TR BAND TRB29-LRG (UDI 00389701012476)Recalls & reported problems
Terumo Medical Corporation · TR BAND Radial Artery Compression Device · Class 2
All models of TR BAND (4)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
The TR Band is a wrist compression device Terumo uses to hold down the puncture site after a catheterization. Reports mostly describe the band losing air or deflating on its own soon after inflation, sometimes letting blood leak from the access site. There are 62 reports, no deaths and 6 injuries, with 17 in the last 12 months compared with 5 before that. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 65
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 65 adverse event reports that list this exact device (DI 00389701012476), received between May 24, 2023 and Sep 23, 2026 — classified as 6 injuries, 59 malfunctions.
The most frequently reported specific device problem is “Gas/Air Leak” (49 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.
Reports received per month
Most reported problems
Device problems
- Gas/Air Leak49
- Deflation Problem23
- Unintended Deflation15
- Air/Gas in Device1
Patient problems
- No Clinical Signs, Symptoms or Conditions59
- Hemorrhage/Blood Loss/Bleeding2
- Insufficient Information2
- Hematoma1
- Pain1
- Swelling/ Edema1
Recent adverse event reports
The 25 most recent of 65 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 23, 2026Unintended Deflation
Terumo received the following reported information: After the TR Band was placed and the patient was transferred to the recovery area, it was observed that the band had completely deflated. The device was reinflated; however, it immediately deflated again, indicating that it was unable to maintain inflation and adequate compression. The situation was identified and managed immediately. The defective device was removed and replaced with another TR Band with other lot, which functioned appropriately. The patient experienced no significant blood loss or additional complications related to the event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50869026 ↗MalfunctionSep 21, 2026Gas/Air Leak
Terumo Medical received a MedWatch report (b)(4). The MedWatch event description stated that: ¿TR Band was placed on patient post heart cath. Patient returned to prep/recovery from cath lab with 15cc of air in patients band. Every 15 minute checks were completed on patient. Air was to be removed from TR band two hours post cath. When nurse attempted to start removing air, only 1cc of air was in the band. 14cc of air had leaked out very slowly over a two hour period. No hematoma, or bleeding from site.¿
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50841506 ↗MalfunctionSep 8, 2026Gas/Air Leak; Unintended Deflation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50679488 ↗MalfunctionSep 1, 2026Gas/Air Leak; Unintended Deflation
Terumo received the following reported information: Following a Heart Cath, the band was placed as normal, 12mL of air was injected into the band, and the patient was taken to post op. The nurse checked the band sixty (60) minutes after, and it was completely deflated. They proceeded to add 6ml in which the band deflated after a few minutes to one (1) ml. The location of the air leak was unknown. A new band was placed and had no issues. The patient had no blood loss or post op issues. It was also unknown whether there was any noticeable damage to the device or whether the device had been manipulated in any way before use or during storage. Prior to use, the product was stored under standard storage conditions.MedSun(b)(4): Unplanned air loss in Radial Artery Compression Device (TR Band-TERUMO) after Cath Procedure (Supply defective- TR Band would not hold air)
