TULARecalls & reported problems across all models

We found 9 models of TULA by Smith & Nephew, Inc. in the FDA's device registry (GUDID). Together they are named in 29 adverse event reports in the FDA's MAUDE database, received between Sep 10, 2021 and Oct 31, 2025 — classified as 22 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (7 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

Most reported TULA problems

TULA models

9 models, most reported first. Each model has its own page with its reports, recalls and device details.

• TULA 72290090

  Tympanostomy tube delivery product with drug
  7 reports
• TULA TDS114G

  Tympanostomy tube delivery product with drug
  5 reports
• TULA TULAKIT2

  Tympanostomy tube delivery product with drug
  4 reports
• TULA TYMB001

  Tympanostomy tube delivery product with drug
  4 reports
• TULA 72290097

  Tympanostomy tube delivery product with drug
  3 reports
• TULA IOCNTRL

  Tympanostomy tube delivery product with drug
  2 reports
• TULA 72290098

  Tympanostomy tube delivery product with drug
  2 reports
• TULA EP1P

  Tympanostomy tube delivery product with drug
  1 report
• TULA EP2B

  Tympanostomy tube delivery product with drug
  1 report

Recent TULA adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjuryOct 31, 2025Premature Activation; Premature Activation

  IT WAS REPORTED THAT, DURING A TYMPANOSTOMY, ONE (1) TULA TDS DEPLOYED THE TUBE PREMATURELY. THE PROCEDURE WAS CANCELLED AND RESCHEDULED FOR THE OR. NO FURTHER COMPLICATIONS WERE REPORTED. THE PATIENT IS FINE WITH AN OR PLACED TUBE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23442205 ↗
• MalfunctionOct 10, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT, DURING A TYMPANOSTOMY, THE IONTOPHORESIS WITH A TULA KIT WAS UNSUCCESSFUL DUE TO THE PATIENT'S TYMPANIC MEMBRANE BEING TOO THICK, AND COULD NOT BE ANESTHETIZED. THE PROCEDURE WAS NOT COMPLETED, AND THE PATIENT DID NOT RECEIVED THE TULA TUBES AT THE MOMENT; HOWEVER, IT WAS RESCHEDULED AND SUCCESSFULLY PERFORMED IN THE OR THE FOLLOWING WEEK. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23272730 ↗
• MalfunctionAug 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A TYMPANOSTOMY, THE PATIENT'S FATHER BELIEVED THE CHILD WAS HAVING AN ALLERGIC REACTION DURING IONTOPHORESIS. THE CHILD'S FOREHEAD WAS RED, AND THE PARENTS WERE CONCERNED. THE PHYSICIAN CAME IN TO ADDRESS THE SITUATION, EXAMINED THE CHILD, ASKED THE PARENTS SOME FAMILY HISTORY QUESTIONS, AND ULTIMATELY ABORTED THE PROCEDURE OUT OF AN ABUNDANCE OF CAUTION AND RESCHEDULED FOR THE OR. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 22727008 ↗
• MalfunctionMar 10, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING A TYMPANOSTOMY USING A TULA KIT, THE PATIENT WAS NO LONGER DEEMED A GOOD CANDIDATE FOR A TULA PROCEDURE DUE TO TEMPERAMENT. THE PROCEDURE WAS CANCELLED AND RESCHEDULED TO HAVE SURGERY IN THE OR. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21562503 ↗
• InjuryJan 28, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT AFTER AN UNLITERAL TYMPANOSTOMY ON (B)(6) 2024. THE PATIENT HAD A FOLLOW-UP VISIT. DURING THE POST OP EXAM, IT WAS OBSERVED THAT THE TUBE HAD MEDIALIZED, THOUGH THE EXACT TIME WAS UNCLEAR. THE PATIENT HAS BEEN SCHEDULED FOR A TUBE RETRIEVAL IN THE OR. NO FURTHER COMPLICATIONS WERE REPORTED. PATIENT CURRENT STATUS IS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21261140 ↗
• InjuryJan 23, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING A TYMPANOSTOMY USING A TULA KIT, THE PATIENT WAS NO LONGER DEEMED A GOOD CANDIDATE TO USE THE TULA SYSTEM DUE TO PATIENT TEMPERAMENT. THE PROCEDURE WAS ABORTED AND RESCHEDULED TO HAVE SURGERY IN THE OR. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Discomfort

