Armada A2025-040Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 08717648156014), received between Feb 26, 2019 and Apr 11, 2026 — classified as 2 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (5 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 11, 2026Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 75% STENOSED DE NOVO LESION IN THE ANTERIOR TIBIAL ARTERY WITH MODERATE CALCIFICATION AND MODERATE TORTUOSITY. THE 2.5X40MM ARMADA 14 BALLOON DILATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION ON A COMMAND ES GUIDE WIRE (GW), AND THE BALLOON WAS INFLATED TO NOMINAL PRESSURE; HOWEVER, THE BALLOON THE BALLOON RUPTURED DURING THE FIRST INFLATION. THEREFORE, THE BDC REMOVED FROM THE PATIENT. A 2.5X60MM ARMADA 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 24852195 ↗
• MalfunctionDec 14, 2021Inflation Problem; Material Rupture; Inflation Problem; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE MODERATELY CALCIFIED AND MODERATELY TORTUOUS ANTERIOR TIBIAL ARTERY. THE 2.5X40 MM ARMADA 14 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER WAS ADVANCED ON A COMMAND GUIDE WIRE AND POSITIONED OVER THE LESION; HOWEVER, THE BALLOON WOULD NOT INFLATE AT ALL AND THERE WAS CONTRAST LEAKING FROM THE TIP OF THE BALLOON. INFLATION WAS ATTEMPTED TWICE, ONCE AT 8 ATMOSPHERES AND ONCE AT 10 ATMOSPHERES. THE ARMADA 14 PTA CATHETER WAS REMOVED AND A NON-ABBOTT BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13005574 ↗
• MalfunctionApr 27, 2020Difficult to Advance; Material Split, Cut or Torn; Difficult to Advance; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A PERIPHERAL PROCEDURE, PERFORMED TO TREAT A SEVERELY CALCIFIED LESION IN THE ANTERIOR TIBIAL ARTERY, THE ARMADA 14 DILATATION CATHETER AND THE HT WINN GUIDE WIRE WERE ADVANCED TOGETHER. DURING AN ATTEMPT TO CROSS TO THE TARGET LESION, IT WAS NOTED THAT THE TIP OF THE GUIDE WIRE WAS NOT EXITING THE BALLOON DILATATION CATHETER. BOTH DEVICES WERE REMOVED AS A SINGLE UNIT. IT WAS SUSPECTED THAT THE GUIDE WIRE MAY HAVE PERFORATED THE BALLOON AND WAS PREVENTED FROM EXITING. THERE WAS NO ADVERSE PATIENT EFFECT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10003542 ↗
• InjuryJan 30, 2020Material Rupture; Material Separation; Material Rupture; Material Separation

  USER FACILITY SUS VOLUNTARY EVENT REPORT RECEIVED THAT STATES: ON (B)(6) 2019, PATIENT PRESENTED TO THE PERIPHERAL VASCULAR LAB FOR REVASCULARIZATION OF HER RIGHT ANTERIOR TIBIAL ARTERY. A RIGHT LOWER EXTREMITY ANGIOGRAM SHOWED UP A PATENT COMMON FEMORAL DEEP FEMORAL ARTERY. THE SUPERFICIAL FEMORAL ARTERY WAS PATENT BUT DIFFUSELY DISEASED. THE POPLITEAL ARTERY WAS DIFFUSELY DISEASED. THE TIBIO PERSONAL TRUNK WAS PATENT BUT THE POSTERIOR TIBIAL AND PERENNIAL ARTERIES WERE DISEASED. RUNOFF NOTED VIA THE ANTERIOR TIBIAL ARTERY WHICH HAD A HIGH-GRADE STENOSIS PROXIMATELY. PER THE OPERATIVE NOTE, A GLIDEWIRE PASSED UP AND OVER BY A 6 FRENCH SHEATH. THE POPLITEAL ARTERY WAS ACCESSED AND THE GLIDEWIRE WAS PLACED INTO THE ANTERIOR TIBIAL ARTERY. THE WIRE WAS THEN EXCHANGED FOR A 14 WIRE. ANGIOPLASTY WAS THEN PERFORMED OF THE POPLITEAL AND PROVISIONAL FEMORAL ARTERY USING AN UNSPECIFIED 4X300MM BALLOON. REPEAT IMAGING SHOWED RESIDUAL STENOSIS IN THE PROXIMAL SUPERFICIAL ARTERY, AN UNSPECIFIED 6X100MM SELF-EXPANDING STENT WAS PLACED WHICH WAS POST DILATED INTO A 4MM. REPEAT ANGIOPLASTY WAS PERFORMED OF THE BELOW THE KNEE POPLITEAL ARTERY USING A 4X4MM ANGLO SCORE BALLOON. FOLLOWING THIS THE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9649593 ↗
• InjuryDec 17, 2019Entrapment of Device; Material Rupture