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50546880 ↗MalfunctionAug 6, 2026Unintended Deflation; Air/Gas in Device
Patient problems: Swelling/ Edema
MAUDE report 50150841 ↗MalfunctionAug 5, 2026Gas/Air Leak; Unintended Deflation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50136824 ↗MalfunctionMay 6, 2026Unintended Deflation
TERUMO RECEIVED THE FOLLOWING REPORTED INFORMATION: FOLLOWING A DIAGNOSTIC HEART CATH, 11 ML OF AIR WAS PUT INTO THE BAND, AND IT WAS PLACED WITHOUT ISSUE IN THE ROOM. WHEN NURSE WENT TO REMOVE AIR THE FIRST TIME IT WAS COMPLETELY DEFLATED. BLOOD LOSS WAS LESS THAN 250CC.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25094075 ↗MalfunctionMay 4, 2026Gas/Air Leak; Unintended Deflation
TERUMO RECEIVED THE FOLLOWING REPORTED INFORMATION: AFTER A LEFT HEART CATH, A LARGE TR BAND WAS PLACED ON THE WRIST AS PER PROTOCOL. THE AIR IMMEDIATELY DEFLATED AND THE PATIENT BLED FROM THE ACCESS SITE. NURSE APPLIED MANUAL PRESSURE AND A NEW REGULAR SIZE TR BAND WAS APPLIED. BALLOON WAS INFLATED AND BAND WAS REMOVED AS PER PROTOCOL WITH NO FURTHER INCIDENT. PROCEDURE WAS A SUCCESS AND THE PATIENT WAS STABLE. THE ESTIMATED BLOOD LOSS WAS LESS THAN 250CC. THE DEVICE WAS NOT MANIPULATED BEFORE USE IN ANY WAY - PRE-USE OR DURING STORAGE. THE PRODUCT WAS STORED PRIOR TO USE, NORMALLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25071022 ↗MalfunctionApr 29, 2026Gas/Air Leak; Unintended Deflation
TERUMO MEDICAL CORPORATION RECEIVED THE FOLLOWING INFORMATION: IT WAS REPORTED THAT THE TR BAND SEEMED TO LEAK AIR ONCE INFLATED. 13CC OF AIR WAS APPLIED TO THE TR BAND AND APPEARED TO LOSE AIR IMMEDIATELY. A SECOND TR BAND WAS PLACED ABOVE THE INITIAL TR BAND TO ACHIEVE HEMOSTASIS. PATIENT WAS IN STABLE CONDITION. IT WAS UNKNOWN WHERE THE TR BAND WAS LEAKING AIR FROM. THERE WAS NO NOTICEABLE DAMAGE TO THE DEVICE. THE DEVICE WAS NOT MANIPULATED BEFORE USE IN ANY WAY. THE TR BAND WAS STORED IN A BIN IN THE PROCEDURE ROOM. PROCEDURE PERFORMED PRIOR TO USE WITH THE TR BAND WAS LEFT HEART CATHETERIZATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25029940 ↗MalfunctionApr 29, 2026Gas/Air Leak; Unintended Deflation
TERUMO MEDICAL CORPORATION RECEIVED THE FOLLOWING INFORMATION: IT WAS REPORTED THAT THE TR BAND SEEMED TO LEAK AIR ONCE INFLATED. 13CC OF AIR WAS APPLIED TO THE TR BAND AND TOOK APPROXIMATELY 15 MINUTES TO LOSE AIR. A SECOND TR BAND WAS PLACED ABOVE THE INITIAL TR BAND TO ACHIEVE HEMOSTASIS. PATIENT WAS IN STABLE CONDITION. IT WAS UNKNOWN WHERE THE TR BAND WAS LEAKING AIR FROM. THERE WAS NO NOTICEABLE DAMAGE TO THE DEVICE. THE DEVICE WAS NOT MANIPULATED BEFORE USE IN ANY WAY. THE TR BAND WAS STORED IN A BIN IN THE PROCEDURE ROOM. PROCEDURE PERFORMED PRIOR TO USE WITH THE TR BAND WAS LEFT HEART CATHETERIZATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25024726 ↗MalfunctionApr 28, 2026Gas/Air Leak; Unintended Deflation
