Armada B2060-080Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 08717648155284), received between Sep 6, 2017 and Mar 19, 2026 — classified as 1 injury, 10 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (7 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.

• MalfunctionMar 19, 2026Material Split, Cut or Torn

  IT WAS REPORTED THAT THE ARMADA 35 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 35) WAS USED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24639934 ↗
• MalfunctionMar 17, 2026Leak/Splash

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A DE NOVO, MODERATELY CALCIFIED, MODERATELY TORTUOUS SUPERFICIAL FEMORAL ARTERY THAT IS 75% STENOSED. THE 6X80MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE LESION AND INFLATED TO NOMINAL PRESSURE. THE BALLOON WAS LOSING PRESSURE WHEN TRYING TO INFLATE AND ONLY PARTIALLY INFLATED WHEN LEAKING WAS FOUND AT THE HUB. A NEW 6X100MM ARMADA BDC 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 24621549 ↗
• MalfunctionSep 18, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN SUPERFICIAL FEMORAL ARTERY (SFA). TWO 6X200MM ARMADA BALLOON DILATATION CATHETERS (BDC) AND ONE 6X80 ARMADA BDC WERE ADVANCE TO THE TARGET LESION AND ALL THREE BALLOONS RUPTURED AT 6 ATMOSPHERES (ATM) DURING THE FIRST INFLATION. AN UNSPECIFIED 6X80MM BDC WAS USED TO CONTINUE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23085923 ↗
• MalfunctionFeb 28, 2024Difficult to Remove; Material Rupture; Difficult to Remove; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE MID RIGHT SUPERFICIAL FEMORAL ARTERY (SFA) WITH 80-90% STENOSIS, MODERATE CALCIFICATION AND NO TORTUOSITY. THE 6.0X80MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) WAS ADVANCED WITHOUT RESISTANCE BUT RUPTURED DURING THE FIRST INFLATION AT RATED BURST PRESSURE (RBP). ATTEMPTED TO REMOVE THE BALLOON THROUGH THE SHEATH BUT WOULD NOT PASS THROUGH THE SHEATH. THE SHEATH WAS REMOVED FROM THE PATIENT'S GROIN AND THE BALLOON HAD TO BE CUT OFF OF THE BDC SO THE BALLOON CATHETER COULD BE PULLED OUT OF THE SHEATH. THE SHEATH WAS THEN PUT BACK IN THE PATIENT'S GROIN AND THE PROCEDURE CONTINUED. NOTHING REMAINS IN THE PATIENT AND EVERY PIECE OF THE ARMADA BDC WAS REMOVED. ANOTHER BDC WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT 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 18798756 ↗
• MalfunctionAug 28, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA) WITH MODERATE CALCIFICATION. THE 6.0X80MM ARMADA 35 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER WAS INFLATED TWICE AND A RUPTURE OCCURRED AT 12 ATMOSPHERES. ANOTHER 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 17633660 ↗
• MalfunctionAug 23, 2023Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED, MILDLY TORTUOUS, 98% STENOSED LESION IN THE DISTAL SUPERFICIAL FEMORAL ARTERY (DSFA). AFTER LEFT GROIN ACCESS WAS OBTAINED, TWO NON-ABBOTT BALLOONS WERE ADVANCED AND BOTH RUPTURED, SO IT WAS DECIDED TO SWITCH TO ABBOTT DEVICES. A 6MMX80MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) WAS ADVANCED. RESISTANCE WAS NOTED WITH THE ANATOMY. THE BDC REACHED THE LESION AND WAS INFLATED ONE TIME TO NOMINAL PRESSURE WHEN THE BALLOON RUPTURED. THE BDC WAS REMOVED WITHOUT ISSUE. A 6.0MMX100MMX150CM ARMADA 18 BDC WAS THEN ADVANCED WITHOUT RESISTANCE. THE BDC MADE IT TO THE TARGET LESION AND WAS INFLATED ONE TIME TO 10 ATMOSPHERES (ATM), BUT THE BALLOON RUPTURED. THE BDC WAS REMOVED WITHOUT ANY ISSUES. ANOTHER SAME SIZED ARMADA 18 BDC WAS ADVANCED WITHOUT ISSUE AND WAS USED TO SUCCESSFULLY COMPLETED DILATATION. 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 17607789 ↗
• MalfunctionJul 24, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE 6.0X80 MM ARMADA 35 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER RUPTURED. ANOTHER ABBOTT BALLOON 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 17381774 ↗
• MalfunctionApr 17, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE HEAVILY CALCIFIED LEFT SUPERFICIAL FEMORAL ARTERY. THE 6 X 80 MM ARMADA 35 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER WAS ADVANCED TO THE TARGET LESION WITHOUT RESISTANCE, BUT DURING THE FIRST INFLATION, THE BALLOON RUPTURED AT 2 ATMOSPHERES. THE PROCEDURE WAS COMPLETED USING ANOTHER UNSPECIFIED ARMADA 35 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 8524898 ↗
• InjurySep 28, 2018Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE PROXIMAL RIGHT SUPERFICIAL FEMORAL ARTERY WITH A 99% SUBTOTAL OCCLUSION IN THE PROXIMAL RIGHT SUPERFICIAL FEMORAL ARTERY. A 5.0X100MM SELF EXPANDING STENT WAS IMPLANTED. A 6.0X80 MM ARMADA 35 WAS INFLATED ONE TIME TO NOMINAL PRESSURE TO POST DILATE. AFTER THE FIRST INFLATION, THE ARMADA WAS UNABLE TO BE DEFLATED. AFTER MULTIPLE ATTEMPTS WERE MADE TO DEFLATE THE ARMADA 35, IT WAS INFLATED TO RATED BURST PRESSURE, BUT THAT DID NOT RESOLVE THE DEFLATION ISSUE. WITH ULTRASOUND GUIDANCE, A NEEDLE WAS INSERTED AND SUCCESSFULLY PUNCTURED THE ARMADA 35 BALLOON. THE DEFLATED ARMADA 35 WAS REMOVED FROM THE ANATOMY. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7918957 ↗
• MalfunctionDec 21, 2017Insufficient Device Problem Information

