TR BAND TRB24-REG (UDI 00389701011349)Recalls & reported problems

Summary

The FDA's MAUDE database contains 284 adverse event reports that list this exact device (DI 00389701011349), received between Apr 25, 2017 and May 11, 2026 — classified as 86 injuries, 198 malfunctions.

The most frequently reported specific device problem is “Gas/Air Leak” (134 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 25 most recent of 284 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 11, 2026Gas/Air Leak; Unintended Deflation

  TERUMO RECEIVED THE FOLLOWING REPORTED INFORMATION: THE TR BAND WAS APPLIED PER PROTOCOL FOLLOWING A CORONARY ANGIOGRAM; HOWEVER, LESS THAN ONE MINUTE LATER, THE BAND DID NOT HOLD AIR/DEFLATED. THE BAND WAS REMOVED AND A NEW BAND WAS PLACED WITHOUT INCIDENT. THE PROCEDURE WAS INVASIVE, AND THERE WAS UNEXPECTED OR PROLONGED CARE. A 6 FRENCH RADIAL SHEATH WAS USED AT THE ACCESS SITE DURING THE PROCEDURE. THERE WAS NO HARM TO THE PATIENT. THERE WAS NO NOTICEABLE DAMAGE TO THE DEVICE. NO BLOOD WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25137491 ↗
• MalfunctionMay 5, 2026Gas/Air Leak; Unintended Deflation

  TERUMO RECEIVED THE FOLLOWING REPORTED INFORMATION: FOLLOWING A LEFT HEART CATHETERIZATION (LHC), THE BAND WAS APPLIED AND 12ML AIR WAS INJECTED INTO THE TR BAND. IMMEDIATELY AFTER THE PROCEDURE, THE LARGE AND SMALL BALLOON ASSEMBLY BEGAN TO LOSE AIR AND DEFLATED, RESULTING IN A NEW BAND BEING PLACED. HEMOSTASIS WAS ACHIEVED, THE PATIENT WAS STABLE, AND NO BLOOD LOSS WAS REPORTED. THERE WAS NO NOTICEABLE DAMAGE TO THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25083104 ↗
• MalfunctionApr 23, 2026Deflation Problem; Gas/Air Leak

  TERUMO MEDICAL CORPORATION RECEIVED THE FOLLOWING INFORMATION: IT WAS REPORTED THAT AFTER RECEIVING A RADIAL ACCESS HEART CATHETERIZATION THE FEMALE PATIENT HAD A TR BAND PLACED ON THE WRIST. AS THE PATIENT WAS BEING TRANSPORTED FROM THE ROOM STAFF NOTICED THAT THERE WAS BLOOD AROUND THE ACCESS SITE, THE BALLOON DEFLATED BEFORE PATIENT LEFT THE LAB. THE TR BAND HAD LOST AIR. THE DOCTOR REMOVED THE TR BAND AND HELD PRESSURE UNTIL A NEW BAND WAS PLACED ON THE WRIST. THERE WERE NO ISSUES WITH THE NEW BAND. THERE WAS NO RECORDED BLOOD LOSS NOR REPORTED FURTHER PATIENT INJURY. THE NURSE STATED THAT THEY TESTED THE TR BAND AFTER REMOVAL AND FOUND THAT IT WAS LEAKING AIR. THE LEAK WAS COMING FROM THE BALLOON. THE PATIENT WAS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24975304 ↗
• MalfunctionApr 17, 2026Deflation Problem; Gas/Air Leak

