Armada 1013465-200Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 08717648207938), received between Dec 22, 2016 and May 12, 2026 — classified as 15 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (12 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 12, 2026Material Rupture; Material Separation

  IT WAS REPORTED THAT DURING USE OF THE ARMADA 18 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER, THE BALLOON RUPTURED AND CAME APART. TREATMENT, IF ANY, WAS NOT SPECIFIED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 25150536 ↗
• MalfunctionMar 31, 2026Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE ANTERIOR TIBIAL ARTERY WITH MODERATE CALCIFICATION. THE 3X200 MM ARMADA 18 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER RUPTURED DURING THE FIRST INFLATION AT NOMINAL PRESSURE. ANOTHER SAME SIZE ARMADA PTA CATHETER WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24749626 ↗
• MalfunctionMar 19, 2026Material Split, Cut or Torn

  IT WAS REPORTED THAT THE ARMADA 18 WAS NOTED TO HAVE A HOLE IN THE BALLOON PORTION DURING PREP. IT NEVER ENTERED THE PATIENT. IT WAS DISCARDED AND A NEW BALLOON (ARMADA 018) WAS USED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24640058 ↗
• MalfunctionSep 13, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED SUPERFICIAL FEMORAL ARTERY THAT WAS 80% STENOSED. THE 3X200MM ARMADA 18 BALLOON WAS ADVANCED WITHOUT ISSUE TO THE LESION AND INFLATED ONCE AT 8 ATMOSPHERES WHEN IT RUPTURED. THE DEVICE WAS REMOVED. THEN A 4X200MM ARMADA 18 BALLOON WAS ADVANCED WITHOUT ISSUE TO THE LESION AND INFLATED ONCE AT 8 ATMOSPHERES WHEN IT RUPTURED. THE DEVICE WAS REMOVED. A ROTABLATOR WAS 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 15414367 ↗
• MalfunctionJun 22, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE RIGHT ANTERIOR TIBIAL (AT) TO POSTERIOR TIBIAL (PT) ARTERY WITH MODERATE TO HEAVY CALCIFICATION. THE 3.0X200MM ARMADA 18 BALLOON DILATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION; HOWEVER, THE BALLOON RUPTURED AFTER THE FIRST INFLATION AT 6 ATMOSPHERES (ATM). THE BDC WAS REMOVED WITHOUT ISSUE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED. A NON-ABBOTT GUIDEWIRE AND A NON-ABBOTT BALLOON WERE USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14781582 ↗
• MalfunctionOct 18, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE ANTERIOR TIBIAL ARTERY. A 3X200MM ARMADA 18 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER WAS ADVANCED WITHOUT RESISTANCE, AND THE BALLOON RUPTURED DURING THE FIRST INFLATION AT 2 ATMOSPHERES. THE DEVICE WAS REMOVED WITHOUT ISSUE, AND A SAME SIZED ARMADA 18 BALLOON WAS 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 12647959 ↗
• MalfunctionApr 9, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT MODERATELY TORTUOUS, HEAVILY CALCIFIED RIGHT ANTERIOR TIBIAL AND PART OF THE DISTAL POPLITEAL ARTERIES. ATHERECTOMY WAS PERFORMED PRIOR TO THE PROCEDURE STARTING. THEN AN ARMADA BALLOON WAS ADVANCED TO THE LESION WITHOUT ISSUE, INFLATED ONCE WHEN THE BALLOON RUPTURED AT 7 ATMOSPHERES (ATM). ANOTHER ARMADA WAS ADVANCED AND THE SAME ISSUE OCCURRED. THE DEVICES WERE RETRIEVED WITHOUT ISSUE. THE RIGHT ANTERIOR LESION WAS DEEMED GOOD, AND A 4X100MM ARMADA WAS USED TO SUCCESSFULLY FINISH THE DISTAL POPLITEAL LESION. 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 11645634 ↗
• MalfunctionApr 9, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY TORTUOUS, HEAVILY CALCIFIED RIGHT ANTERIOR TIBIAL AND PART OF THE DISTAL POPLITEAL ARTERIES. ATHERECTOMY WAS PERFORMED PRIOR TO THE PROCEDURE STARTING. THEN AN ARMADA BALLOON WAS ADVANCED TO THE LESION WITHOUT ISSUE, INFLATED ONCE WHEN THE BALLOON RUPTURED AT 7 ATMOSPHERES (ATM). ANOTHER ARMADA WAS ADVANCED AND THE SAME ISSUE OCCURRED. THE DEVICES WERE RETRIEVED WITHOUT ISSUE. THE RIGHT ANTERIOR LESION WAS DEEMED GOOD, AND A 4X100MM ARMADA WAS USED TO SUCCESSFULLY FINISH THE DISTAL POPLITEAL LESION. 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 11645584 ↗
• MalfunctionAug 6, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A NON-TORTUOUS, MODERATELY CALCIFIED ANTERIOR TIBIAL ARTERY. TWO ARMADA 18 BALLOONS (2.5X200MM AND 3X200MM) WERE SEPARATELY ADVANCED TO THE LESION AND INFLATED ONCE AT 8 ATMOSPHERES AND RUPTURED. THE DEVICES WERE REMOVED AND CASE WAS ABORTED. 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 10376192 ↗
• MalfunctionNov 21, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN UNSPECIFIED ARTERY. A 3.0X200MM ARMADA 18 BALLOON DILATATION CATHETER RUPTURED DURING THE PROCEDURE. ANOTHER ARMADA BALLOON WAS 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 9354413 ↗
• MalfunctionOct 15, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE ARMADA DILATATION CATHETER BALLOON BURST AT A LOW PRESSURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9194320 ↗
• MalfunctionApr 9, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY TORTUOUS, HEAVILY CALCIFIED ANTERIOR TIBIAL LESION. AFTER A NON-ABBOTT ATHERECTOMY DEVICE WAS USED, A 3.0X200MM ARMADA 18 BALLOON DILATION CATHETER (BDC) WAS USED; HOWEVER, IT RUPTURED DURING THE FIRST INFLATION AT 4 ATMOSPHERES. A NEW SAME SIZE ARMADA BDC WAS 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 8495691 ↗
• MalfunctionMar 7, 2018Material Rupture

