Armada A2030-060Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 08717648156083), received between Feb 14, 2017 and Aug 18, 2026 — classified as 1 injury, 13 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (11 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 18, 2026Material Rupture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50303200 ↗
• MalfunctionNov 25, 2023Failure to Fold; Material Twisted/Bent; Material Split, Cut or Torn; Failure to Fold; Material Twisted/Bent; Material Split, Cut or Torn

  IT WAS REPORTED THAT PRIOR TO INSERTING THE 3.0X60MM ARMADA 14 BALLOON DILATATION CATHETER (BDC) INTO THE SHEATH, SOME BUNCHING AND A TEAR AT THE PROXIMAL END OF THE CATHETER WAS NOTED. ANOTHER ARMADA 14 BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DEVICE USE OR PATIENT INVOLVEMENT. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18207627 ↗
• MalfunctionJul 20, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE 3.0X60 MM ARMADA PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER RUPTURED. ANOTHER ABBOTT BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED 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 17367360 ↗
• MalfunctionMar 22, 2023Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED RIGHT ANTERIOR TIBIAL ARTERY. THE 3.0X60MM ARMADA 14 BALLOON DILATATION CATHETER WAS ADVANCED BUT MET RESISTANCE WITH ANATOMY. ONCE AT THE LESION, THE BALLOON WAS INFLATED BUT RUPTURED AT 10 ATMOSPHERES. ANOTHER UNSPECIFIED BALLOON WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS 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 16594586 ↗
• MalfunctionJun 11, 2021Inflation Problem; Material Rupture; Inflation Problem; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION WITH SEVERE CALCIFICATION AND MILD TORTUOSITY IN THE LEFT ANTERIOR TIBIAL ARTERY. THE 3.0 X 60 MM ARMADA 14 BALLOON CATHETER CROSSED THE LESION; HOWEVER, DURING AN ATTEMPT TO INFLATE THE BALLOON TO NOMINAL PRESSURE, THE PRESSURE DID NOT INCREASE. THEREFORE, THE BALLOON CATHETER WAS REMOVED WITHOUT ISSUE. A NEW ARMADA 14 BALLOON WAS USED SUCCESSFULLY. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THE RETURNED DEVICE ANALYSIS IDENTIFIED A PINHOLE IN THE BALLOON MATERIAL 2.7CM DISTAL TO THE PROXIMAL MARKER. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11986313 ↗
• InjuryJul 6, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT LESIONS IN THE RIGHT SUPERFICIAL FEMORAL ARTERY (SFA), POPLITEAL ARTERY, RIGHT POSTERIOR TIBIAL ARTERY AND RIGHT PERONEAL ARTERY. AFTER SUCCESSFUL ATHERECTOMY AND STENT IMPLANTATION IN THE PROXIMAL POPLITEAL ARTERY TO PROXIMAL SFA, ATHERECTOMY WAS PERFORMED IN THE DISTAL PERONEAL ARTERY, FOLLOWED BY ANGIOPLASTY USING A 3.0 X 60 ARMADA BALLOON. AT AN UNSPECIFIED PRESSURE, THE BALLOON RUPTURED. ANGIOGRAPHY NOTED A MICROPERFORATION OF THE VESSEL, WITH SMALL CONTRAST EXTRAVASATION. PROLONGED BALLOON INFLATION WAS PERFORMED; HOWEVER, THE PERFORATION PERSISTED SO A 4.0 X 19 MM GRAFTMASTER STENT WAS IMPLANTED, SUCCESSFULLY RESOLVING THE PERFORATION. THE PROCEDURE WAS COMPLETED WITH INTERVENTION TO THE POSTERIOR TIBIAL ARTERY. FINAL ANGIOGRAPHY NOTED NO DISSECTION, PERFORATION OR THROMBUS PRESENT AND TIMI 3 FLOW. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Perforation

  MAUDE report 10237611 ↗
• MalfunctionJul 1, 2020Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT RESISTANCE WAS FELT WHEN ADVANCING THE 3.0X60MM ARMADA 14 BALLOON CATHETER DUE TO CALCIFICATION. ONCE AT THE TARGET LESION, THE BALLOON RUPTURED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A 3.0X80MM ARMADA BALLOON CATHETER. 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 10220327 ↗
• MalfunctionDec 12, 2019Material Rupture; Failure to Advance; Material Rupture; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE LEFT ANTERIOR TIBIAL ARTERY AND ANOTHER DISTAL LESION IN THE SUPERFICIAL FEMORAL ARTERY. A 3X60MM ARMADA 14 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER FAILED TO CROSS THE INTENDED DISTAL LESION DUE TO THE ANATOMY, SO THE PROXIMAL LESION WAS TREATED WITH THIS PTA INSTEAD. THE BALLOON RUPTURED DURING THE FIRST INFLATION AT AN UNKNOWN PRESSURE. THE DEVICE WAS REMOVED AND AN UNSPECIFIED 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 9457349 ↗
• MalfunctionDec 3, 2019Leak/Splash; Material Rupture; Leak/Splash; Material Rupture

