Impress® 00884450120989Recalls & 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
- 7
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00884450120989), received between Oct 5, 2021 and Oct 6, 2021 — classified as 7 malfunctions.
The most frequently reported specific device problem is “Fracture” (7 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
Device problems
- Fracture7
- Material Separation7
Patient problems
- No Clinical Signs, Symptoms or Conditions7
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 6, 2021Fracture; Material Separation; Fracture; Material Separation
THE ACCOUNT ALLEGES THAT THE TIP OF THE CATHETER DETACHED WITHIN THE PATIENT WHILE STILL ON THE GUIDEWIRE. THIS OCCURED WHEN NEEDING TO TORQUE THE CATHETER AT A 45-90 DEGREE ANGLE TO OPACIFY ARTERIAL ANASTOMOSIS/OSTIUM. TIP OF THE CATHETER WAS SUCCESSFULLY REMOVED BY THE PROVIDER. NO PATIENT INJURY TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12585709 ↗MalfunctionOct 5, 2021Fracture; Material Separation; Fracture; Material Separation
THE ACCOUNT ALLEGES THAT THE TIP OF THE CATHETER DETACHED WITHIN THE PATIENT WHILE STILL ON THE GUIDEWIRE. THIS OCCURED WHEN NEEDING TO TORQUE THE CATHETER AT A 45-90 DEGREE ANGLE TO OPACIFY ARTERIAL ANASTOMOSIS/OSTIUM. TIP OF THE CATHETER WAS SUCCESSFULLY REMOVED BY THE PROVIDER. NO PATIENT INJURY TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12576894 ↗MalfunctionOct 5, 2021Fracture; Material Separation; Fracture; Material Separation
THE ACCOUNT ALLEGES THAT THE TIP OF THE CATHETER DETACHED WITHIN THE PATIENT WHILE STILL ON THE GUIDEWIRE. THIS OCCURED WHEN NEEDING TO TORQUE THE CATHETER AT A 45-90 DEGREE ANGLE TO OPACIFY ARTERIAL ANASTOMOSIS/OSTIUM. TIP OF THE CATHETER WAS SUCCESSFULLY REMOVED BY THE PROVIDER. NO PATIENT INJURY TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12576884 ↗MalfunctionOct 5, 2021Fracture; Material Separation; Fracture; Material Separation
THE ACCOUNT ALLEGES THAT THE TIP OF THE CATHETER DETACHED WITHIN THE PATIENT WHILE STILL ON THE GUIDEWIRE. THIS OCCURED WHEN NEEDING TO TORQUE THE CATHETER AT A 45-90 DEGREE ANGLE TO OPACIFY ARTERIAL ANASTOMOSIS/OSTIUM. TIP OF THE CATHETER WAS SUCESSFULLY REMOVED BY THE PROVIDER. NO PATIENT INJURY TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12576883 ↗MalfunctionOct 5, 2021Fracture; Material Separation; Fracture; Material Separation
THE ACCOUNT ALLEGES THAT THE TIP OF THE CATHETER DETACHED WITHIN THE PATIENT WHILE STILL ON THE GUIDEWIRE. THIS OCCURED WHEN NEEDING TO TORQUE THE CATHETER AT A 45-90 DEGREE ANGLE TO OPACIFY ARTERIAL ANASTOMOSIS/OSTIUM. TIP OF THE CATHETER WAS SUCESSFULLY REMOVED BY THE PROVIDER. NO PATIENT INJURY TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12576881 ↗MalfunctionOct 5, 2021Fracture; Material Separation; Fracture; Material Separation
THE ACCOUNT ALLEGES THAT THE TIP OF THE CATHETER DETACHED WITHIN THE PATIENT WHILE STILL ON THE GUIDEWIRE. THIS OCCURED WHEN NEEDING TO TORQUE THE CATHETER AT A 45-90 DEGREE ANGLE TO OPACIFY ARTERIAL ANASTOMOSIS/OSTIUM. TIP OF THE CATHETER WAS SUCCESSFULLY REMOVED BY THE PROVIDER. NO PATIENT INJURY TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12576880 ↗MalfunctionOct 5, 2021Fracture; Material Separation; Fracture; Material Separation
THE ACCOUNT ALLEGES THAT THE TIP OF THE CATHETER DETACHED WITHIN THE PATIENT WHILE STILL ON THE GUIDEWIRE. THIS OCCURED WHEN NEEDING TO TORQUE THE CATHETER AT A 45-90 DEGREE ANGLE TO OPACIFY ARTERIAL ANASTOMOSIS/OSTIUM. TIP OF THE CATHETER WAS SUCCESSFULLY REMOVED BY THE PROVIDER. NO PATIENT INJURY TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12576878 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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