console as an ultrasonic surgica