Trapper™ Exchange Device H74939330130Recalls & reported problems
Creganna Unlimited Company · Trapper™ Exchange Device · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05391526210154), received between Oct 24, 2022 and Jun 4, 2026 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Inflation Problem” (1 report).
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
- Inflation Problem1
- Material Rupture1
- Unstable1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Insufficient Information1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 4, 2026Material Rupture
IT WAS REPORTED THAT THE BALLOON RUPTURED. THE TARGET LESION WAS LOCATION IN THE CORONARY ARTERY. A TRAPPER EXCHANGE DEVICE WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE BALLOON BURST AT 18 ATM. THE DEVICE WAS REMOVED, AND 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 25402941 ↗MalfunctionSep 3, 2024Inflation Problem; Inflation Problem
REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 09AUG2024. IT WAS REPORTED THAT DEVICE FAILED TO INFLATE. THE TARGET LESION WAS LOCATED IN THE LEFT CORONARY ARTERY. A TRAPPER WAS SELECTED FOR USE. DURING THE PROCEDURE, THE BALLOON WAS INFLATED AT 12 ATMOSPHERES HOWEVER BALLOON INFLATION DID NOT MEET EXPECTATIONS. THE DEVICE WAS REMOVED, AND PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, DEVICE ANALYSIS REVEALED THAT A LEAK WAS OBSERVED FROM A PINHOLE BURST ON THE SHAFT APPROXIMATELY AT 905MM FROM THE CATHETER TIP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20131808 ↗MalfunctionOct 24, 2022Unstable
INFLATED TO 16ATM ON DEVICE WHILE IN A 6FR GUIDE CATHETER. TRAPPER WOULD NOT HOLD WIRE IN PLACE WHILE ATTEMPTING TO REMOVE MICRO CATHETER.
Patient problems: Insufficient Information
MAUDE report 15657365 ↗
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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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