Merit Medical® 00884450476673Recalls & reported problems
Merit Medical Systems, Inc. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Merit Medical angiography kit is a set of supplies used for artery imaging and treatment procedures. The 24 reports all describe outer packaging that was open or weakly sealed, letting the inner blue table cover fall out. The reports mention no deaths and no injuries, and no recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 24
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 00884450476673), received between Nov 11, 2020 and Nov 11, 2020 — classified as 24 malfunctions.
The most frequently reported specific device problem is “Unsealed Device Packaging” (24 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 18, 2026.
Most reported problems
Device problems
- No Apparent Adverse Event24
- Unsealed Device Packaging24
Patient problems
- No Clinical Signs, Symptoms or Conditions24
Recent adverse event reports
The 24 most recent of 24 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 11, 2020Unsealed Device Packaging; No Apparent Adverse Event; Unsealed Device Packaging; No Apparent Adverse Event
THE ACCOUNT ALLEGES THAT THE INNER BLUE TABLE COVER WRAP HAS FALLEN OUT OF THE OUTER CLEAR PACKAGING BECAUSE THE PACK WAS NOT SEALED CORRECTLY AT ONE END. SOME PACKS ALSO HAVE A WEAK SEAL. THE BLUE TABLE COVER WILL FALL OUT ONTO THE FLOOR IF THE PACK IS HELD AT THE WRONG END WHEN REMOVING THE PACK FROM THE SHIPPING BOX OR THE STORAGE SHELF. NO PATIENT INJURY TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10823428 ↗MalfunctionNov 11, 2020Unsealed Device Packaging; No Apparent Adverse Event; Unsealed Device Packaging; No Apparent Adverse Event
THE ACCOUNT ALLEGES THAT THE INNER BLUE TABLE COVER WRAP HAS FALLEN OUT OF THE OUTER CLEAR PACKAGING BECAUSE THE PACK WAS NOT SEALED CORRECTLY AT ONE END. SOME PACKS ALSO HAVE A WEAK SEAL. THE BLUE TABLE COVER WILL FALL OUT ONTO THE FLOOR IF THE PACK IS HELD AT THE WRONG END WHEN REMOVING THE PACK FROM THE SHIPPING BOX OR THE STORAGE SHELF. NO PATIENT INJURY TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10823423 ↗MalfunctionNov 11, 2020Unsealed Device Packaging; No Apparent Adverse Event; Unsealed Device Packaging; No Apparent Adverse Event
THE ACCOUNT ALLEGES THAT THE INNER BLUE TABLE COVER WRAP HAS FALLEN OUT OF THE OUTER CLEAR PACKAGING BECAUSE THE PACK WAS NOT SEALED CORRECTLY AT ONE END. SOME PACKS ALSO HAVE A WEAK SEAL. THE BLUE TABLE COVER WILL FALL OUT ONTO THE FLOOR IF THE PACK IS HELD AT THE WRONG END WHEN REMOVING THE PACK FROM THE SHIPPING BOX, OR THE STORAGE SHELF. NO PATIENT INJURY TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10823421 ↗MalfunctionNov 11, 2020Unsealed Device Packaging; No Apparent Adverse Event; Unsealed Device Packaging; No Apparent Adverse Event