  IT WAS REPORTED THAT THERE WAS NO INFORMATION ON THIS COMPLAINT. NO ADDITIONAL INFORMATION WAS PROVIDED. ANALYSIS OF THE RETURNED DEVICE IDENTIFIED A PINHOLE RUPTURE IN THE MIDDLE OF THE BALLOON.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7138037 ↗
• MalfunctionSep 6, 2017Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN 80% STENOSIS IN A HEAVILY CALCIFIED SUPERFICIAL FEMORAL ARTERY (SFA) AND A 90% STENOSIS IN A HEAVILY CALCIFIED COMMON ILIAC ARTERY. A 6 X 80 MM ARMADA 35 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER WAS SELECTED FOR PRE-DILATATION OF THE LESION IN THE SFA. THE PTA CATHETER WAS ADVANCED TO THE LESION AND WHEN INFLATED TO 10 ATMOSPHERES (ATM) THE BALLOON RUPTURED. A NEW 7 X 80 MM ARMADA 35 PTA CATHETER WAS USED TO COMPLETE THE PRE-DILATATION AND AN UNSPECIFIED STENT IMPLANT WAS SUCCESSFULLY DEPLOYED. FOLLOWING DEPLOYMENT OF AN UNSPECIFIED STENT IMPLANT IN THE COMMON ILIAC ARTERY, A 10 X 20 MM ARMADA 35 PTA CATHETER WAS SELECTED FOR POST- DILATATION. WHEN INFLATED TO 13 ATM THE BALLOON RUPTURED AND WAS REPLACED WITH A 12 X 20 MM ARMADA 35 PTA CATHETER. WHEN INFLATED TO 10 ATM THE BALLOON RUPTURED. AS THERE WAS SUFFICIENT WALL APPOSITION ADDITIONAL POST-DILATATION WAS NOT NECESSARY. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6846255 ↗