  ON (B)(6) 2019, PATIENT PRESENTED TO THE PERIPHERAL VASCULAR LAB FOR RE VASCULARIZATION OF HER RIGHT ANTERIOR TIBIAL ARTERY. A RIGHT LOWER EXTREMITY ANGIOGRAM SHOWED UP A PATENT COMMON FEMORAL DEEP FEMORAL ARTERY. THE SUPERFICIAL FEMORAL ARTERY WAS PATENT BUT DIFFUSELY DISEASED. THE POPLITEAL ARTERY WAS DIFFUSELY DISEASED. THE TIBIO PERSONAL TRUNK WAS PATENT BUT THE POSTERIOR TIBIAL AND PERENNIAL ARTERIES WERE DISEASED. RUNOFF NOTED VIA THE ANTERIOR TIBIAL ARTERY WHICH HAD A HIGH-GRADE STENOSIS PROXIMATELY. PER THE OPERATIVE NOTE, AN ADVANTAGE GLIDEWIRE PASSED UP AND OVER BY A 6 FRENCH SHEATH. THE POPLITEAL ARTERY WAS ACCESSED AND THE ADVANTAGE GLIDEWIRE WAS PLACED INTO THE ANTERIOR TIBIAL ARTERY. THE WIRE WAS THEN EXCHANGED OR V 14 WIRE. ANGIOPLASTY WAS THEN PERFORMED OF THE POPLITEAL AND PROVISIONAL FEMORAL ARTERY USING A 4X300 BALLOON. REPEAT IMAGING SHOW RESIDUAL STENOSIS IN THE PROXIMAL SUPERFICIAL ARTERY, A 6X100 SELF-EXPANDING STENT WAS PLACED WHICH WAS POST DILATED INTO A 4MM. REPEAT ANGIOPLASTY WAS PERFORMED OF THE BELOW THE KNEE POPLITEAL ARTERY USING A 4X4 ANGIO SCORE BALLOON. FOLLOWING THIS THE ORIGIN OF THE ANTERIOR TIBIAL ARTERY WAS ANGIO-PLASTIED USING A 2.5X4 CM BAL

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9489282 ↗
• MalfunctionNov 4, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN UNKNOWN LESION. THE ARMADA 2.5 X 40 MM WAS PREPPED WITHOUT ISSUE; HOWEVER, DURING USE, THE BALLOON RUPTURED AT 4 ATMOSPHERES. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT OR A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. A SECOND BALLOON WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION CAN OR WILL BE PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9276214 ↗
• MalfunctionFeb 26, 2019Leak/Splash; Material Split, Cut or Torn; Leak/Splash; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING PREPARATION AND BEFORE USE, THE ARMADA 14 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER WAS OBSERVED TO HAVE A HOLE IN THE BALLOON WHEN DRAWING NEGATIVE. THE DEVICE WAS NOT USED AND THERE WAS NO PATIENT INVOLVEMENT. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 8372075 ↗