THE ACCOUNT ALLEGES THAT THE INNER BLUE TABLE COVER WRAP HAS FALLEN OUT OF THE OUTER CLEAR PACKAGING BECAUSE THE PACK WAS NOT SEALED CORRECTLY AT ONE END. SOME PACKS ALSO HAVE A WEAK SEAL. THE BLUE TABLE COVER WILL FALL OUT ONTO THE FLOOR IF THE PACK IS HELD AT THE WRONG END WHEN REMOVING THE PACK FROM THE SHIPPING BOX OR THE STORAGE SHELF. NO PATIENT INJURY TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10823419 ↗MalfunctionNov 11, 2020Unsealed Device Packaging; No Apparent Adverse Event; Unsealed Device Packaging; No Apparent Adverse Event
THE ACCOUNT ALLEGES THAT THE INNER BLUE TABLE COVER WRAP HAS FALLEN OUT OF THE OUTER CLEAR PACKAGING BECAUSE THE PACK WAS NOT SEALED CORRECTLY AT ONE END. SOME PACKS ALSO HAVE A WEAK SEAL. THE BLUE TABLE COVER WILL FALL OUT ONTO THE FLOOR IF THE PACK IS HELD AT THE WRONG END WHEN REMOVING THE PACK FROM THE SHIPPING BOX OR THE STORAGE SHELF. NO PATIENT INJURY TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10823418 ↗MalfunctionNov 11, 2020Unsealed Device Packaging; No Apparent Adverse Event; Unsealed Device Packaging; No Apparent Adverse Event
THE ACCOUNT ALLEGES THAT THE INNER BLUE TABLE COVER WRAP HAS FALLEN OUT OF THE OUTER CLEAR PACKAGING BECAUSE THE PACK WAS NOT SEALED CORRECTLY AT ONE END. SOME PACKS ALSO HAVE A WEAK SEAL. THE BLUE TABLE COVER WILL FALL OUT ONTO THE FLOOR IF THE PACK IS HELD AT THE WRONG END WHEN REMOVING THE PACK FROM THE SHIPPING BOX OR THE STORAGE SHELF. NO PATIENT INJURY TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10823417 ↗MalfunctionNov 11, 2020Unsealed Device Packaging; No Apparent Adverse Event; Unsealed Device Packaging; No Apparent Adverse Event
THE ACCOUNT ALLEGES THAT THE INNER BLUE TABLE COVER WRAP HAS FALLEN OUT OF THE OUTER CLEAR PACKAGING BECAUSE THE PACK WAS NOT SEALED CORRECTLY AT ONE END. SOME PACKS ALSO HAVE A WEAK SEAL. THE BLUE TABLE COVER WILL FALL OUT ONTO THE FLOOR IF THE PACK IS HELD AT THE WRONG END WHEN REMOVING THE PACK FROM THE SHIPPING BOX OR THE STORAGE SHELF. NO PATIENT INJURY TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10823416 ↗MalfunctionNov 11, 2020Unsealed Device Packaging; No Apparent Adverse Event; Unsealed Device Packaging; No Apparent Adverse Event
THE ACCOUNT ALLEGES THAT THE INNER BLUE TABLE COVER WRAP HAS FALLEN OUT OF THE OUTER CLEAR PACKAGING BECAUSE THE PACK WAS NOT SEALED CORRECTLY AT ONE END. SOME PACKS ALSO HAVE A WEAK SEAL. THE BLUE TABLE COVER WILL FALL OUT ONTO THE FLOOR IF THE PACK IS HELD AT THE WRONG END WHEN REMOVING THE PACK FROM THE SHIPPING BOX OR THE STORAGE SHELF. NO PATIENT INJURY TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10823415 ↗MalfunctionNov 11, 2020Unsealed Device Packaging; No Apparent Adverse Event; Unsealed Device Packaging; No Apparent Adverse Event
THE ACCOUNT ALLEGES THAT THE INNER BLUE TABLE COVER WRAP HAS FALLEN OUT OF THE OUTER CLEAR PACKAGING BECAUSE THE PACK WAS NOT SEALED CORRECTLY AT ONE END. SOME PACKS ALSO HAVE A WEAK SEAL. THE BLUE TABLE COVER WILL FALL OUT ONTO THE FLOOR IF THE PACK IS HELD AT THE WRONG END WHEN REMOVING THE PACK FROM THE SHIPPING BOX OR THE STORAGE SHELF. NO PATIENT INJURY TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10823412 ↗MalfunctionNov 11, 2020Unsealed Device Packaging; No Apparent Adverse Event; Unsealed Device Packaging; No Apparent Adverse Event
