Trapper™ H74939739130Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00191506048938), received between Mar 20, 2025 and Sep 10, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (6 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 10, 2026Fluid/Blood Leak; Inflation Problem; Material Rupture

  It was reported that a balloon rupture occurred.A Trapper Exchange Device was selected for use. At the course of the procedure, the device was advanced into the guide catheter to facilitate a microcatheter removal. However, it was noted that the balloon appeared to have a small hole that prevented adequate inflation. As the pressure in the inflation device was increased, the pressure gauge kept falling back down as the balloon lost pressure. Upon removing the device from the guide, the physician inspected it closely and saw a pinhole in the balloon which caused it to leak contrast during inflation. The procedure was completed with another of the same device. There were no patient complications.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50716782 ↗
• MalfunctionSep 18, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE HEART. A TRAPPER EXCHANGE DEVICE WAS SELECTED FOR USE. DURING THE PROCEDURE, BALLOON WAS INFLATED ONCE AND RUPTURED RIGHT AT 6 ATMOSPHERES. THE BALLOON WAS REMOVED FROM THE PATIENT BODY, AND THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23091554 ↗
• MalfunctionSep 17, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. DURING THE PROCEDURE, THE TRAPPER BALLOON WAS INFLATED TO 16 ATM BEFORE RUPTURING. THE PROCEDURE WAS COMPLETED WITH ANOTHER TRAPPER BALLOON. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23071309 ↗
• MalfunctionAug 20, 2025Material Rupture; Adverse Event Without Identified Device or Use Problem; Material Rupture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. A TRAPPER EXCHANGE DEVICE WAS SELECTED FOR USE. DURING THE PROCEDURE, THE BALLOON BURST. THE DEVICE WAS REMOVED FROM THE PATIENT BODY, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22856688 ↗
• MalfunctionApr 1, 2025Material Rupture; Material Rupture

  IT WAS NOTED THAT A BALLOON RUPTURE OCCURRED. THE PATIENT PRESENTED WITH CORONARY ARTERY DISEASE AND UNDERWENT PERCUTANEOUS CORONARY INTERVENTION. THE TARGET LESION WAS LOCATED IN THE CORONARY ARTERY. A TRAPPER EXCHANGE BALLOON WAS SELECTED FOR USE. DURING PREPARATION, IT WAS NOTED THAT THE BALLOON COULD NOT HOLD PRESSURE AS THE AIR BUBBLES WOULD NOT STOP COMING FROM THE CATHETER INTO THE SYRINGE DUE TO PINHOLE IN THE BALLOON. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21740630 ↗
• MalfunctionMar 20, 2025Mechanical Problem; Material Rupture; Difficult to Advance; Material Deformation; Mechanical Problem; Material Rupture; Difficult to Advance; Material Deformation

  IT WAS REPORTED THAT THE TRAPPER GOT A PINHOLE IN THE BALLOON. A TRAPPER EXCHANGE DEVICE WAS SELECTED FOR CHRONIC TOTAL OCCLUSION. DURING THE PROCEDURE, THE TRAPPER BENT GOING INTO THE COLLAR OF THE GUIDE EXTENSION. IT WOULD NOT ADVANCE PAST THE COLLAR OF THE GUIDEZILLA. THEN NOMINAL PRESSURE WAS APPLIED. THE TRAPPER POSSIBLY GOT A PINHOLE IN THE BALLOON WHILE TRYING TO GET PAST THE GUIDEZILLA AND CAUSING THE BALLOON TO NO LONGER HOLD THE WIRE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21658373 ↗