Armada A2030-020Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08717648156069), received between Feb 14, 2017 and Oct 24, 2019 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (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 18, 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.

• MalfunctionOct 24, 2019Difficult to Remove; Material Rupture; Material Separation; Improper or Incorrect Procedure or Method; Difficult to Remove; Material Rupture; Material Separation; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A TIGHT (NAPKIN RING) LESION IN THE LEFT SUPERFICIAL FEMORAL ARTERY OSTIAL COLLATERAL ARTERY. THE ARMADA DILATATION CATHETER WAS ADVANCED TO THE TARGET LESION AND INFLATED TO 26 ATMOSPHERES (ATM), ABOVE RATED BURST PRESSURE (RBP). A BALLOON RUPTURE OCCURRED; HOWEVER, THERE WAS NO ADVERSE PATIENT EFFECT. THE DEVICE WAS REMOVED AND RESISTANCE WAS NOTED. DURING REMOVAL FROM THE ANATOMY, IT WAS NOTED THAT A DEVICE SEPARATION OCCURRED, WITH THE INNER MEMBER SEPARATING FROM THE DEVICE. THE POINT OF SEPARATION WAS INSIDE THE ANATOMY, BUT REMAINED ON THE GUIDE WIRE AND WAS COMPLETELY AND EASILY REMOVED. THERE WAS NO ADVERSE PATIENT EFFECT OR A CLINICALLY SIGNIFICANT DELAY IN PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9235141 ↗
• MalfunctionMar 2, 2017Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE PERONEAL ARTERY. A 3.0X20MM ARMADA 14 BALLOON DILATATION CATHETER (BDC) WAS PREPPED PER THE INSTRUCTIONS FOR USE. THE BDC WAS ADVANCED TO THE LESION; HOWEVER, THE BALLOON RUPTURED DURING FIRST INFLATION AT 4 ATMOSPHERES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A NEW 3.0X20MM ARMADA 14 BDC. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6373496 ↗
• MalfunctionFeb 14, 2017Inflation Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A PERIPHERAL ARTERY PROCEDURE. THE 3.0 X 60 MM ARMADA 14 AND THE 3.0 X 20 MM ARMADA 14 DILATATION CATHETERS WERE EACH ADVANCED TO THE TARGET LESION IN THE ANTERIOR TIBIAL ARTERY, WITHOUT DIFFICULTY. ATTEMPTS WERE MADE TO INFLATE THE BALLOONS; HOWEVER, FOR EACH DEVICE, THE BALLOON WOULD NOT INFLATE. THERE WAS NO ADVERSE PATIENT EFFECT. THE DEVICES WERE ABLE TO BE REMOVED FROM THE PATIENT ANATOMY WITHOUT DIFFICULTY AND THE TARGET LESION WAS TREATED WITH AN ADDITIONAL DEVICE. THE 4.0 X 20 MM ARMADA 14 DILATATION CATHETER WAS ADVANCED TO THE TARGET LESION IN THE HEAVILY CALCIFIED SUPERFICIAL FEMORAL ARTERY (SFA); HOWEVER, DURING THE SECOND INFLATION, THE BALLOON RUPTURED AT 8 ATMOSPHERES (ATM). THE DEVICE WAS REMOVED WITHOUT ISSUE AND THERE WAS NO ADVERSE PATIENT EFFECT. A SECOND DEVICE WAS USED SUCCESSFULLY TO COMPLETE DILATATION OF THE SFA. THERE WAS NO ADDITIONAL INFORMATION PROVIDED REGARDING THE ABOVE MENTIONED DEVICES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6330969 ↗