  TERUMO MEDICAL CORPORATION RECEIVED THE FOLLOWING INFORMATION: IT WAS REPORTED THAT ORIGINAL A TR BAND WAS APPLIED POST RADIAL PROCEDURE. A HEMATOMA DEVELOPED PROXIMAL TO THE BAND AFTER A COUPLE OF MINUTES. MANUAL PRESSURE WAS APPLIED AND THEN THE TR BAND WAS REPOSITIONED. IT WAS NOTED AT THAT POINT THAT THE TR BAND APPEARED TO BE LOSING AIR. MORE AIR WAS ADDED, HOWEVER, AGAIN THERE WAS A SLOW LEAK. A NEW TR BAND WAS PLACED ON THE PATIENT AND THERE WERE NO FURTHER COMPLICATIONS. HEMOSTASIS WAS ACHIEVED USING THE SECOND TR BAND THAT WAS APPLIED. THE FIRST TR BAND INITIALLY HAD 15ML OF AIR, HOWEVER, DURING REPOSITIONING, IT WAS NOTICED THAT ONLY 12ML WAS ABLE TO BE REMOVED. 15ML WAS ADDED FOR THE REPOSITIONING AND THEN WHEN AIR WAS LEAKING AGAIN, A NEW TR BAND WAS APPLIED WITH 11ML OF FINAL AIR VOLUME (WHICH HELD JUST FINE). THE TR BAND STARTED TO DEFLATE WITHIN A FEW MINUTES, ONCE IT WAS DETERMINED THAT THEY WANTED TO REPOSITION THE BAND. THEY SUSPECTED THE LEAK WAS COMING FROM THE "PILLOW" HOWEVER, THEY WERE UNABLE TO CONFIRM EXACTLY WHERE. THE SIZE OF THE HEMATOMA WAS ABOUT THE SIZE OF A HALF DOLLAR COIN. THE PATIENT REMAINED IN STABLE CONDITION. THE SECOND TR BAND THAT WAS APPLIE

  Patient problems: Hematoma

  MAUDE report 24917532 ↗
• MalfunctionApr 13, 2026Gas/Air Leak; Unintended Deflation

  TERUMO MEDICAL CORPORATION RECEIVED THE FOLLOWING INFORMATION: IT WAS REPORTED THAT THE TR BAND DID NOT HOLD AIR, THEY FINISHED WITH A NEW TR BAND. APPROXIMATELY 15ML OF AIR WAS INJECTED WHEN THE TR BAND WAS APPLIED, HOWEVER IT WOULD NOT MAINTAIN AIR AT THE BEGINNING OF THE PROCEDURE. A GLIDESLENDER SHEATH WAS USED AT THE ACCESS SITE. THE ESTIMATED BLOOD LOSS WAS LESS THAN 250CC. THE PATIENT REMAINED STABLE AND THERE WAS NO PATIENT HARM. THE PROCEDURE PERFORMED PRIOR TO THE USE OF THE TR BAND WAS A PERCUTANEOUS CORONARY INTERVENTION (PCI). THERE WAS NOT ANY NOTICEABLE DAMAGE TO THE DEVICE. IT IS UNKNOWN HOW HEMOSTASIS WAS ACHIEVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24865738 ↗
• MalfunctionApr 11, 2026Gas/Air Leak; Unintended Deflation

  TERUMO MEDICAL CORPORATION RECEIVED THE FOLLOWING INFORMATION: IT WAS REPORTED THAT THE TR BAND WOULD NOT HOLD AIR PRESSURE. THERE WAS 18ML OF AIR INJECTED INTO THE TR BAND WHEN IT WAS APPLIED. THE TR BAND STARTED TO DEFLATE AFTER INITIAL INFLATION. THERE WAS NO NOTICEABLE DAMAGE TO THE DEVICE. THE LOCATION OF THE LEAK IS UNKNOWN. THE PATIENT REMAINED IN STABLE CONDITION AND THERE WAS NO PATIENT HARM. HEMOSTASIS WAS ACHIEVED BY A SECOND TR BAND. THE PROCEDURE PERFORMED PRIOR TO THE USE OF THE TR BAND WAS LEFT HEART CATHETERIZATION. THE ESTIMATED BLOOD LOSS WAS LESS THAN 250CC.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24850671 ↗
• MalfunctionApr 8, 2026Deflation Problem; Gas/Air Leak

  TERUMO MEDICAL CORPORATION RECEIVED THE FOLLOWING REPORTED INFORMATION: FOLLOWING A CARDIAC CATH, THE TR BAND WAS PLACED AND 15ML'S OF AIR WAS INJECTED INTO THE BAND. THEN 5 WAS THEN REPLACED. TWO MINUTES, THE TR BAND STARTED TO DEFLATE/LOST PRESSURE IN THE BALLOON AREA. THERE WAS NO NOTICEABLE DAMAGE TO THE DEVICE. THE BLOOD LOSS WAS LESS THAN 250CC, AND THE PATIENT WAS STABLE. THE PATIENT DID BLEED AND DEVELOPED A HEMATOMA; HOWEVER, WAS STABLE AND OKAY AFTERWARDS. THE SIZE OF THE HEMATOMA WAS UNKNOWN. A SECOND TR BAND WAS PLACED ON TO PROVIDE PRESSURE TO THE HEMATOMA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24816277 ↗
• MalfunctionApr 2, 2026Gas/Air Leak; Unintended Deflation

