Dynamis AV D1604081475Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05391525783369), received between Jan 16, 2019 and May 26, 2021 — 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

Recent adverse event reports

The 3 most recent of 3 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: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11890670 ↗
• MalfunctionApr 11, 2019Difficult to Remove

  CUSTOMER REPORTS THAT 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 8FR 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. THE PATIENT DID HAVE A DVT POST PROCEDURE AND IS BEING TREATED FOR A DVT. IT IS ALSO REPORTED THAT NO PRODUCT WILL BE RETURNING.

  Patient problems: Insufficient Information; Thrombosis

  MAUDE report 8503381 ↗
• MalfunctionJan 16, 2019Difficult to Remove

  THE CUSTOMER REPORTED THAT THEY WERE NOT ABLE TO WITHDRAW THE BALLOONS THEY SHEATH. THEY REPORTED HAVING TO REMOVE THE SHEATH EACH TIME TO REMOVE THE BALLOON. THE CUSTOMER REPORTED THIS HAPPENING ON SEVERAL OCCASIONS.

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

  MAUDE report 8252095 ↗