TERUMO MEDICAL CORPORATION RECEIVED THE FOLLOWING INFORMATION: IT WAS REPORTED THAT THE TR BAND SEEMED TO LEAK AIR ONCE INFLATED. 13CC OF AIR WAS APPLIED TO THE TR BAND AND TOOK APPROXIMATELY 15 MINUTES TO LOSE AIR. A SECOND TR BAND WAS PLACED ABOVE THE INITIAL TR BAND TO ACHIEVE HEMOSTASIS. PATIENT WAS IN STABLE CONDITION. IT WAS UNKNOWN WHERE THE TR BAND WAS LEAKING AIR FROM. THERE WAS NO NOTICEABLE DAMAGE TO THE DEVICE. THE DEVICE WAS NOT MANIPULATED BEFORE USE IN ANY WAY. THE TR BAND WAS STORED IN A BIN IN THE PROCEDURE ROOM. PROCEDURE PERFORMED PRIOR TO USE WITH THE TR BAND WAS LEFT HEART CATHETERIZATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25024112 ↗MalfunctionApr 28, 2026Unintended Deflation
TERUMO MEDICAL CORPORATION RECEIVED THE FOLLOWING REPORTED INFORMATION: UPON COMPLETION OF THE LEFT HEART CATH, THE TECHNICIAN APPLIED THE TR BAND AND INFLATED IT TO 18ML'S. THE TR BAND DEFLATED IMMEDIATELY AFTER INFLATION. THEY WERE UNABLE TO IDENTIFY WHERE THE AIR WAS LEAKING FROM. THERE WAS NOT ANY NOTICEABLE DAMAGE TO THE DEVICE AND DEVICE WAS NOT MANIPULATED IN ANY WAY. DEVICE WAS STORED IN PACKAGE ON SHELF. HEMOSTASIS WAS ACHIEVED WITH A SECOND TR BAND. THE PATIENT WAS STABLE (GOOD), AND THE BLOOD LOSS WAS LESS THAN 250CC. NO EQUIPMENT OR OTHER DEVICES WERE USED WITH THE TR BAND.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25017234 ↗MalfunctionApr 24, 2026Gas/Air Leak; Unintended Deflation
TERUMO MEDICAL CORPORATION RECEIVED THE FOLLOWING INFORMATION: IT WAS REPORTED THE TR BAND SPONTANEOUSLY LEAKED AIR. THERE WAS NO BLOOD LOSS. THE PROCEDURE PERFORMED PRIOR TO THE USE OF THE TR BAND WAS A RADIAL CATHETER PROCEDURE. ON 09APR2026 TERUMO MEDICAL RECEIVED AN FDA MEDWATCH REPORT # (B)(4). THE EVENT DESCRIPTION STATES: "TERUMO TR BANDS SPONTANEOUSLY FAILED DURING USE." THE INTENDED PROCEDURE WAS ANGIOGRAPHY - CORONARY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24975348 ↗MalfunctionApr 24, 2026Gas/Air Leak; Unintended Deflation
TERUMO MEDICAL CORPORATION RECEIVED THE FOLLOWING INFORMATION: IT WAS REPORTED THE TR BAND SPONTANEOUSLY LEAKED AIR. THERE WAS NO BLOOD LOSS. THE PROCEDURE PERFORMED PRIOR TO THE USE OF THE TR BAND WAS A RADIAL CATHETER PROCEDURE. ON 09APR2026 TERUMO MEDICAL RECEIVED AN FDA MEDWATCH REPORT # (B)(4). THE EVENT DESCRIPTION STATES: "TERUMO TR BANDS SPONTANEOUSLY FAILED DURING USE." THE INTENDED PROCEDURE WAS ANGIOGRAPHY - CORONARY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24975347 ↗MalfunctionApr 15, 2026Deflation Problem; Gas/Air Leak
TERUMO MEDICAL CORPORATION RECEIVED THE FOLLOWING REPORTED INFORMATION: WHEN THE TR BAND WAS APPLIED, 16 ML'S AIR WAS INJECTED INTO THE BAND. WITHIN MINUTES WHEN THE PACU RN WENT TO TITRATE AIR, THERE WAS NO AIR IN THE BACK. THE BALLOONS DEFLATED ON THEIR OWN. THERE WAS NO HARM TO PATIENT. IT WAS UNCLEAR WHERE THE LEAK CAME FROM. HEMOSTASIS WAS ACHIEVED ONLY FOR A FEW MINUTES BEFORE THE BALLOONS STARTED TO DEFLATE ON THEIR OWN. THE BLOOD LOSS WAS LESS THAN 250CC. THEY WERE UNABLE TO DETERMINE THE LEAK LOCATION WITHOUT THE QUALITY TEAM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24886467 ↗MalfunctionApr 3, 2026Gas/Air Leak; Unintended Deflation
TERUMO MEDICAL CORPORATION RECEIVED THE FOLLOWING INFORMATION: IT WAS REPORTED THAT AFTER THE LEFT HEART CATHETERIZATION PROCEDURE THE TR BAND WAS PLACED AND THE BALLOONS WERE INFLATED BY THE HEALTHCARE PROFESSIONAL WITH 18ML OF AIR, HOWEVER WHEN THE SYRINGE WAS REMOVED THE TR BAND IMMEDIATELY DEFLATED. THE TR BAND WAS REMOVED, AND A NEW TR BAND WAS OPENED AND PLACED SUCCESSFULLY AND DID NOT LEAK. THE WAS NO PATIENT HARM AND THE PATIENT REMAINED IN STABLE CONDITION. THERE WAS NO BLOOD LOSS. GLIDESHEATH SLENDER WAS USED IN THE ACCESS SITE. THE TR BAND WAS STORED PRIOR TO USE IN NORMAL TEMPERATURE-CONTROLLED CONDITIONS.
