Armada 1013465-080Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08717648207884), received between May 6, 2020 and Jul 12, 2023 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 12, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE RIGHT SUPERFICIAL FEMORAL ARTERY (SFA) WITH CALCIFICATION AND 70% STENOSIS. THE 3.0X80 MM ARMADA 18 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER RUPTURED ON THE FIRST INFLATION TO RATED BURST PRESSURE. ANOTHER UNSPECIFIED BALLOON 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 17308196 ↗
• MalfunctionJun 22, 2023Break; Difficult to Insert; Difficult to Advance; Break; Difficult to Insert; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED, MODERATELY STENOSED LESION IN THE RIGHT ANTERIOR TIBIAL ARTERY. DURING THE PROCEDURE THE 3.0X80MM ARMADA 18 BALLOON DILATATION CATHETER (BDC) WAS ADVANCED AND USED WITHOUT ISSUE. THE BDC WAS THEN REMOVED FROM THE ANATOMY WITHOUT ISSUE. THE PHYSICIAN ATTEMPTED TO RE-INSERT THE BDC A SECOND TIME OVER THE GUIDE WIRE (GW), BUT HAD DIFFICULTY LOADING THE BALLOON ONTO THE WIRE, THEN THE BDC BECAME STUCK ABOUT HALFWAY ON THE WIRE AND HE COULD NOT BE RE-ADVANCED INTO THE ANATOMY. THE BDC WAS REPLACED BY A NEW, SAME SIZE ARMADA 18 TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAYS IN THE PROCEDURE. RETURNED DEVICE ANALYSIS FOUND THAT THERE WAS A MARKER SEPARATION OF THE RETURNED DEVICE. THE ACCOUNT CANNOT CONFIRM ANY DETAILS AS THEY CAN¿T RECALL AND ARE UNSURE OF THE MARKER SEPARATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17187494 ↗
• MalfunctionMay 18, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED, 75% STENOSED LESION IN THE TIBIAL ARTERY. A 3.0MMX80MM/150CM ARMADA 18 BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE LESION WITHOUT ISSUE AND INFLATED ONE TIME TO 8 ATMOSPHERES (ATM) WHEN THE BALLOON RUPTURED. THE BDC WAS REMOVED, AND A 2.5 ABBOTT BALLOON 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 16955457 ↗
• MalfunctionJun 15, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE HEAVILY CALCIFIED, NON-TORTUOUS, 70% STENOSED SUPERFICIAL FEMORAL ARTERY. A 6X200MM, 3X80MM, & 5.5X200MM ARMADA 18 AS WELL AS A 3X40MM & 4X60MM PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON CATHETERS (PTA) WERE ALL ADVANCED, AND THE BALLOONS RUPTURED AT 14 ATMOSPHERES IN THAT ORDER. A NON-ABBOTT BALLOON AND TWO UNSPECIFIED STENTS WERE USED TO SUCCESSFULLY 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 Consequences Or Impact To Patient

  MAUDE report 10153978 ↗
• MalfunctionMay 6, 2020Leak/Splash; Material Rupture; Leak/Splash; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE MODERATELY CALCIFIED AND TORTUOUS POSTERIOR TIBIAL ARTERY. THE ARMADA 18 WAS ADVANCED INTO THE PATIENT ANATOMY. SOME RESISTANCE WAS NOTED DUE TO THE PATIENT ANATOMY, BUT THE DEVICE WAS ABLE TO ADVANCE TO THE TARGET LESION. DURING THE FIRST INFLATION, THE BALLOON WAS INFLATED TO 8 ATMOSPHERES (ATM) AND LEAKING WAS NOTED AT THE BALLOON. BALLOON RUPTURE WAS SUSPECTED AND THE DEVICE WAS REMOVED WITHOUT RESISTANCE. A SECOND SAME DEVICE WAS THEN USED WITHOUT ISSUE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10029135 ↗