THE ACCOUNT ALLEGES THAT THE INNER BLUE TABLE COVER WRAP HAS FALLEN OUT OF THE OUTER CLEAR PACKAGING BECAUSE THE PACK WAS NOT SEALED CORRECTLY AT ONE END. SOME PACKS ALSO HAVE A WEAK SEAL. THE BLUE TABLE COVER WILL FALL OUT ONTO THE FLOOR IF THE PACK IS HELD AT THE WRONG END WHEN REMOVING THE PACK FROM THE SHIPPING BOX OR THE STORAGE SHELF. NO PATIENT INJURY TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10823411 ↗MalfunctionNov 11, 2020Unsealed Device Packaging; No Apparent Adverse Event; Unsealed Device Packaging; No Apparent Adverse Event
THE ACCOUNT ALLEGES THAT THE INNER BLUE TABLE COVER WRAP HAS FALLEN OUT OF THE OUTER CLEAR PACKAGING BECAUSE THE PACK WAS NOT SEALED CORRECTLY AT ONE END. SOME PACKS ALSO HAVE A WEAK SEAL. THE BLUE TABLE COVER WILL FALL OUT ONTO THE FLOOR IF THE PACK IS HELD AT THE WRONG END WHEN REMOVING THE PACK FROM THE SHIPPING BOX OR THE STORAGE SHELF. NO PATIENT INJURY TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10823410 ↗MalfunctionNov 11, 2020Unsealed Device Packaging; No Apparent Adverse Event; Unsealed Device Packaging; No Apparent Adverse Event
THE ACCOUNT ALLEGES THAT THE INNER BLUE TABLE COVER WRAP HAS FALLEN OUT OF THE OUTER CLEAR PACKAGING BECAUSE THE PACK WAS NOT SEALED CORRECTLY AT ONE END. SOME PACKS ALSO HAVE A WEAK SEAL. THE BLUE TABLE COVER WILL FALL OUT ONTO THE FLOOR IF THE PACK IS HELD AT THE WRONG END WHEN REMOVING THE PACK FROM THE SHIPPING BOX OR THE STORAGE SHELF. NO PATIENT INJURY TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10823409 ↗MalfunctionNov 11, 2020Unsealed Device Packaging; No Apparent Adverse Event; Unsealed Device Packaging; No Apparent Adverse Event
THE ACCOUNT ALLEGES THAT THE INNER BLUE TABLE COVER WRAP HAS FALLEN OUT OF THE OUTER CLEAR PACKAGING BECAUSE THE PACK WAS NOT SEALED CORRECTLY AT ONE END. SOME PACKS ALSO HAVE A WEAK SEAL. THE BLUE TABLE COVER WILL FALL OUT ONTO THE FLOOR IF THE PACK IS HELD AT THE WRONG END WHEN REMOVING THE PACK FROM THE SHIPPING BOX OR THE STORAGE SHELF. NO PATIENT INJURY TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10823408 ↗MalfunctionNov 11, 2020Unsealed Device Packaging; No Apparent Adverse Event; Unsealed Device Packaging; No Apparent Adverse Event
THE ACCOUNT ALLEGES THAT THE INNER BLUE TABLE COVER WRAP HAS FALLEN OUT OF THE OUTER CLEAR PACKAGING BECAUSE THE PACK WAS NOT SEALED CORRECTLY AT ONE END. SOME PACKS ALSO HAVE A WEAK SEAL. THE BLUE TABLE COVER WILL FALL OUT ONTO THE FLOOR IF THE PACK IS HELD AT THE WRONG END WHEN REMOVING THE PACK FROM THE SHIPPING BOX OR THE STORAGE SHELF. NO PATIENT INJURY TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10823407 ↗MalfunctionNov 11, 2020Unsealed Device Packaging; No Apparent Adverse Event; Unsealed Device Packaging; No Apparent Adverse Event