  IT WAS REPORTED THAT THERE WAS AN UNKNOWN ISSUE WITH THE 3.0 X 60 MM ARMADA. THE DEVICE WAS PREPPED OUTSIDE THE ANATOMY PRIOR TO USE WITHOUT ANY ISSUES. A SECOND BALLOON WAS USED TO COMPLETE THE PROCEDURE WITHOUT ANY ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED. DEVICE ANALYSIS REVEALED FLUID WAS OBSERVED COMING OUT FROM A PINHOLE RUPTURE IN THE BALLOON.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9403114 ↗
• MalfunctionJul 10, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE 3.0 X 60 MM ARMADA 14 BALLOON RUPTURED DURING INFLATION. NO ADVERSE PATIENT EFFECT OR CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7675695 ↗
• MalfunctionJan 29, 2018Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED, LEFT SUPERFICIAL FEMORAL ARTERY. THE 3.0X60M ARMADA 14 BALLOON DILATATION CATHETER (BDC) WAS ADVANCED WITHOUT ISSUE TO THE TARGET LESION. THE BALLOON RUPTURED DURING THE FIRST INFLATION TO 8-10 ATMOSPHERES. THE BDC WAS REMOVE WITHOUT ISSUE AND A 3.0X40M ARMADA 14 BDC WAS ADVANCED WITHOUT ISSUE AND IT ALSO RUPTURED DURING THE FIRST INFLATION TO 8-10 ATMOSPHERES. A NEW ARMADA 14 BDC WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7225814 ↗
• MalfunctionDec 19, 2017Leak/Splash

  IT WAS REPORTED THAT DURING PREPARATION OF THE 3.0 X 60 MM ARMADA 14 BALLOON DILATATION CATHETER (BDC) WHILE PULLING NEGATIVE, AIR WAS BEING PULLED BACK. NO DAMAGE WAS VISIBLY DETECTED; HOWEVER, IT WAS SUSPECTED THAT THERE WAS A HOLE IN THE BALLOON. THE DEVICE WAS NOT USED IN THE ANATOMY AND WAS REPLACED WITH A NEW ARMADA 14 BDC. THE NEW BDC WAS USED WITH THE SAME INDEFLATOR AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 7132290 ↗
• MalfunctionJun 27, 2017Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A FEMORAL ARTERY. A 1.5 X 80 MM ARMADA 14 BALLOON WAS BEING INFLATED WHEN IT RUPTURED AT 14 ATMOSPHERES AFTER BEING INFLATED 2 TO 3 TIMES. THEN A 3.0 X 60 MM ARMADA 14 BALLOON WAS BEING INFLATED WHEN IT ALSO RUPTURED AT 14 ATMOSPHERES AFTER BEING INFLATED 2 TO 3 TIMES. ANOTHER UNSPECIFIED BALLOON CATHETER WAS SUCCESSFULLY USED TO COMPLETE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6669971 ↗
• MalfunctionFeb 14, 2017Inflation Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A PERIPHERAL ARTERY PROCEDURE. THE 3.0 X 60 MM ARMADA 14 AND THE 3.0 X 20 MM ARMADA 14 DILATATION CATHETERS WERE EACH ADVANCED TO THE TARGET LESION IN THE ANTERIOR TIBIAL ARTERY, WITHOUT DIFFICULTY. ATTEMPTS WERE MADE TO INFLATE THE BALLOONS; HOWEVER, FOR EACH DEVICE, THE BALLOON WOULD NOT INFLATE. THERE WAS NO ADVERSE PATIENT EFFECT. THE DEVICES WERE ABLE TO BE REMOVED FROM THE PATIENT ANATOMY WITHOUT DIFFICULTY AND THE TARGET LESION WAS TREATED WITH AN ADDITIONAL DEVICE. THE 4.0 X 20 MM ARMADA 14 DILATATION CATHETER WAS ADVANCED TO THE TARGET LESION IN THE HEAVILY CALCIFIED SUPERFICIAL FEMORAL ARTERY (SFA); HOWEVER, DURING THE SECOND INFLATION, THE BALLOON RUPTURED AT 8 ATMOSPHERES (ATM). THE DEVICE WAS REMOVED WITHOUT ISSUE AND THERE WAS NO ADVERSE PATIENT EFFECT. A SECOND DEVICE WAS USED SUCCESSFULLY TO COMPLETE DILATATION OF THE SFA. THERE WAS NO ADDITIONAL INFORMATION PROVIDED REGARDING THE ABOVE MENTIONED DEVICES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6330966 ↗