Skip to content

Dynamis AV D0804062475Recalls & reported problems

Creagh Medical Limited · Dynamis PTA UHP 8mm x 40mm x 75cm · Class 2

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05391525783284), received between Aug 15, 2019 and Aug 15, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Puncture/Hole” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Material Puncture/Hole1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1
  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionAug 15, 2019Material Puncture/Hole

    FOLLOW UP REPORT FOR (B)(6); MFR. REPORT #: 3005994106-2019-00009.

    Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

    MAUDE report 8896531 ↗

Other Catheter, Angioplasty, Peripheral, Transluminal devices

All Catheter, Angioplasty, Peripheral, Transluminal devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.