  TERUMO MEDICAL CORPORATION RECEIVED THE FOLLOWING INFORMATION: IT WAS REPORTED THAT UPON PLACING THE TR BAND AND FILLING WITH AIR, IT IMMEDIATELY BEGAN TO SELF-DEFLATE. A NEW TR BAND WAS PLACED. THERE WAS NO PATIENT INJURY REPORTED AND NO BLOOD LOSS. THE PROCEDURE PERFORMED PRIOR TO THE USE OF THE TR BAND WAS LEFT HEART CATHETERIZATION (LHC).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24772670 ↗
• MalfunctionApr 2, 2026Gas/Air Leak; Unintended Deflation

  TERUMO MEDICAL CORPORATION RECEIVED THE FOLLOWING INFORMATION: IT WAS REPORTED THAT WHEN PUTTING AIR INTO THE TR BAND, IT WAS NOT HOLDING AIR AND SLOWLY DEFLATED. A NEW TR BAND WAS PLACED AND HEMOSTASIS WAS ACHIEVED. THE PATIENT REMAINED IN STABLE CONDITION. THERE WAS THE NORMAL AMOUNT OF AIR INJECTED UNTIL BLEEDING STOPPED. THERE WAS NO VISIBLE DAMAGE NOTED ON THE TR BAND. THE PROCEDURE PERFORMED FOR THE PATIENT WAS A PERCUTANEOUS CORONARY INTERVENTION (PCI). THE ESTIMATED BLOOD LOSS WAS LESS THAN 250CC.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24772667 ↗
• MalfunctionApr 2, 2026Gas/Air Leak; Unintended Deflation

  TERUMO MEDICAL CORPORATION RECEIVED THE FOLLOWING REPORTED INFORMATION: FOLLOWING A RIGHT HEART CATH, THE TR BAND WAS APPLIED AND 13ML'S (11CC) OF AIR WAS INJECTED INTO THE BAND. FORTY-FIVE (45) MINUTES LATER, THE PATIENT WAS MOVED FROM THE OPERATING ROOM (OR) TO THE HOLDING AREA. WHEN THE NURSE CHECKED THE TR BAND, THEY NOTICED THE AIR WAS DISSOLVED. A SLOW LEAK OVER TIME OCCURRED. THE BALLOON WITH 5CC OF AIR LEAKED OVER A TWO (2) HOUR PERIOD. THERE WAS NO NOTICEABLE DAMAGE TO THE DEVICE. THE DEVICE WAS REMOVED AND REPLACED WITH NEW TR BAND AND HEMOSTASIS WAS ACHIEVED. THERE WAS MINIMAL BLOOD LOSS, LESS THAN 5CC, AND THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24766348 ↗
• MalfunctionMar 31, 2026Gas/Air Leak

  TERUMO MEDICAL CORPORATION RECEIVED THE FOLLOWING REPORTED INFORMATION: FOLLOWING A LEFT HEART CATH, THE BALLOON OF THE TR BAND LOST AIR IMMEDIATELY AFTER PLACEMENT, SLOW LEAK AT 5CC/HR. THERE WAS NO NOTICEABLE DAMAGE TO THE DEVICE. HEMOSTASIS WAS ACHIEVED BY USING A SECOND TR BAND, AND THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24743505 ↗
• MalfunctionMar 31, 2026Gas/Air Leak; Unintended Deflation

  TERUMO MEDICAL CORPORATION RECEIVED THE FOLLOWING INFORMATION: IT WAS REPORTED THAT THE TR BAND WAS APPLIED. IT WAS NOTICED AFTER BALLOON INFLATION THAT THE BALLOONS DEFLATED IMMEDIATELY AFTER REMOVING THE SYRINGE AND BLEEDING WAS NOTICED. MULTIPLE ATTEMPTS TO INFLATE THE TR BAND DID NOT WORK. THE TR BAND WAS REPLACED WITH NEW TR BAND AND RECOVERY PROCEEDED WITHOUT ISSUE. THERE WAS NO NOTICEABLE DAMAGE. THE PATIENT REMAINED IN STABLE CONDITION, WITH MINIMAL BLEEDING AND NO HEMATOMA. THE LOCATION OF THE LEAK AND AMOUNT OF AIR THAT WAS INITIALLY APPLIED ARE BOTH UNKNOWN. THE PROCEDURE PERFORMED PRIOR TO THE USE OF THE TR BAND WAS CARDIAC CATHETERIZATION AND PERCUTANEOUS CORONARY INTERVENTION (PCI).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24741703 ↗
• MalfunctionMar 30, 2026Unintended Deflation

  TERUMO MEDICAL CORPORATION RECEIVED THE FOLLOWING REPORTED INFORMATION: FOLLOWING A LEFT HEART CATH, THE TR BAND WAS APPLIED. HOWEVER, A DEFLATION ISSUE WITH THE BALLOON OCCURRED AND LED TO A HEMATOMA. THE ESTIMATED BLOOD LOSS WAS LESS THAN 250CC.