Patient problems: Hematoma; No Clinical Signs, Symptoms or Conditions
MAUDE report 24784268 ↗MalfunctionApr 3, 2026Deflation Problem; Gas/Air Leak
TERUMO MEDICAL CORPORATION RECEIVED THE FOLLOWING REPORTED INFORMATION: POST CEREBRAL ANGIOGRAM, THE TR BAND WAS STATED TO HAVE 17 ML OF AIR IN BAND. IN THE PACU, THE PATIENT WAS COMPLAINING OF PAIN ABOVE TR BAND SITE, THEREFORE, THE DOCTOR LOOKED AT IT AND SAID IT WAS MUSCULAR THEREFORE IT'S MORE PAINFUL. THE PATIENT WAS GIVEN ICE PACKS AND NORCO TO HELP WITH PAIN. AT 1000, AIR WAS DUE TO START COMING OUT OF TR BAND. WHEN I STARTED TO TAKE AIR OUT OF THE BAND, ONLY 1 ML CAME OUT. THEY ATTEMPTED TO REPLACE THE SYRINGE ON THE BAND; HOWEVER, NO MORE AIR CAME OUT. IT WAS CONFIRMED THERE WAS NO AIR IN THE BAND, AND THE DOCTOR WAS IMMEDIATELY NOTIFIED. THE BAND WAS TAKEN OFF, AND PRESSURE WAS HELD FOR 10 MINUTES. TR BAND WAS TAKEN OFF AND INFLATED TO 17 ML TO SEE IF AIR WOULD STAY IN THE BAND. AFTER 20 MINUTES, HALF OF THE AIR HAD DEFLATED. PRESSURE WAS HELD FROM 1011 TO 1035, THEN THE DOCTOR CAME OUT AND ASSESSED THE SITE AT 1035. HE CONFIRMED THAT THE TR BAND HAD A LEAK IN IT. THE DOCTOR LET THE PATIENT GET UP TO GO TO THE BATHROOM AND HE WOULD BE BACK TO CHECK THE SITE AFTER. A PRIMAPORE WAS PLACED ON THE PATIENT AND SHE WALKED TO THE BATHROOM. THE PATIENT WALKED BACK TO HER BED WITH
Patient problems: Pain
MAUDE report 24778430 ↗MalfunctionMar 31, 2026Gas/Air Leak
TERUMO MEDICAL CORPORATION RECEIVED THE FOLLOWING REPORTED INFORMATION: FOLLOWING A CATH LAB PROCEDURE, THE TR BAND DID NOT HOLD AIR; HOWEVER, IT STOPPED THE BLEEDING. THERE WAS NO NOTICEABLE DAMAGE TO THE DEVICE. THE TR BAND WAS REPLACED BY ANOTHER TR BAND THAT WORKED FINE. THE DEVICE WAS NOT MANIPULATED BEFORE USE IN ANY WAY - PRE-USE OR DURING STORAGE. THE PRODUCT WAS STORED ON THE SHELF. THERE WAS NO PATIENT HARM OR BLOOD LOSS REPORTED. THERE WERE NO OTHER DEVICES USED IN THE ACCESS SITE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24743765 ↗MalfunctionMar 17, 2026Deflation Problem; Unintended Deflation
TERUMO MEDICAL CORPORATION RECEIVED THE FOLLOWING REPORTED INFORMATION: THE TR BAND WAS PUT ON AND INFLATED AS THE RADIAL SHEATH WAS REMOVED. WHEN CHECKED A FEW MOMENTS LATER BY THE PHYSICIAN, THE LARGE BALLOON HAD DEFLATED AND WAS BLEEDING AT THE RADIAL PUNCTURE SITE AND AROUND THE PATIENT'S WRIST. ORIGINALLY 18 ML'S WERE INJECTED, AND ONCE AIR WAS TITRATED OUT 13 ML'S REMAINED. THE PHYSICIAN REINFLATED AND IT QUICKLY DEFLATED AGAIN. AT THIS TIME, THEY REMOVED THE CURRENT TR BAND, REPLACED IT WITH ANOTHER TR BAND, AND HEMOSTASIS WAS MAINTAINED. IT