TR BAND TRB24-REG (UDI 00389701012469)Recalls & reported problems

Summary

The FDA's MAUDE database contains 256 adverse event reports that list this exact device (DI 00389701012469), received between May 11, 2023 and Sep 29, 2026 — classified as 34 injuries, 222 malfunctions.

The most frequently reported specific device problem is “Gas/Air Leak” (154 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 256 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Gas/Air Leak; Unintended Deflation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50935659 ↗
• MalfunctionSep 29, 2026Gas/Air Leak; Unintended Deflation

  Terumo Medical Corporation received the following information: It was reported that the TR Band was noted to be losing air approximately forty-five minutes after completion of the procedure while the patient was in the post-operative area. When the TR Band was removed off the patient, they inflated the balloons and when pressure was put on the balloons, they would deflate. There was no patient injury. Manual pressure was applied and hemostasis achieved. There was no blood loss. The patient remained stable. A total of 18 mL of air was injected into the TR Band when it was initially applied to the patient¿s wrist. The TR Band is typically left in place for sixty minutes before air titration begins for patients who receive less than fifty units of heparin, and for one hundred and twenty minutes for patients who receive more than fifty units of heparin. In this case, all of the air had already been lost from the TR Band when titration was initiated in the post-operative area. There was no noticeable damage to the device, and the device had not been manipulated in any way prior to use or during storage. Before use, the TR Band was stored in its original TR Band box on enclosed shelves.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50935370 ↗
• MalfunctionSep 23, 2026Gas/Air Leak; Unintended Deflation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50876089 ↗
• MalfunctionSep 23, 2026Gas/Air Leak; Unintended Deflation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50875720 ↗
• MalfunctionSep 18, 2026Gas/Air Leak

  Terumo received the following reported information: The TR Band would not hold air resulting in hematoma. The procedure performed was a Heart Cath. 15 mL of air was injected into the TR Band when applied. It was unknown where the air was leaking from, and there was no noticeable damage to the device. The device was not manipulated in any way, and the product was stored in original container box in a cath lab storage room.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50817268 ↗
• MalfunctionSep 16, 2026Unintended Deflation

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 50789144 ↗
• MalfunctionSep 15, 2026Gas/Air Leak; Unintended Deflation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50782129 ↗
• MalfunctionSep 15, 2026Gas/Air Leak

  Patient problems: Hematoma

  MAUDE report 50778224 ↗
• MalfunctionSep 15, 2026Gas/Air Leak

  Patient problems: Hematoma

  MAUDE report 50778006 ↗
• MalfunctionSep 15, 2026Gas/Air Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50775485 ↗
• MalfunctionSep 14, 2026Gas/Air Leak; Unintended Deflation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50757686 ↗
• MalfunctionSep 10, 2026Gas/Air Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50714888 ↗
• MalfunctionSep 10, 2026Gas/Air Leak; Unintended Deflation

  Patient problems: Hematoma

  MAUDE report 50714162 ↗
• MalfunctionSep 10, 2026Gas/Air Leak; Unintended Deflation

  Patient problems: Swelling/ Edema

  MAUDE report 50713927 ↗
• MalfunctionSep 10, 2026Gas/Air Leak; Unintended Deflation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50713159 ↗
• MalfunctionSep 9, 2026Gas/Air Leak

  Terumo received the following reported information: The patient was transferred from one hospital to another with the TR Band in place. The band had been titrated several times and the patient remained stable. The Registered Nurse (RN) had initiated the deflation process by removing 2 mL of air three times. About halfway through the titration process (two hours after inflation), staff noticed that the inflation mechanism appeared to be leaking. Due to the leak, the TR Band was removed, manual pressure was applied for approximately thirty (30) minutes, and a dressing was applied. Before the next deflation, the laboratory staff entered the room to draw blood and immediately returned to alert the team that the patient was bleeding from the radial access site. The patient experienced minor to moderate blood loss at the access site (less than 250cc), and small to moderate-sized hematoma. They attribute the minor blood loss to how frequently they performed assessments; therefore, they noticed the leak promptly. The patient remained stable, with no issues noted with heart rate or blood pressure. A 6 French Terumo radial sheath was used for vascular access. There was no obvious or noticeab

  Patient problems: Hematoma; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 50691617 ↗
• MalfunctionSep 9, 2026Gas/Air Leak; Unintended Deflation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50681082 ↗
• MalfunctionSep 3, 2026Gas/Air Leak

  Patient problems: Hematoma

  MAUDE report 50590771 ↗
• MalfunctionSep 2, 2026Gas/Air Leak; Unintended Deflation

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 50567961 ↗
• MalfunctionSep 2, 2026Gas/Air Leak; Unintended Deflation

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 50567382 ↗
• MalfunctionSep 1, 2026Gas/Air Leak; Unintended Deflation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50535879 ↗
• MalfunctionSep 1, 2026Gas/Air Leak; Unintended Deflation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50535710 ↗
• MalfunctionAug 31, 2026Gas/Air Leak

  Terumo received the following reported information: The original band was tested after it was removed from the patient, inserted 15cc of air and then removed the air later and only 13cc were left. It seemed the device was leaking air. Following replacement, no further signs of bleeding or hematoma were observed. No blood loss was reported. The product was stored within expectations.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50519486 ↗
• MalfunctionAug 27, 2026Gas/Air Leak; Unintended Deflation

  Terumo Medical Corporation received the following information: It was reported that the patient had a TR Band placed with 12mL of air post radial left heart catheterization. When they initially started to remove air per protocol no issues were noted, however they only removed 7mLs of air and the TR band was empty. Hemostasis was achieved by the TR Band. There was no blood loss and the patient remained in stable condition. The location of the leak is unclear.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50483570 ↗
• MalfunctionAug 24, 2026Deflation Problem; Gas/Air Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50412060 ↗