Tenex Health TX® 554-3003-001Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 00857156006093), received between Aug 12, 2020 and Jun 24, 2026 — classified as 15 injuries, 9 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. 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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 24, 2026Fracture

  DURING A PROCEDURE WITH THE TENEX SYSTEM, A PORTION OF THE MICROTIP NEEDLE SEPARATED FROM THE REST OF THE HANDPIECE. THE PHYSICIAN EXPANDED THE INITIAL INCISION SITE AND RETRIEVED THE SEPARATED PIECE FROM THE PATIENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25612734 ↗
• InjuryFeb 5, 2026Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IN THE ARTICLE "RATIONALE AND TECHNIQUE FOR SUBULCER ULTRASONIC TREATMENT OF HARD-TO-HEAL DIABETIC FOOT ULCERS" BY FREED ET AL,, 20 COMPLICATIONS WERE REPORTED IN PATIENTS WHO UNDERWENT A DIABETIC FOOT ULCER (DFU) PROCEDURE WITH THE TX SYSTEM. EXCERPT FROM THE ARTICLE, "COMPLICATIONS OCCURRED IN 20 PATIENTS (INFECTION: 8; CELLULITIS: 5; CHRONIC PAIN: 3; AMPUTATION: 2; BLISTER FORMATION: 2)". OF THE 20 COMPLICATIONS REPORTED, MDRS WERE PREVIOUSLY SUBMITTED FOR 9 ADVERSE EVENTS (8 INFECTION AND 1 CELLULITIS) AND ARE LISTED IN SECTION H10 . THIS FREED ARTICLE INCLUDES REVIEW OF THE SAME DATA SET THAT WAS REVIEWED AND PRESENTED PREVIOUSLY (BUT WITHOUT DISCUSSION OF ALL AES). THE REMAINING 11 CASES WERE NOT PREVIOUSLY KNOWN TO TENEX HEALTH AND ARE SUMMARIZED IN THIS FORM 3500A: 4 CELLULITIS, 3 CHRONIC PAIN, 2 AMPUTATIONS, AND 2 BLISTER FORMATIONS.

  Patient problems: Blister; Cellulitis; Pain

  MAUDE report 24273618 ↗
• InjuryOct 17, 2025Fracture; Fracture

  DURING A PROCEDURE WITH THE TENEX SYSTEM, A PORTION OF THE MICROTIP NEEDLE SEPARATED FROM THE REST OF THE HAND PIECE. A CT SCAN WAS PERFORMED ON THE PATIENT WITH PLANS TO REMOVE THE FRAGMENT, HOWEVER, THE PATIENT OPTED TO NOT PURSUE SURGICAL INTERVENTION AT THIS TIME. THERE WERE NO ADDITIONAL COMPLICATIONS REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 23330710 ↗
• InjurySep 11, 2025Overheating of Device; Overheating of Device

  DURING A PROCEDURE WITH THE TENEX SYSTEM, THE PHYSICIAN NOTICED A BURNING ODOR COMING FROM INSIDE THE TREATMENT AREA. THE DEVICE WAS REMOVED AND SHOWED BURNED MARKS ON THE TIP OF THE DEVICE, BUT NO SKIN BURN WAS OBSERVED ON THE PATIENT.

  Patient problems: Burn(s)

  MAUDE report 23033730 ↗
• MalfunctionDec 5, 2024Fracture; 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20859387 ↗
• InjuryOct 5, 2023Temperature Problem; Temperature Problem

  A PATIENT REPORTED THROUGH THE FDA MEDWATCH PROGRAM THAT THEY HAD EXPERIENCED A THERMAL BURN AND AN INFECTION FOLLOWING A PROCEDURE WITH A TENEX HEALTH TX SYSTEM DEVICE. SYMPTOMS MANIFESTED FIVE DAYS POSTOPERATIVELY AND INCLUDED PAIN, SWELLING, REDNESS AND AN INABILITY TO BEAR WEIGHT ON THE OPERATIVE FOOT.

  Patient problems: Ambulation or Postural Difficulties; Bacterial Infection; Erythema; Pain; Superficial (First Degree) Burn; Swelling/ Edema

  MAUDE report 17881609 ↗
• MalfunctionSep 20, 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 17786473 ↗
• MalfunctionApr 28, 2023Fracture; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16834116 ↗
• MalfunctionApr 27, 2023Fracture; 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16828237 ↗
• InjuryMay 26, 2022Use of Device Problem; Use of Device Problem

  A PHYSICIAN HAD TWO PATIENTS FROM TWO DIFFERENT PROCEDURES PERFORMED ON THE SAME DAY, USING THE TENEX HEALTH TX SYSTEM, DEVELOP INFECTIONS AT THE TREATMENT SITES. THE PROCEDURES WERE PERFORMED ON THE ACHILLES TENDON. (DIFFERENT DISPOSABLE TX HANDPIECES WERE USED ON EACH PATIENT). PATIENTS WERE TREATED IN THE HOSPITAL FOR THE INFECTIONS. THE PHYSICIAN DID NOT REPORT ANY ISSUES WITH THE DEVICE OR PATIENTS DURING THE PROCEDURES. THE INFECTIONS DEVELOPED SOME TIME AFTER THE PROCEDURES. IT IS UNCLEAR IF THE INFECTIONS WERE DIRECTLY RELATED TO USE OF THE TX SYSTEM.