  Patient problems: Hematoma

  MAUDE report 24731576 ↗
• MalfunctionMar 30, 2026Unintended Deflation

  TERUMO MEDICAL CORPORATION RECEIVED THE FOLLOWING REPORTED INFORMATION: FOLLOWING A LEFT HEART CATH, THE TR BAND WAS APPLIED. HOWEVER, A DEFLATION ISSUE WITH THE BALLOON OCCURRED AND LED TO A HEMATOMA. THE ESTIMATED BLOOD LOSS WAS LESS THAN 250CC.

  Patient problems: Hematoma

  MAUDE report 24730491 ↗
• MalfunctionMar 30, 2026Unintended Deflation

  TERUMO MEDICAL CORPORATION RECEIVED THE FOLLOWING REPORTED INFORMATION: FOLLOWING A LEFT HEART CATH, THE TR BAND WAS APPLIED. HOWEVER, A DEFLATION ISSUE WITH THE BALLOON OCCURRED AND LED TO A HEMATOMA. THE ESTIMATED BLOOD LOSS WAS LESS THAN 250CC.

  Patient problems: Hematoma

  MAUDE report 24730408 ↗
• MalfunctionMar 30, 2026Unintended Deflation

  TERUMO MEDICAL CORPORATION RECEIVED THE FOLLOWING REPORTED INFORMATION: FOLLOWING A LEFT HEART CATH, THE TR BAND WAS APPLIED. HOWEVER, A DEFLATION ISSUE WITH THE BALLOON OCCURRED AND LED TO A HEMATOMA. THE ESTIMATED BLOOD LOSS WAS LESS THAN 250CC.

  Patient problems: Hematoma

  MAUDE report 24730357 ↗
• MalfunctionMar 30, 2026Gas/Air Leak

  TERUMO MEDICAL RECEIVED AN FDA MEDWATCH REPORT # (B)(4). THE EVENT DESCRIPTION STATES: "APPLYING TR BAND ON A PATIENT POST CARDIAC CATH, THE PHYSICIAN ATTEMPTED TO INFLATE THE DEVICE AND IT FAILED TO HOLD THE AIR. DEVICE REMOVED FROM PATIENT AND ANOTHER ONE WAS APPLIED." ADDITIONAL INFORMATION WAS RECEIVED ON 11MAR2026: THE TR BAND WAS REMOVED FROM THE PATIENT AND ANOTHER ONE WAS APPLIED. THE SHEATH REMAINED IN PLACE UNTIL ANOTHER TR BAND WAS APPLIED SUCCESSFULLY. THE FAILURE WAS SEEN IN THE CATH LAB AND WAS NOTED DURING INFLATION. THE DEVICE WAS NOT MANIPULATED BEFORE USE IN ANY WAY, PRE-USE OR DURING STORAGE. THE PRODUCT WAS STORED PRIOR TO USE IN THE CABINET. THE PATIENT REMAINED IN STABLE CONDITION AND THERE WAS NO PATIENT HARM. THERE WAS NO BLOOD LOSS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24725531 ↗
• MalfunctionMar 24, 2026Gas/Air Leak; Unintended Deflation

  TERUMO MEDICAL CORPORATION RECEIVED THE FOLLOWING REPORTED INFORMATION: THE NURSE TESTED THE BAND BY PUTTING 15ML OF AIR ON IT AND PRESSING ON THE BALLOON, DEFLATED THE BAND, AND THEN APPLIED TO THE PATIENT. UPON INFLATION AND APPLICATION OF BAND, THE BAND DID NOT MAINTAIN AIR AND THE PATIENT BEGAN TO BLEED. THE BAND WAS TAKEN OFF THE PATIENT AND OPENED A NEW TR BAND WAS USED WITHOUT ISSUE. THE BLOOD LOSS WAS LESS THAN 250CC.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24675350 ↗
• MalfunctionMar 19, 2026Gas/Air Leak; Unintended Deflation

