Impress® 00884450009413Recalls & reported problems
Merit Medical Systems, Inc. · Class 2
All models of Impress (145)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00884450009413), received between Aug 7, 2023 and Aug 7, 2023 — classified as 1 injury.
The most frequently reported specific device problem is “Fracture” (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 16, 2026.
Most reported problems
Device problems
- Fracture1
- Material Separation1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 7, 2023Fracture; Material Separation; Fracture; Material Separation
THE ACCOUNT ALLEGES THAT DURING AN ENDOVASCULAR THERAPY FOR STENOSIS WITHIN THE RIGHT COMMON ILIAC ARTERY, THE TIP OF THE CATHETER DETACHED AND REMAINED IN THE ARTERY OF THE PATIENT'S BODY. THE TIP WAS RETRIEVED. THE PHYSICIAN STATED THAT THE PATIENT'S VESSEL HAD SLIGHT TORTUOSITY AND CALCIFICATION. THE PHYSICIAN STATED THAT THE CATHETER WAS ROTATED IN ONE DIRECTION TOO MUCH, AND IT COULD HAVE CAUSED THE DETACHMENT. NO INFORMATION WAS PROVIDED ON HOW THE DETACHED TIP WAS RETRIEVED FROM THIS PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17475746 ↗
Other CATHETER, INTRAVASCULAR, DIAGNOSTIC devices
- TrapEase Permanent Vena Cava Filter with the VisEase Angiographic Vessel Dilator 466P306AUCordis Corporation · CATHETER, INTRAVASCULAR, DIAGNOSTIC6 deaths186 reports
- Dragonfly™ OPTIS™ C408646Lightlab Imaging, Inc. · CATHETER, INTRAVASCULAR, DIAGNOSTIC4 deaths150 reports
- Dragonfly OpStar™ 1014651Lightlab Imaging, Inc. · CATHETER, INTRAVASCULAR, DIAGNOSTIC1 recall87 reports
- LANGSTON IPN913559Teleflex Incorporated · CATHETER, INTRAVASCULAR, DIAGNOSTIC2 recalls14 reports
- Trevo 90238Stryker Corporation · CATHETER, INTRAVASCULAR, DIAGNOSTIC2 recalls5 reports
- Expo™ H749085263011Boston Scientific Corporation · CATHETER, INTRAVASCULAR, DIAGNOSTIC2 recalls3 reports
- Expo™ H74908526501Boston Scientific Corporation · CATHETER, INTRAVASCULAR, DIAGNOSTIC2 recalls1 report
- Expo™ H74908526031Boston Scientific Corporation · CATHETER, INTRAVASCULAR, DIAGNOSTIC2 recalls0 reports
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page