  MAUDE report 21218426 ↗
• MalfunctionDec 16, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT DURING A TYMPANOSTOMY, FOUR (4) EARPLUGS, SIZE 2 , DID NOT STAY IN EAR CANAL. THE RIGHT SIDE STARTED WITH A SIZE 3, BUT UPON FAILURE A SIZE 2 WAS TRIED BUT SINCE IT FAILED A SIZE 3 WAS TRIED AGAIN. THE EARPAD WAS USED PROPERLY AND SEEMED TO BE WORKING UNTIL A LEAK OCCURRED LESS THAN A MINUTE INTO IONTOPHORESIS. AFTER THAT LEAK, IT WAS UNABLE TO MAINTAIN EAR PLUG STABILIZATION AND TRIED BOTH SIZES 2 AND 3 IN THE CANAL. THE CANAL WAS DRIED EACH TIME BEFORE REPLACING THE PLUG AND FILLING. THE CHILD WAS CRYING AND FIDGETING WHICH EVENTUALLY LED TO THE EARPAD FAILING. ALCOHOL WAS USED TO CLEAN THE EAR CANAL PRIOR TO THE FINAL ATTEMPT ON THE RIGHT SIDE. WITHOUT THE EARPAD IN PLACE, THE EARPLUG SIMPLY POPPED OUT. THE LEFT SIDE WAS STARTED WITH A SIZE 3 WHICH STABILIZED LONGER ON THIS SIDE AS IT ONLY HAD 2 ALARMS. AFTER THE FIRST ALARM, IT WAS REPLACED WITH A SIZE 2. THE SIZE 2 WAS TOO SMALL SO QUICKLY IT WENT BACK TO SIZE 3. THE SIZE 3 MAINTAINED STABILIZATION ON THIS SIDE WELL INTO THE 3RD PHASE OF IONTOPHORESIS AND THE CHILD MANUALLY PULLED IT OUT. UPON RECEIVING THE SECOND ALARM IN THE 3RD PHASE, THE SPECIALIST CHOSE NOT TO PROCEED AS THE RIGHT SIDE WAS NOT SEATING

  Patient problems: Discomfort

  MAUDE report 20938935 ↗
• InjuryOct 21, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT DURING A TYMPANOSTOMY, THE TULA GEN 2 ROTATING ARM WAS DEFECTIVE. THE ROTATING ARM WAS MEANT TO HOLD COUNTER PRESSURE TO HELP HOLD THE EAR PLUG IN PLACE, HOWEVER, THERE WAS SIGNIFICANT PATIENT MOVEMENT AND THE ROTATING ARM CAME LOOSE TOO EASILY AND IT ENDED UP BECOMING AN HINDRANCE. THE PATIENT GOT SWEATY WHEN GOT WORKED UP AND CRIED, THUS, THE ADHESIVE ON THE PIECE THAT ADHERES TO THE NECK OFTEN CAME OFF AND LOOSE ITS STICKINESS TO THE PATIENTS SWEATY SKIN, BECOMING INEFFECTIVE. THE PROCEDURE WAS CANCELLED AND RESCHEDULED FOR THE OPERATING ROOM. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Discomfort

  MAUDE report 20495029 ↗
• InjuryOct 15, 2024Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED THAT DURING A TYMPANOSTOMY, THE IONTOPHORESIS STARTED WITH THE TULA KIT SIZE 2 EARPLUGS THAT WERE TOO SMALL, THUS, THE EARPLUGS WERE SWAPPED TO SIZE 3. THE IONTOPHORESIS PROCEEDED FOR 3 MINUTES AND THE SPEED WAS REDUCED UPON PATIENT DISTRESS. THE PATIENT CALMED DOWN AFTERWARD AND THE IONTOPHORESIS PROCEEDED UNTIL COMPETITION WITH NO COMPLICATIONS. THE DOCTOR PROCEEDED WITH THE TUBE INSERTION AND UPON MAKING CONTACT WITH THE TYMPANIC MEMBRANE THE PATIENT SCREAMED IN PAIN. THE DOCTOR WAS UNABLE TO TRY TO DEPLOY THE TUBE AND THE PARENTS OPTED TO FINISH THE PROCEDURE IN THE OR. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Discomfort; Pain

  MAUDE report 20450971 ↗
• InjuryOct 15, 2024Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED THAT DURING A TYMPANOSTOMY, THE PATIENT'S EAR WAS THOROUGHLY CLEANED PRIOR THE IONTOPHORESIS WITH THE TULA KIT. THE IONTOPHORESIS WAS SETUP AND COMPLETED WITHOUT ANY COMPLICATIONS. AS THE DOCTOR MADE CONTACT WITH THE TYMPANIC MEMBRANE THE PATIENT SCREAMED IN PAIN AND WOULD NOT LET THE DOCTOR HAVE A SECOND TRY, THEREFORE, THE PARENTS OPTED TO FINISH THE PROCEDURE IN THE OR. THE PARENT MADE A COMMENT AFTERWARD ASKING IF IT WAS LIDOCAINE THAT WAS USED TO NUMB THE AREA BECAUSE THE PATIENT WAS MOSTLY NON-RESPONSIVE TO LIDOCAINE AND RECENTLY HAD A PROCEDURE WITH LIDOCAINE INJECTIONS AND THE LIDOCAINE INJECTIONS WERE LARGELY INEFFECTIVE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Discomfort; Pain