  Patient problems: Unspecified Infection

  MAUDE report 14519574 ↗
• InjuryMay 26, 2022Overheating of Device; Overheating of Device

  DURING A PROCEDURE USING THE TX MICROTIP, SMOKE WAS VISIBLE FROM THE NEEDLE INSERTION POINT. THE DEVICE WAS REMOVED FROM THE PATIENT AND A SKIN BURN WAS NOTED. BURN AND PAIN TREATMENTS WERE ADMINISTERED TO TREAT THE PATIENT.

  Patient problems: Burn(s)

  MAUDE report 14519427 ↗
• InjuryDec 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A USER REPORTED THAT A PATIENT DEVELOPED AN INFECTION SOMETIME AFTER TREATMENT WITH A TENEX HEALTH DEVICE. THE CAUSE OF THE INFECTION IS UNCLEAR. THE USER DID NOT IMPLY THAT THE INFECTION WAS DUE TO THE DEVICE OR TREATMENT. HE NOTED THAT IT COULD BE DUE TO PATIENT COMPLIANCE OR POST-PROCEDURE CARE. THE PATIENT WAS TREATED WITH ANTIBIOTICS.

  Patient problems: Unspecified Infection

  MAUDE report 13115450 ↗
• InjuryDec 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A USER REPORTED THAT A PATIENT DEVELOPED AN INFECTION SOMETIME AFTER TREATMENT WITH A TENEX HEALTH DEVICE. THE CAUSE OF THE INFECTION IS UNCLEAR. THE USER DID NOT IMPLY THAT THE INFECTION WAS DUE TO THE DEVICE OR TREATMENT. HE NOTED THAT IT COULD BE DUE TO PATIENT COMPLIANCE OR POST-PROCEDURE CARE. THE PATIENT WAS TREATED WITH ANTIBIOTICS.

  Patient problems: Unspecified Infection

  MAUDE report 13115436 ↗
• InjuryMar 19, 2021Temperature Problem; Temperature Problem

  A PATIENT DEVELOPED A SUPERFICIAL SKIN BURN FOLLOWING A KNEE PROCEDURE WITH THE TX SYSTEM AND A TXB MICROTIP. THE TREATING PHYSICIAN EXPERIENCED EXCESSIVE OCCLUSIONS OF THE ASPIRATION DURING THE CASE AN OBSERVED THE HANDPIECE TO BE OVERHEATING. THE PROCEDURE WAS INTERRUPTED BY THE EVENT. A DRESSING WAS APPLIED TO THE BURN SITE, AND IT APPARENTLY HEALED NORMALLY. NO COMPLICATIONS FROM THE BURN WERE NOTED AT PATIENT FOLLOW-UP 1 WEEK AFTER THE PROCEDURE. THE PATIENT STILL REQUIRED FINAL TREATMENT FOR THE INITIAL PRESENTING CONDITION, HOWEVER, DUE TO THE PROCEDURE INTERRUPTION.

  Patient problems: Burn(s)

  MAUDE report 11532560 ↗
• InjuryJan 29, 2021Temperature Problem; Temperature Problem

  USER RAN OUT OF SALINE IRRIGATION DURING A PROCEDURE DUE TO USING A SMALLER THAN SPECIFIED SIZE SALINE BAG (250CC INSTEAD OF 1000CC). THEY REPORTED THE DEVICE WAS OVERHEATING AS A RESULT, AND THE PATIENT DEVELOPED A SUPERFICIAL SKIN BURN AT THE TREATMENT SITE. THE BURN STARTED AS A BLISTER AND WAS HEALING AT 10 DAYS POST-OP. IT WAS REPORTED THAT THE WOUND WAS FULLY CLOSED AND THE PATIENT WAS PAIN-FREE AFTER APPROXIMATELY 14 DAYS. PATIENT MAY BE UNDER OBSERVATION FOR 60 DAYS.

