Dynamis AV D1004072075Recalls & reported problems
Creagh Medical Limited · Dynamis PTA UHP 10mm 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
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05391525783338), received between Feb 25, 2019 and Apr 28, 2020 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Difficult to Remove” (2 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 Remove2
- Deflation Problem1
- Device-Device Incompatibility1
- Difficult to Advance1
- Mechanical Jam1
- Retraction Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Insufficient Information1
- No Code Available1
- No Consequences Or Impact To Patient1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 28, 2020Deflation Problem; Retraction Problem; Device-Device Incompatibility; Mechanical Jam; Deflation Problem; Retraction Problem; Device-Device Incompatibility; Mechanical Jam
FOLLOW UP REPORT FOR (B)(6); MFR REPORT #: 3005994106-2020-00001
Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient
MAUDE report 10008109 ↗MalfunctionApr 11, 2019Difficult to Remove
AFTER THE PROPER BALLOON INFLATION AND DEFLATION TECHNIQUE WAS PERFORMED, WHEN TRYING TO REMOVE THE BALLOON FROM THE SHEATH, IT COULD NOT RETURN THROUGH THE 8 FR SHEATH. IT INSERTED INTO THE SHEATH WITH NO DIFFICULTY BUT IT WOULD NOT PULL BACK THROUGH THE 8FR SHEATH AFTER THE BALLOON HAD BEEN INFLATED. THE SHEATH HAD TO BE REMOVED FROM THE PATIENT AND A NEW 8FR SHEATH INSERTED BECAUSE THE BALLOON WOULD NOT EXIT THROUGH THE SHEATH. THE PATIENT HAD NO COMPLICATIONS, BUT THIS DID CAUSE UNNEEDED PROCEDURE COMPLICATIONS, INCREASED PROCEDURE TIME AND THE USE OF EXTRA SUPPLIES.
Patient problems: Insufficient Information; No Code Available
MAUDE report 8503379 ↗MalfunctionFeb 25, 2019Difficult to Remove; Difficult to Advance; Difficult to Remove
FOLLOW-UP REPORT TO SUBMIT ADDITIONAL INFORMATION NOT KNOWN AT TIME OF INITIAL SUBMISSION
Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient
MAUDE report 8365693 ↗
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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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