WAS NOT KNOWN IF THE NEW TR BAND PLACED AFTER THE DEFLATED BAND WAS FROM THE SAME LOT. THE BLOOD LOSS WAS LESS THAN 250CC. THE PROCEDURE BEING PERFORMED WAS A LEFT HEART CATH - RADIAL ACCESS. THE DEVICE WAS NOT PREVIOUSLY MANIPULATED. THERE WERE NO ADDITIONAL DEVICES USED IN CONJUNCTION WITH THE TR BAND. THE PRODUCT STORED ON THE SHELF IN THE CATH LAB. DRY ENVIRONMENT AND NOT IN DIRECT LIGHT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24619585 ↗MalfunctionNov 21, 2025Deflation Problem; Deflation Problem
TERUMO MEDICAL CORPORATION RECEIVED THE FOLLOWING REPORTED INFORMATION: TR BAND WAS PLACED ON THE PATIENT'S WRIST PER PROTOCOL. THE TR BAND BEGAN DEFLATING AFTER IT WAS PLACED. AN ATTEMPT WAS MADE TO REINFLATE THE TR BAND AND IT WOULD NOT STAY INFLATED. PRESSURE WAS HELD WHILE A NEW TR BAND WAS PLACED SUCCESSFULLY. THE PATIENT DID WELL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23617719 ↗MalfunctionAug 25, 2025Gas/Air Leak; Gas/Air Leak
THE USER FACILITY REPORTED THAT THE TR BAND SLOWLY LEAKED AFTER APPLICATION AND INFLATION. THE PROCEDURE PERFORMED PRIOR TO THE USE OF THE TR BAND WAS A HEART CATHETERIZATION. THERE WAS NO BLOOD LOSS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22889205 ↗MalfunctionAug 13, 2025Gas/Air Leak; Gas/Air Leak
THE USER FACILITY REPORTED THAT UPON COMPLETING A CARDIAC CATHETERIZATION THE TR BAND WAS PLACED ON THE PATIENT AND THE SHEATH WAS REMOVED PER PROTOCOL. THE TR BAND DID NOT HOLD PRESSURE, SO THE BAND WAS REMOVED AND REPLACED WITH ANOTHER TR BAND WITH THE SAME LOT NUMBER AND THE NEW TR BAND PERFORMED AS INTENDED. THERE WAS NO BLOOD LOSS. ADDITIONAL INFORMATION WAS RECEIVED ON 21JUL2025: 18ML'S OF AIR WERE INJECTED INTO THE TR BAND WHEN IT WAS APPLIED. THE TR BAND STARTED TO DEFLATE IMMEDIATELY. THE PATIENT WAS STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22801385 ↗MalfunctionAug 13, 2025Gas/Air Leak; Gas/Air Leak
THE USER FACILITY REPORTED THAT UPON COMPLETING A CARDIAC CATHETERIZATION THE TR BAND WAS PLACED ON THE PATIENT AND THE SHEATH WAS REMOVED PER PROTOCOL. THE TR BAND DID NOT HOLD PRESSURE, SO THE BAND WAS REMOVED AND REPLACED WITH ANOTHER TR BAND WITH THE SAME LOT NUMBER AND THE NEW TR BAND PERFORMED AS INTENDED. THERE WAS NO BLOOD LOSS. ADDITIONAL INFORMATION WAS RECEIVED ON 21JUL2025: 18ML'S OF AIR WERE INJECTED INTO THE TR BAND WHEN IT WAS APPLIED. THE TR BAND STARTED TO DEFLATE IMMEDIATELY. THE PATIENT WAS STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22801384 ↗MalfunctionJun 4, 2025Gas/Air Leak; Gas/Air Leak