  Patient problems: Burn(s)

  MAUDE report 11249071 ↗
• MalfunctionDec 23, 2020Fracture; Fracture

  DURING A PROCEDURE WITH THE TENEX SYSTEM, A PORTION OF THE MICROTIP NEEDLE SEPARATED FROM THE REST OF THE HAND PIECE. AN OPEN PROCEDURE WAS COMPETED TO REMOVE THE NEEDLE TIP FROM THE PATIENT. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11069782 ↗
• MalfunctionDec 12, 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 10996062 ↗
• InjuryDec 11, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THERE WAS A REPORT OF PATIENT PAIN AND DELAYED HEALING FOLLOWING A PROCEDURE WITH THE TX HEALTH TXB MICROTIP FOR PLANTAR FASCIITIS AND A CALCANEAL BONE SPUR. THE EXACT LEVEL OF PATIENT PAIN OR HEALING AT THE TIME OF REPORT, SEVEN WEEKS AFTER THE PROCEDURE, WAS UNCLEAR. THE PATIENT ALSO HAD AN MRI SCAN FIVE WEEKS AFTER THE PROCEDURE THAT REVEALED THE SHALLOW PLANTAR CAVITY AT THE SITE OF THE BONE SPUR EXCISION WITH SOME ACCOMPANYING EDEMA. NOTE: EDEMA IS A POSSIBLE OUTCOME OF TREATMENT WITH THE TX SYSTEM, BUT IS CONSIDERED A ROUTINE RESPONSE TO TREATMENT (AS IS INDICATED BY A CAUTION STATEMENT IN THE DEVICE INSTRUCTIONS FOR USE).

  Patient problems: Pain

  MAUDE report 10989506 ↗
• MalfunctionNov 18, 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. THE NEEDLE PIECE WAS IDENTIFIED UNDER FLUOROSCOPY AND RETRIEVED FROM THE PATIENT. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10864036 ↗
• InjuryNov 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IN A WEBINAR PRESENTATION, A PHYSICIAN REPORTED A TENDON RUPTURE FOLLOWING A PROCEDURE WITH THE TX SYSTEM. THE PROCEDURE AND RUPTURE WERE OF THE ACHILLES TENDON. THE RUPTURE PRESENTED SIX MONTHS AFTER TREATMENT.

  Patient problems: Rupture

  MAUDE report 10782291 ↗
• InjuryNov 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED BLEEDING AND AN INFECTION FOLLOWING A PROCEDURE WITH THE TX SYSTEM IN A WEBINAR PRESENTATION. THE COMPLICATION OCCURRED AROUND THE OPERATIVE SITE IN THE FOOT OF THE PATIENT. THERE WAS ALSO A REPORT OF RECURRENT CALCIFICATION IN THE TENDON ABOVE THE HEEL SIX MONTHS AFTER TREATMENT. THE PROCEDURE WAS PERFORMED BY A DIFFERENT PHYSICIAN THAN THE ONE WHO PRESENTED THE WEBINAR.

  Patient problems: Unspecified Infection

  MAUDE report 10782043 ↗
• InjuryOct 29, 2020Temperature Problem; Temperature Problem

  REPORT OF A THERMAL BURN FOLLOWING A PROCEDURE WITH A TXB MICROTIP WAS DISCOVERED IN A WEBINAR PRESENTED BY A PHYSICIAN. THE PHYSICIAN REPORTED THAT THE INJURY OCCURRED IN A PROCEDURE PERFORMED BY A DIFFERENT PHYSICIAN. THE PHYSICIAN USED THE TXB MICROTIP TO TREAT A CHRONIC NONUNION TALAR SPUR. A THERMAL BURN AND OPENED BLISTER WERE EVIDENT ON DAY 2 AFTER THE PROCEDURE. SHARP DEBRIDEMENT WAS USED TO REMOVE NECROTIC TISSUE. THEN AQUACEL FOAM DRESSING WAS APPLIED TO THE BURN SITE. THE BURN PROCEEDED TO HEAL.

  Patient problems: Burn(s)

  MAUDE report 10759983 ↗
• MalfunctionOct 13, 2020Fracture; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10673925 ↗
• InjuryAug 12, 2020Overheating of Device; Use of Device Problem; Overheating of Device; Use of Device Problem

  A PATIENT DEVELOPED A WOUND BREAKDOWN, WITH DELAYED HEALING, THREE WEEKS AFTER A PROCEDURE WITH THE TX SYSTEM. IT APPEARED TO BE A POST-PROCEDURE INFECTION. THE EXACT CAUSE OF THE BREAKDOWN IS UNCLEAR. THE PATIENT'S HEALING ABILITY AND CIRCULATION IN THE LEG MAY HAVE BEEN COMPROMISED. NO PATIENT INJURY OR COMPLICATIONS WERE EVIDENT IMMEDIATELY AFTER THE PROCEDURE OR AT THE ONE-WEEK FOLLOW-UP. SOME REDDENING OF THE SKIN WAS SEEN AT TWO WEEKS. BUT, OVERHEATING OF THE MICROTIP DURING THE PROCEDURE MAY HAVE POTENTIALLY CONTRIBUTED TO THE CONDITION. HOWEVER, THE EXTENT OF THE LESION WAS FAR BEYOND THE POSSIBLE ZONE OF LOCAL THERMAL DAMAGE. PROBE PLACEMENT AND USE SUBCUTANEOUSLY, WITH TISSUE EMBEDDING AND BLOCKAGE OF THE IRRIGATION, COULD HAVE ALSO POTENTIALLY CONTRIBUTED TO THE CONDITION.

  Patient problems: Post Operative Wound Infection; Skin Irritation

  MAUDE report 10399800 ↗