Armada 1013468-150Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 08717648208225), received between May 17, 2018 and Apr 24, 2026 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (8 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 24, 2026Leak/Splash

  IT WAS REPORTED THAT DURING PREPARATION OF THE 5X150MM ARMADA 18 BALLOON DILATION CATHETER (BDC), A BALLOON LEAK WAS NOTED. THEREFORE, THE BDC WAS NOT USED IN THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24975443 ↗
• MalfunctionNov 18, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT IN-STENT RESTENOSIS IN THE LEFT SUPERFICIAL FEMORAL ARTERY (SFA). THE 5.0X150MM ARMADA 18 BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION; HOWEVER, WHEN INFLATED, THE BALLOON RUPTURED AT 5 ATMOSPHERES (ATM). THE BDC WAS REMOVED AND A 5.0X120MM ARMADA 18 WAS ADVANCED HOWEVER THE SAME ISSUE OCCURRED. A THIRD DEVICE, A 5.0X40MM ARMADA 35 WAS USED; HOWEVER AGAIN THE BALLOON RUPTURED AT 5 ATM. THE PROCEDURE WAS COMPLETED USING A NON-ABBOTT DEVICE. 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 23580865 ↗
• MalfunctionAug 25, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A LESION IN THE HEAVILY CALCIFIED PROXIMAL LEFT SUPERFICIAL FEMORAL ARTERY. THE 5.0X120MM, 5.0X150MM ARMADA 35 BALLOON DILATATION CATHETERS RUPTURED DURING THE FIRST INFLATION AT 8 ATMOSPHERES (ATM). A 7.0X100MM ABSOLUTE PRO STENT WAS THEN DEPLOYED IN THE TARGET LESION. A 6.0X40MM ARMADA 35 WAS USED TO POST DILATE THE STENT HOWEVER ALSO RUPTURED DURING THE FIRST INFLATION AT 10 ATM. 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 22883894 ↗
• MalfunctionJan 7, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A LESION IN THE SUPERFICIAL FEMORAL ARTERY. THE 5.0X150MM ARMADA 18 BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION AND INFLATED TO NOMINAL PRESSURE (8 ATMOSPHERES) WHEN IT WAS NOTED THE PRESSURE STARTED TO DECREASE. A LEAK WAS NOTED AT THE PROXIMAL END OF THE HUB. THE INFLATION DEVICE WAS CONTINUALLY INCREASED IN ORDER TO INFLATE THE BALLOON AND THE LESION SUFFICIENTLY DILATED. 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 21092138 ↗
• MalfunctionOct 7, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A MODERATELY CALCIFIED LESION IN THE DISTAL SUPERFICIAL FEMORAL ARTERY (SFA) AND PROXIMAL POPLITEAL ARTERY. LESION DILATION WAS ATTEMPTED USING A 5.0X150MM ARMADA 18 BALLOON DILATATION CATHETER (BDC); HOWEVER, THE BDC WAS NOTED TO RUPTURE WHEN INFLATED TO 8 ATMOSPHERES. THE BDC WAS REMOVED AND A TOTAL OF FOUR ARMADA 35¿S, SIZED AT 5X80MM, 6X100MM, AND 6X150MM (2 DEVICES), WERE USED FOR DILATATION HOWEVER IT WAS NOTED THAT EACH REPLACEMENT BDC WERE INITIALLY INFLATED AND REMOVED SUCCESSFULLY, BUT COULD NOT BE REINSERTED INTO THE INTRODUCER SHEATH FOR RE-DILATATION. ANOTHER ABBOTT BALLOON AND STENT WERE 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 20384320 ↗
• MalfunctionSep 5, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A HEAVILY CALCIFIED LESION IN THE LEFT EXTERNAL ILIAC ARTERY WITH A 5X150MM ARMADA 18 BALLOON PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER WHICH WAS PREPPED PER IFU. THE ARMADA 18 BALLOON WAS ADVANCED AND A RUPTURE OCCURRED AT NOMINAL PRESSURE. ORBITAL ATHERECTOMY WAS PERFORMED. A SECOND 5X150MM ARMADA 18 BALLOON PTA WAS ADVANCED AND A RUPTURE OCCURRED AT NOMINAL PRESSURE, WHICH WAS RELATED TO THE SIGNIFICANT CALCIFICATION. ANOTHER UNSPECIFIED SAME SIZE BALLOON WAS THEN USED IN 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 20149374 ↗
• MalfunctionSep 5, 2024Material Rupture; Material Rupture

  N/A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20149191 ↗
• MalfunctionJun 3, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A RESTENOSED HEAVILY CALCIFIED LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA). THE 5.0X150MM ARMADA 18 BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE LESION AND INFLATED ONE TIME TO 6 ATMOSPHERES (ATM) WHEN THE BALLOON RUPTURED. THE DEVICE WAS REMOVED WITHOUT ISSUE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT EFFECT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A SAME SIZE ARMADA 18 BDC. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14598229 ↗
• MalfunctionMar 2, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A LESION WITH MODERATE CALCIFICATION IN THE SUPERFICIAL FEMORAL ARTERY (SFA). THE 5.0 X 150 MM ARMADA 18 BALLOON CATHETER WAS ADVANCED WITHOUT RESISTANCE TO THE TARGET LESION; HOWEVER, DURING THE FIRST INFLATION THE BALLOON RUPTURED AT 6 ATMOSPHERES. A NEW BALLOON CATHETER WAS USED SUCCESSFULLY IN THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11399972 ↗
• MalfunctionFeb 27, 2019Inflation Problem; Leak/Splash; Inflation Problem; Leak/Splash

  IT WAS REPORTED THAT DURING A PROCEDURE OF THE CHRONIC, TOTALLY OCCLUDED, LEFT SUPERFICIAL FEMORAL ARTERY (SFA), THE 5.0 X 15 MM ARMADA 0.018 BALLOON DILATATION CATHETER (BDC) WAS INSERTED AND DURING INFLATION LEAKED AT THE HUB AND WOULD NOT HOLD PRESSURE. THERE WAS NO REPORTED 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 8376078 ↗
• MalfunctionMay 17, 2018Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE SUPERFICIAL FEMORAL ARTERY. AFTER ADVANCEMENT OF THE 5.0 X 150 MM ARMADA 18 BALLOON CATHETER TO THE LESION, THE BALLOON WAS INFLATED TO NOMINAL PRESSURE; HOWEVER, WAS NOT ABLE TO MAINTAIN PRESSURE. A BALLOON RUPTURE WAS SUSPECTED. THERE WAS NO RESISTANCE FELT DURING ADVANCEMENT OF THE BALLOON CATHETER TO THE LESION. THERE WERE NO ISSUES NOTED DURING PREPARATION OF THE DEVICE. NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7522241 ↗