  TERUMO MEDICAL CORPORATION RECEIVED THE FOLLOWING REPORTED INFORMATION: FOLLOWING A LEFT HEART CATHETERIZATION WHILE THE PATIENT WAS IN THE ROOM, THE BLADDER OF THE TR BAND DID NOT HOLD/LOST AIR. THE BLADDER WAS NOTED TO BE FLATTER UPON REMOVAL. A TERUMO 5/6 FRENCH SLENDER SHEATH WAS USED IN THE ACCESS SITE DURING THE PROCEDURE. THE TR BAND STARTED TO LOSE AIR APPROXIMATELY 5 MINUTES AFTER INITIAL INFLATION. 15 MLS OF AIR WAS INITIALLY INJECTED INTO THE TR BAND. MANUAL PRESSURE WAS HELD UNTIL A SECOND BAND WAS APPLIED; HOWEVER, THERE WAS ACTIVE BLEEDING WHEN APPLYING THE NEW BAND. HEMOSTASIS WAS ACHIEVED. THE ESTIMATED BLOOD LOSS WAS ABOUT 5CC. THE PATIENT WAS IN STABLE CONDITION AND RELEASED AS PLANNED. NO SWELLING, PAIN, NUMBNESS, FAINT PULSE, OR WEAKNESS WAS NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24642867 ↗
• MalfunctionMar 19, 2026Gas/Air Leak; Unintended Deflation

  TERUMO MEDICAL CORPORATION RECEIVED THE FOLLOWING REPORTED INFORMATION: FOLLOWING A LEFT HEART CATHETERIZATION WHILE THE PATIENT WAS IN THE ROOM, THE BLADDER OF THE TR BAND DID NOT HOLD/LOST AIR. THE BLADDER WAS NOTED TO BE FLATTER UPON REMOVAL. A TERUMO 5/6 FRENCH SLENDER SHEATH WAS USED IN THE ACCESS SITE DURING THE PROCEDURE. THE TR BAND STARTED TO LOSE AIR APPROXIMATELY 5-10 MINUTES AFTER INITIAL INFLATION. IT WAS UNKNOWN HOW MANY ML'S WERE INITIALLY INJECTED. MANUAL PRESSURE WAS HELD UNTIL A SECOND BAND WAS APPLIED; HOWEVER, THERE WAS ACTIVE BLEEDING WHEN APPLYING THE NEW BAND. HEMOSTASIS WAS ACHIEVED. THE ESTIMATED BLOOD LOSS WAS ABOUT 5-10CC. THE PATIENT WAS IN STABLE CONDITION AND RELEASED AS PLANNED. NO SWELLING, PAIN, NUMBNESS, FAINT PULSE, OR WEAKNESS WAS NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24642866 ↗
• MalfunctionMar 19, 2026Gas/Air Leak; Unintended Deflation

  TERUMO MEDICAL CORPORATION RECEIVED THE FOLLOWING REPORTED INFORMATION: FOLLOWING A LEFT HEART CATHETERIZATION WHILE THE PATIENT WAS IN THE ROOM, THE BLADDER OF THE TR BAND DID NOT HOLD/LOST AIR. THE BLADDER WAS NOTED TO BE FLATTER UPON REMOVAL. A TERUMO 5/6 FRENCH SLENDER SHEATH WAS USED IN THE ACCESS SITE DURING THE PROCEDURE. THE TR BAND STARTED TO LOSE AIR APPROXIMATELY 5 MINUTES AFTER INITIAL INFLATION. 15 MLS OF AIR WAS INITIALLY INJECTED INTO THE TR BAND. MANUAL PRESSURE WAS HELD UNTIL A SECOND BAND WAS APPLIED; HOWEVER, THERE WAS ACTIVE BLEEDING WHEN APPLYING THE NEW BAND. HEMOSTASIS WAS ACHIEVED. THE ESTIMATED BLOOD LOSS WAS ABOUT 5CC. THE PATIENT WAS IN STABLE CONDITION AND RELEASED AS PLANNED. NO SWELLING, PAIN, NUMBNESS, FAINT PULSE, OR WEAKNESS WAS NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24642865 ↗
• MalfunctionMar 19, 2026Gas/Air Leak; Unintended Deflation