  IT WAS REPORTED THAT DURING A PERIPHERAL PROCEDURE, THE 3.0 X 200 MM ARMADA 18 DILATATION CATHETER WAS ADVANCED TO THE TARGET LESION IN THE MILDLY CALCIFIED ANTERIOR TIBIAL ARTERY. THE ARMADA 18 BALLOON WAS INFLATED TO 8 ATMOSPHERES AND RUPTURED DURING THE FIRST INFLATION. THE DEVICE WAS REMOVED WITHOUT DIFFICULTY. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7322453 ↗
• MalfunctionFeb 22, 2018Break; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A NON-TORTUOUS, MODERATELY CALCIFIED ANTERIOR TIBIAL ARTERY. A 3.0 X 200MM ARMADA 18 BALLOON DILATATION CATHETER (BDC) WAS INFLATED ONCE AT 8 ATMOSPHERES. RESISTANCE WAS MET DURING REMOVAL. ONCE REMOVED IT WAS NOTED THAT PART OF THE BALLOON WAS DANGLING OFF THE DISTAL SHAFT, BUT STILL ATTACHED. ANOTHER SAME SIZE ARMADA 18 BDC WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. 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 7289033 ↗
• MalfunctionDec 22, 2016Leak/Splash

  IT WAS REPORTED THAT AFTER UNEVENTFUL DEVICE PREPARATION FOR A PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY (SFA) WITH MILD CALCIFICATION, THE ARMADA BALLOON LEAKED AT THE HUB DURING INFLATION AT NOMINAL PRESSURE. THE BALLOON WAS SUCCESSFULLY INFLATED AND USED IN THE PROCEDURE WITHOUT ADVERSE PATIENT EFFECT. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6201113 ↗