TR BANDRecalls & reported problems across all models

We found 4 models of TR BAND by Terumo Medical Corporation in the FDA's device registry (GUDID). Together they are named in 672 adverse event reports in the FDA's MAUDE database, received between Sep 15, 2016 and Sep 29, 2026 — classified as 143 injuries, 529 malfunctions.

The most frequently reported specific device problem is “Gas/Air Leak” (365 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 TR BAND problems

TR BAND models

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

• TR BAND TRB24-REG

  CLAMP, VASCULAR
  284 reports
• TR BAND TRB24-REG

  CLAMP, VASCULAR
  256 reports
• TR BAND TRB29-LRG

  CLAMP, VASCULAR
  67 reports
• TR BAND TRB29-LRG

  CLAMP, VASCULAR
  65 reports

Recent TR BAND adverse event reports

The 15 most recent reports across all models, 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 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 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 ↗

Other Terumo Medical Corporation products

• ANGIO-SEAL6 models · 2,352 reports
• GLIDESHEATH SLENDER13 models · 401 reports · 1 recall
• DESTINATION21 models · 223 reports
• R2P Destination Slender6 models · 198 reports
• PINNACLE35 models · 161 reports
• PINNACLE PRECISION ACCESS SYSTEM11 models · 83 reports
• GLIDESHEATH12 models · 35 reports