  TERUMO MEDICAL CORPORATION RECEIVED THE FOLLOWING REPORTED INFORMATION: FOLLOWING A LEFT HEART CATHETERIZATION WHILE THE PATIENT WAS IN THE ROOM, THE BLADDER OF THE TR BAND DID NOT HOLD/LOST AIR. THE BLADDER WAS NOTED TO BE FLATTER UPON REMOVAL. A TERUMO 5/6 FRENCH SLENDER SHEATH WAS USED IN THE ACCESS SITE DURING THE PROCEDURE. THE TR BAND STARTED TO LOSE AIR APPROXIMATELY 5 MINUTES AFTER INITIAL INFLATION. 15 MLS OF AIR WAS INITIALLY INJECTED INTO THE TR BAND. MANUAL PRESSURE WAS HELD UNTIL A SECOND BAND WAS APPLIED; HOWEVER, THERE WAS ACTIVE BLEEDING WHEN APPLYING THE NEW BAND. HEMOSTASIS WAS ACHIEVED. THE ESTIMATED BLOOD LOSS WAS ABOUT 5CC. THE PATIENT WAS IN STABLE CONDITION AND RELEASED AS PLANNED. NO SWELLING, PAIN, NUMBNESS, FAINT PULSE, OR WEAKNESS WAS NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24642864 ↗
• MalfunctionMar 2, 2026

  APPLYING TR BAND ON A PATIENT POST CARDIAC CATH, THE PHYSICIAN ATTEMPTED TO INFLATE THE DEVICE AND IT FAILED TO HOLD THE AIR. DEVICE REMOVED FROM PATIENT AND ANOTHER ONE WAS APPLIED. MANUFACTURER RESPONSE FOR CLAMP, VASCULAR, TR BAND (PER SITE REPORTER). CLINICAL REPRESENTATIVE FROM TERUMO WILL BE INTO EVALUATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24477533 ↗
• MalfunctionJan 29, 2026Deflation Problem

  TERUMO MEDICAL CORPORATION RECEIVED THE FOLLOWING REPORTED INFORMATION: PERCUTANEOUS CORONARY INTERVENTION VIA RADIAL ACCESS USING A 6 FRENCH GLIDESHEATH SLENDER SHEATH. THE PATIENT BEGAN TO DEVELOP HEMATOMA FOLLOWING CONCLUSION OF PROCEDURE AND PLACEMENT OF THE TR BAND. THE TR BAND WAS PLACED PER PROTOCOL AND INSTRUCTION FOR USE (IFU). THE BALLOON DEFLATED PREMATURELY AND BLOOD APPEARED. THE TR BAND WAS RE-INFLATED FOR HEMOSTASIS. THE PATIENT SHOWED HEMATOMA SYMPTOMS UPON REACHING POST-PROCEDURAL ROOM & CARE. PROCEDURE WAS DEEMED SUCCESSFUL. THERE WAS NO BLOOD LOSS.

  Patient problems: Hematoma

  MAUDE report 24217879 ↗
• MalfunctionJan 15, 2026Gas/Air Leak

  TERUMO MEDICAL CORPORATION RECEIVED THE FOLLOWING REPORTED INFORMATION: TR BAND WAS APPLIED BY THE DOCTOR AND AN EXPERIENCED TECH. IT SEEMED OK AT FIRST, HOWEVER, THEN THEY NOTICED A HEMATOMA AND THAT THE TR BAND HAD DEFLATED. MANUAL PRESSURE AND NEW TR BAND WAS APPLIED. ADDITIONAL INFORMATION WAS RECEIVED ON 23DEC2025: THERE WAS 15ML OF AIR INJECTED INTO THE TR BAND WHEN IT WAS APPLIED. A 5FR SLENDER WAS USED IN THE ACCESS SITE DURING THE PATIENT PROCEDURE. THE TR BAND DEFLATED INSTANTLY, IT HAD A HOLE IN IT. THE HEMATOMA WAS TREATED BY MANUAL PRESSURE. THE SIZE OF THE HEMATOMA WAS TWO INCHES. THERE WAS SWELLING INITIALLY. THERE WAS NO PAIN OR NUMBNESS. THE PULSE WAS NOT FAINT AND NO WEAKNESS IN MOVEMENT. THERE WAS NO NOTICEABLE DAMAGE TO THE DEVICE. THE PATIENT WAS STABLE.

  Patient problems: Hematoma; Swelling/ Edema

  MAUDE report 24090315 ↗