THE ACCOUNT ALLEGES THAT THE INNER BLUE TABLE COVER WRAP HAS FALLEN OUT OF THE OUTER CLEAR PACKAGING BECAUSE THE PACK WAS NOT SEALED CORRECTLY AT ONE END. SOME PACKS ALSO HAVE A WEAK SEAL. THE BLUE TABLE COVER WILL FALL OUT ONTO THE FLOOR IF THE PACK IS HELD AT THE WRONG END WHEN REMOVING THE PACK FROM THE SHIPPING BOX OR THE STORAGE SHELF. NO PATIENT INJURY TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10823406 ↗MalfunctionNov 11, 2020Unsealed Device Packaging; No Apparent Adverse Event; Unsealed Device Packaging; No Apparent Adverse Event
THE ACCOUNT ALLEGES THAT THE INNER BLUE TABLE COVER WRAP HAS FALLEN OUT OF THE OUTER CLEAR PACKAGING BECAUSE THE PACK WAS NOT SEALED CORRECTLY AT ONE END. SOME PACKS ALSO HAVE A WEAK SEAL. THE BLUE TABLE COVER WILL FALL OUT ONTO THE FLOOR IF THE PACK IS HELD AT THE WRONG END WHEN REMOVING THE PACK FROM THE SHIPPING BOX OR THE STORAGE SHELF. NO PATIENT INJURY TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10823405 ↗MalfunctionNov 11, 2020Unsealed Device Packaging; No Apparent Adverse Event; Unsealed Device Packaging; No Apparent Adverse Event
THE ACCOUNT ALLEGES THAT THE INNER BLUE TABLE COVER WRAP HAS FALLEN OUT OF THE OUTER CLEAR PACKAGING BECAUSE THE PACK WAS NOT SEALED CORRECTLY AT ONE END. SOME PACKS ALSO HAVE A WEAK SEAL. THE BLUE TABLE COVER WILL FALL OUT ONTO THE FLOOR IF THE PACK IS HELD AT THE WRONG END WHEN REMOVING THE PACK FROM THE SHIPPING BOX OR THE STORAGE SHELF. NO PATIENT INJURY TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10823404 ↗MalfunctionNov 11, 2020Unsealed Device Packaging; No Apparent Adverse Event; Unsealed Device Packaging; No Apparent Adverse Event
THE ACCOUNT ALLEGES THAT THE INNER BLUE TABLE COVER WRAP HAS FALLEN OUT OF THE OUTER CLEAR PACKAGING BECAUSE THE PACK WAS NOT SEALED CORRECTLY AT ONE END. SOME PACKS ALSO HAVE A WEAK SEAL. THE BLUE TABLE COVER WILL FALL OUT ONTO THE FLOOR IF THE PACK IS HELD AT THE WRONG END WHEN REMOVING THE PACK FROM THE SHIPPING BOX OR THE STORAGE SHELF. NO PATIENT INJURY TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10823403 ↗MalfunctionNov 11, 2020Unsealed Device Packaging; No Apparent Adverse Event; Unsealed Device Packaging; No Apparent Adverse Event
THE ACCOUNT ALLEGES THAT THE INNER BLUE TABLE COVER WRAP HAS FALLEN OUT OF THE OUTER CLEAR PACKAGING BECAUSE THE PACK WAS NOT SEALED CORRECTLY AT ONE END. SOME PACKS ALSO HAVE A WEAK SEAL. THE BLUE TABLE COVER WILL FALL OUT ONTO THE FLOOR IF THE PACK IS HELD AT THE WRONG END WHEN REMOVING THE PACK FROM THE SHIPPING BOX OR THE STORAGE SHELF. NO PATIENT INJURY TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10823402 ↗MalfunctionNov 11, 2020Unsealed Device Packaging; No Apparent Adverse Event; Unsealed Device Packaging; No Apparent Adverse Event
