Armada A2040-080Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08717648156151), received between May 10, 2023 and Oct 27, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Deflation Problem” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 27, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE LEFT POPLITEAL ARTERY WITH MILD CALCIFICATION AND NO TORTUOSITY. THE 4X80 MM ARMADA PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER WAS INFLATED ONCE AND RUPTURED AT NOMINAL PRESSURE 8 ATMOSPHERES. AN ARMADA 35 WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23393474 ↗
• MalfunctionAug 28, 2023Deflation Problem; Difficult to Remove; Improper or Incorrect Procedure or Method; Deflation Problem; Difficult to Remove; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE RIGHT ANTERIOR TIBIAL ARTERY WITH MILD CALCIFICATION AND A CONTRAST MIX OF 50% SALINE AND 50% CONTRAST. THE 3.0X120MM ARMADA 14 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) WAS INFLATED ONCE AND A RUPTURE OCCURRED AT 4 ATMOSPHERES. IT IS POSSIBLE THAT A PIECE OF THE BALLOON MAY HAVE REMAINED IN THE INDEFLATOR; HOWEVER, IT WAS CONFIRMED THAT NOTHING REMAINED IN THE PATIENT. ANOTHER 4.0X80MM ARMADA 14 PTA WAS INFLATED ONCE AT 18 ATMOSPHERES; HOWEVER, DESPITE THE BALLOON WAS IN NEGATIVE HELD FOR TWENTY SECONDS, COULD NOT BE DEFLATED. A NON-ABBOTT INDEFLATOR WAS USED, BUT THE ISSUE PERSISTED AND WAS REMOVED PARTIALLY DEFLATED BUT AS A SINGLE UNIT. THERE WAS RESISTANCE DURING REMOVAL WITH EITHER THE PIECE OF BALLOON OR THE CATHETER. ANOTHER ARMADA 14 WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17633759 ↗
• MalfunctionJun 22, 2023Deflation Problem; Difficult to Remove; Deflation Problem; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY CALCIFIED, MILDLY TORTUOUS LESION IN THE COMMON FEMORAL ARTERY (CFA). AN HT COMMAND 14 GUIDE WIRE (GW) WAS ADVANCED TO THE LESION WITHOUT RESISTANCE, AND A 4.0MMX80MMX150CM ARMADA 14 BALLOON DILATATION CATHETER (BDC) WAS ADVANCED OVER THE GW WITHOUT RESISTANCE AND INFLATED WITHOUT ISSUE. DURING AN ATTEMPT TO DEFLATE THE ARMADA BALLOON, DEFLATION WAS DIFFICULT, NEGATIVE WAS HELD FOR APPROXIMATELY 30 SECONDS AND THE BALLOON ONLY PARTIALLY DEFLATED AFTER MULTIPLE ATTEMPTS. AN ATTEMPT WAS MADE TO REMOVE THE BDC FROM THE ANATOMY, HOWEVER THE BDC BECAME STUCK ON THE COMMAND GW AND BOTH DEVICES HAD TO BE REMOVED AS A SINGLE UNIT. A NEW GUIDE WIRE AND BALLOON DILATATION CATHETER WERE USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAYS IN THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17186568 ↗
• MalfunctionMay 10, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED, MILDLY TORTUOUS, 70% STENOSED LESION IN THE POPLITEAL ARTERY. A 4.0X80MM ARMADA 14 BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION AND INFLATED ONE TIME TO UNSPECIFIED PRESSURE, WHEN A LEAK WAS NOTED FROM THE HUB OF THE BDC. THE BDC WAS REMOVED AND A 4.0X200MM ARMADA 14 BDC WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAYS IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16903817 ↗