Dynamis AV D1204071875Recalls & reported problems
Creagh Medical Limited · Dynamis PTA UHP 12mm 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
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 05391525783345), received between Jul 18, 2019 and Aug 14, 2020 — classified as 6 malfunctions.
The most frequently reported specific device problem is “Burst Container or Vessel” (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
- Burst Container or Vessel2
- Fluid/Blood Leak2
- Material Rupture2
- Material Separation2
- Accessory Incompatible1
- Difficult to Insert1
- Difficult to Remove1
- Failure to Deflate1
Patient problems
- No Clinical Signs, Symptoms or Conditions5
- No Known Impact Or Consequence To Patient4
- No Consequences Or Impact To Patient2
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 14, 2020Fluid/Blood Leak; Fluid/Blood Leak
PTA CASE IN WHICH THE PHYSICIAN USED THREE 12X4 FIRST CHOICE BALLOONS ALL OF WHICH EXPERIENCED ISSUES. ONE BURST, ONE LEAKED, AND ONE CAME APART WHERE IT CONNECTS TO THE SYRINGE. THIS REPORT FOCUSES ON THE LEAK DEVICE. ALL THREE DEVICES HAD THE SAME LOT NUMBER AND EXPIRATION DATE (LOT3 22001203, EXP- 6/2/23).
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10409465 ↗MalfunctionAug 14, 2020Fluid/Blood Leak; Leak/Splash; Material Separation; Fluid/Blood Leak; Leak/Splash; Material Separation
FOLLOW UP REPORT FOR CC2020-085-IR; MFR REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient
MAUDE report 10409457 ↗MalfunctionAug 14, 2020Material Separation; Material Separation
FOLLOW UP REPORT FOR (B)(6); MFR REPORT #: 3005994106-2020-00079.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient
MAUDE report 10409451 ↗MalfunctionApr 28, 2020Accessory Incompatible; Failure to Fold; Difficult to Insert; Difficult to Remove; Mechanical Jam; Failure to Deflate; Accessory Incompatible; Failure to Fold; Difficult to Insert; Difficult to Remove; Mechanical Jam; Failure to Deflate
FOLLOW UP REPORT FOR CC2020-046-IR; MFR REPORT #.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient
MAUDE report 10008108 ↗MalfunctionJul 18, 2019Material Rupture; Burst Container or Vessel; Material Rupture
THE CUSTOMER REPORTS DURING PROCEDURE UNDER NORMAL USAGE CONDITIONS THE BALLOON POPPED. NO PATIENT HARM WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient
MAUDE report 8803253 ↗MalfunctionJul 18, 2019Material Rupture; Burst Container or Vessel; Material Rupture
FOLLOW UP REPORT FOR (B)(6), MFR REPORT: 3005994106-2019-00007.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient
MAUDE report 8803241 ↗
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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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