Skip to content

Dynamis AV D1404081675Recalls & reported problems

Creagh Medical Limited · Dynamis PTA UHP 14mm x 40mm x 75cm · Class 2

All models of Dynamis AV (8)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
4
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05391525783352), received between Jan 16, 2019 and May 26, 2021 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Difficult to Open or Close” (3 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

  • Difficult to Open or Close3
  • Failure to Deflate3
  • Failure to Fold3
  • Mechanical Jam3
  • Accessory Incompatible2
  • Component or Accessory Incompatibility1
  • Difficult to Remove1

Patient problems

  • Insufficient Information3
  • No Clinical Signs, Symptoms or Conditions3
  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMay 26, 2021Accessory Incompatible; Failure to Fold; Difficult to Open or Close; Mechanical Jam; Failure to Deflate; Accessory Incompatible; Failure to Fold; Difficult to Open or Close; Mechanical Jam; Failure to Deflate

    DURING PROCEDURE THE BALLOON DID NOT DEFLATE/ REFOLD CORRECTLY. THERE WAS DIFFICULTY IN RETRIEVAL AND GUIDE CATHETER TIP WAS DAMAGED. NO COMPLICATIONS OCCURED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11890698 ↗
  • MalfunctionMay 26, 2021Accessory Incompatible; Failure to Fold; Difficult to Open or Close; Mechanical Jam; Failure to Deflate; Accessory Incompatible; Failure to Fold; Difficult to Open or Close; Mechanical Jam; Failure to Deflate

    DURING PROCEDURE THE BALLOON DID NOT DEFLATE/ REFOLD CORRECTLY. THERE WAS DIFFICULTY IN RETRIEVAL AND GUIDE CATHETER TIP WAS DAMAGED. NO COMPLICATIONS OCCURED.

    Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

    MAUDE report 11890696 ↗
  • MalfunctionMay 26, 2021Failure to Fold; Component or Accessory Incompatibility; Difficult to Open or Close; Mechanical Jam; Failure to Deflate; Failure to Fold; Component or Accessory Incompatibility; Difficult to Open or Close; Mechanical Jam; Failure to Deflate

    DURING PROCEDURE THE BALLOON DID NOT DEFLATE/ REFOLD CORRECTLY. THERE WAS DIFFICULTY IN RETRIEVAL AND GUIDE CATHETER TIP WAS DAMAGED. NO COMPLICATIONS OCCURED.

    Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

    MAUDE report 11890683 ↗
  • MalfunctionJan 16, 2019Difficult to Remove

    THE CUSTOMER HAS REPORTED THAT THEY ARE NOT ABLE TO WITHDRAW THE BALLOONS THEY SHEATH. THEY ARE HAVING TO REMOVE THE SHEATH EACH TIME TO REMOVE THE BALLOON THEY SHEATH. THEY ARE HAVING TO REMOVE THE SHEATH EACH TIME TO REMOVE THE BALLOON. THE CUSTOMER HAS REPORTED THAT THIS HAS HAPPENED ON SEVERAL OCCASIONS, BUT HAVE NOT PROVIDED SPECIFIC DATES. NO HARM OR IMPACT TO ANY PATIENTS HAVE BEEN INDICATED BY THE CUSTOMER.

    Patient problems: Insufficient Information; No Known Impact Or Consequence To Patient

    MAUDE report 8252073 ↗

Other Catheter, Angioplasty, Peripheral, Transluminal devices

All Catheter, Angioplasty, Peripheral, Transluminal devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page