THE ACCOUNT ALLEGES THAT THE INNER BLUE TABLE COVER WRAP HAS FALLEN OUT OF THE OUTER CLEAR PACKAGING BECAUSE THE PACK WAS NOT SEALED CORRECTLY AT ONE END. SOME PACKS ALSO HAVE A WEAK SEAL. THE BLUE TABLE COVER WILL FALL OUT ONTO THE FLOOR IF THE PACK IS HELD AT THE WRONG END WHEN REMOVING THE PACK FROM THE SHIPPING BOX OR THE STORAGE SHELF. NO PATIENT INJURY TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10823401 ↗MalfunctionNov 11, 2020Unsealed Device Packaging; No Apparent Adverse Event; Unsealed Device Packaging; No Apparent Adverse Event
THE ACCOUNT ALLEGES THAT THE INNER BLUE TABLE COVER WRAP HAS FALLEN OUT OF THE OUTER CLEAR PACKAGING BECAUSE THE PACK WAS NOT SEALED CORRECTLY AT ONE END. SOME PACKS ALSO HAVE A WEAK SEAL. THE BLUE TABLE COVER WILL FALL OUT ONTO THE FLOOR IF THE PACK IS HELD AT THE WRONG END WHEN REMOVING THE PACK FROM THE SHIPPING BOX OR THE STORAGE SHELF. NO PATIENT INJURY TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10823399 ↗MalfunctionNov 11, 2020Unsealed Device Packaging; No Apparent Adverse Event; Unsealed Device Packaging; No Apparent Adverse Event
THE ACCOUNT ALLEGES THAT THE INNER BLUE TABLE COVER WRAP HAS FALLEN OUT OF THE OUTER CLEAR PACKAGING BECAUSE THE PACK WAS NOT SEALED CORRECTLY AT ONE END. SOME PACKS ALSO HAVE A WEAK SEAL. THE BLUE TABLE COVER WILL FALL OUT ONTO THE FLOOR IF THE PACK IS HELD AT THE WRONG END WHEN REMOVING THE PACK FROM THE SHIPPING BOX OR THE STORAGE SHELF. NO PATIENT INJURY TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10823398 ↗MalfunctionNov 11, 2020Unsealed Device Packaging; No Apparent Adverse Event; Unsealed Device Packaging; No Apparent Adverse Event
THE ACCOUNT ALLEGES THAT THE INNER BLUE TABLE COVER WRAP HAS FALLEN OUT OF THE OUTER CLEAR PACKAGING BECAUSE THE PACK WAS NOT SEALED CORRECTLY AT ONE END. SOME PACKS ALSO HAVE A WEAK SEAL. THE BLUE TABLE COVER WILL FALL OUT ONTO THE FLOOR IF THE PACK IS HELD AT THE WRONG END WHEN REMOVING THE PACK FROM THE SHIPPING BOX, OR THE STORAGE SHELF. NO PATIENT INJURY TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10823397 ↗MalfunctionNov 11, 2020Unsealed Device Packaging; No Apparent Adverse Event; Unsealed Device Packaging; No Apparent Adverse Event
THE ACCOUNT ALLEGES THAT THE INNER BLUE TABLE COVER WRAP HAS FALLEN OUT OF THE OUTER CLEAR PACKAGING BECAUSE THE PACK WAS NOT SEALED CORRECTLY AT ONE END. SOME PACKS ALSO HAVE A WEAK SEAL. THE BLUE TABLE COVER WILL FALL OUT ONTO THE FLOOR IF THE PACK IS HELD AT THE WRONG END WHEN REMOVING THE PACK FROM THE SHIPPING BOX OR THE STORAGE SHELF. NO PATIENT INJURY TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10823391 ↗
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- Medline Industries, Inc. DYNJ40632CMedline Industries, Inc. · Angiography/angioplasty kit2 recalls1 report
- Merit Medical® 00884450140840Merit Medical Systems, Inc. · Angiography/angioplasty kit2 recalls0 reports
- Merit Medical® 00884450140796Merit Medical Systems, Inc. · Angiography/angioplasty kit2 recalls0 reports
- Medline Industries, Inc. DYNJ63542BMedline Industries, Inc. · Angiography/angioplasty kit2 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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