THE USER FACILITY REPORTED THAT THE TECH PLACED THE FIRST TR BAND ON THE PATIENT. THE DEVICE WAS INFLATED WITH AIR AND TOOK THE SHEATH OUT AT SAME TIME. WHEN SHE DISCONNECTED THE SYRINGE FROM THE TR BAND, SHE ONLY HAD ONE HAND AVAILABLE, SO SHE JUST PULLED THE SYRINGE OFF OF THE PORT. SHE THEN NOTICED THAT THE SITE WAS BLEEDING. SHE PUT A SECOND TR BAND ON. SHE WAS ABLE TO USE TWO HANDS AND TOOK THE SYRINGE OFF CORRECTLY HOWEVER, NOTICED THAT THE SECOND BAND WAS NOT HOLDING AIR AND THE PATIENT STARTED TO BLEED. A THIRD TR BAND WAS PLACED AND HAD HEMOSTASIS. THE TECH DID NOT INFLATE EITHER THE BAND BEFORE PLACING ON THE PATIENT. THE PATIENT DID NOT GET A HEMATOMA. THE PROCEDURE WAS A SUDDEN CARDIAC ARREST (SCA). PATIENT WAS STABLE. RELEVANT TESTS WERE SELECTIVE CORONARY ANGIOGRAM. THERE WAS NO BLOOD LOSS. ADDITIONAL INFORMATION WAS RECEIVED ON 15MAY2025: BOTH TR BANDS ARE LARGE BANDS. THE FIRST TR BAND SEEMED TO BE HOLDING AIR AT FIRST, HOWEVER IT LOST AIR AFTER IT WAS INFLATED. THE TECH INFLATED AIR LIKE NORMAL. THEY GOT ACCESS AT ANOTHER SIGHT SO WHEN SHE WENT TO LOOK AT THE ACCESS SITE OF THE FIRST TR BAND IT WAS BLEEDING. THE SECOND TR BAND SHE NOTICED WAS LOSING AIR IMMEDIATELY
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22144472 ↗MalfunctionJun 4, 2025Gas/Air Leak; Gas/Air Leak
THE USER FACILITY REPORTED THAT THE TECH PLACED THE FIRST TR BAND ON THE PATIENT. THE DEVICE WAS INFLATED WITH AIR AND TOOK THE SHEATH OUT AT SAME TIME. WHEN SHE DISCONNECTED THE SYRINGE FROM THE TR BAND, SHE ONLY HAD ONE HAND AVAILABLE, SO SHE JUST PULLED THE SYRINGE OFF OF THE PORT. SHE THEN NOTICED THAT THE SITE WAS BLEEDING. SHE PUT A SECOND TR BAND ON. SHE WAS ABLE TO USE TWO HANDS AND TOOK THE SYRINGE OFF CORRECTLY HOWEVER, NOTICED THAT THE SECOND BAND WAS NOT HOLDING AIR AND THE PATIENT STARTED TO BLEED. A THIRD TR BAND WAS PLACED AND HAD HEMOSTASIS. THE TECH DID NOT INFLATE EITHER THE BAND BEFORE PLACING ON THE PATIENT. THE PATIENT DID NOT GET A HEMATOMA. THE PROCEDURE WAS A SUDDEN CARDIAC ARREST (SCA). PATIENT WAS STABLE. RELEVANT TESTS WERE SELECTIVE CORONARY ANGIOGRAM. THERE WAS NO BLOOD LOSS. ADDITIONAL INFORMATION WAS RECEIVED ON 15MAY2025: BOTH TR BANDS ARE LARGE BANDS. THE FIRST TR BAND SEEMED TO BE HOLDING AIR AT FIRST, HOWEVER IT LOST AIR AFTER IT WAS INFLATED. THE TECH INFLATED AIR LIKE NORMAL. THEY GOT ACCESS AT ANOTHER SIGHT SO WHEN SHE WENT TO LOOK AT THE ACCESS SITE OF THE FIRST TR BAND IT WAS BLEEDING. THE SECOND TR BAND SHE NOTICED WAS LOSING AIR IMMEDIATELY
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22144471 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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