Dynamis AVRecalls & reported problems across all models
Creagh Medical Limited · 8 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 20
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 0
We found 8 models of Dynamis AV by Creagh Medical Limited in the FDA's device registry (GUDID). Together they are named in 20 adverse event reports in the FDA's MAUDE database, received between Jan 16, 2019 and May 26, 2021 — classified as 20 malfunctions.
The most frequently reported specific device problem is “Mechanical Jam” (7 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Most reported Dynamis AV problems
Device problems
- Mechanical Jam7
- Difficult to Remove6
- Failure to Deflate5
- Failure to Fold5
- Material Rupture5
- Accessory Incompatible4
- Difficult to Open or Close4
- Burst Container or Vessel2
Patient problems
- No Clinical Signs, Symptoms or Conditions13
- No Known Impact Or Consequence To Patient8
- Insufficient Information7
- No Consequences Or Impact To Patient4
- Foreign Body In Patient2
- No Code Available1
- No Information1
- Physical Entrapment1
Dynamis AV models
8 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Dynamis AV D1204071875Catheter, Angioplasty, Peripheral, Transluminal6 reports
- Dynamis AV D1404081675Catheter, Angioplasty, Peripheral, Transluminal4 reports
- Dynamis AV D1004072075Catheter, Angioplasty, Peripheral, Transluminal3 reports
- Dynamis AV D1604081475Catheter, Angioplasty, Peripheral, Transluminal3 reports
- Dynamis AV D0604062575Catheter, Angioplasty, Peripheral, Transluminal1 report
- Dynamis AV D0804062475Catheter, Angioplasty, Peripheral, Transluminal1 report
- Dynamis AV D0808062275Catheter, Angioplasty, Peripheral, Transluminal1 report
- Dynamis AV D0904072075Catheter, Angioplasty, Peripheral, Transluminal1 report
Recent Dynamis AV adverse event reports
The 15 most recent reports across all models, 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 ↗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 11890670 ↗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 ↗MalfunctionJun 29, 2020Material Rupture; Structural Problem; Detachment of Device or Device Component; Material Rupture; Structural Problem; Detachment of Device or Device Component
FOLLOW UP REPORT FOR CC2020-066-IR; MFR REPORT#: 3005994106-2020-00066.
Patient problems: Foreign Body In Patient; No Consequences Or Impact To Patient
MAUDE report 10208556 ↗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 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 ↗MalfunctionNov 20, 2019Retraction Problem; Mechanical Jam; Retraction Problem; Material Rupture; Mechanical Jam
FOLLOW UP REPORT FOR (B)(6), MFR. REPORT #: 3005994106-2019-00010.
Patient problems: Foreign Body In Patient; Physical Entrapment
MAUDE report 9346031 ↗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 ↗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 ↗MalfunctionApr 17, 2019Material Puncture/Hole; Material Rupture
CUSTOMER HAS REPORTED THAT DURING PROCEDURE THE BALLOON POPPED WHEN THEY TOOK IT OUT THERE WAS A PIN HOLE IN IT.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Information
MAUDE report 8522131 ↗
Other Creagh Medical Limited products
All Creagh Medical Limited devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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