  MAUDE report 20450911 ↗
• InjuryOct 15, 2024Premature Activation; Therapeutic or Diagnostic Output Failure; Premature Activation; Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED THAT DURING A TYMPANOSTOMY, THE PATIENT'S EAR WAS THOROUGHLY CLEANED PRIOR THE IONTOPHORESIS WITH THE TULA KIT. THE IONTOPHORESIS WAS STARTED AND COMPLETED WITHOUT COMPLICATIONS. AS THE DOCTOR MADE CONTACT WITH EAR DRUM THE PATIENT SCREAMED IN PAIN. THE DOCTOR ATTEMPTED TO DEPLOY THE TUBE QUICKLY AND MADE A MYRINGOTOMY BUT THE TUBE DID NOT PENETRATE THE TYMPANIC MEMBRANE. THE TUBE WAS RETRIEVED. THE PATIENT CALMED DOWN ENOUGH TO ALLOW THE DOCTOR TO TRY AGAIN BUT AS SOON AS HE MADE CONTACT WITH THE TYMPANIC MEMBRANE AGAIN THE PATIENT SCREAMED AND WOULD NOT ALLOW FOR TUBE DEPLOYMENT. THEREFORE, THE PARENT'S OPTED TO FINISH THE PROCEDURE IN THE OR. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Discomfort; Pain

  MAUDE report 20450846 ↗
• MalfunctionSep 26, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A TYMPANOSTOMY, WHILE TUBE PLACEMENT; THE SURGEON REPORTED A TUBE MEDIALIZATION WITH THE SECOND TDS DEVICE. THE SURGEON REPORTED HE WAS ABLE TO SUCCESSFULLY PLACE A BACK UP DEVICE IN THE TYMPANIC MEMBRANE. THERE WAS A DELAY LESS THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20307244 ↗
• InjurySep 25, 2024Premature Activation; Unexpected Shutdown; Premature Activation; Unexpected Shutdown

  IT WAS REPORTED THAT DURING A TYMPANOSTOMY, DURING THE IONTOPHORESIS, THE SURGEON DOUBLE CLICKED ON BOTH CHANNEL BUTTONS TO ENTER "REDUCE MODE" AND THE FAULT INDICATOR LIT UP AND THE CONTROL UNIT STOPPED WORKING. THE SURGEON INSISTED TO USE ANOTHER CONTROL UNIT AND UTILIZED A SPARE TO COMPLETE THE IONTOPHORESIS. AFTER IT WAS COMPLETED, THE SURGEON DEPLOYED THE TUBE DELIVERY SYSTEM IN WHICH A "SHORT SHOT" OCCURRED. THE SURGEON PROMPTLY REMOVED THE TUBE FROM THE EAR CANAL, AND UTILIZED A REPLACEMENT TDS DEVICE. THEY TRIED TO MOVE ON TO THE NEXT EAR AND DUE TO THE PATIENT´S TEMPERAMENT, THE PROCEDURE WAS ABORTED AND RE-SCHEDULED IN THE OPERATING ROOM. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Unspecified Mental, Emotional or Behavioral Problem

  MAUDE report 20301458 ↗
• InjurySep 25, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING A TYMPANOSTOMY, WHEN THE TULA KIT BILATERAL WAS OPENED, THE SURGEON MADE THE CLINICAL DETERMINATION THAT THE PATIENT WAS NOT A GOOD FIT FOR THE PROCEDURE DUE TO PATIENT TEMPERAMENT, THUS, THE PROCEDURE WAS ABORTED AND RE-SCHEDULE FOR THE OR. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Unspecified Mental, Emotional or Behavioral Problem

  MAUDE report 20301406 ↗
• InjuryAug 20, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING A TYMPANOSTOMY WHILE USING THE TULA KIT, THE SPECIALIST NO LONGER DEEMED THE PATIENT A GOOD CANDIDATE TO USE THE TULA SYSTEM DUE TO PATIENT TEMPERAMENT. THE PROCEDURE WAS CANCELLED AND RESCHEDULED TO SURGERY IN THE OPERATING ROOM. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Emotional Changes

  MAUDE report 20009015 ↗

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