Armada B2070-080Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 08717648155376), received between Feb 23, 2018 and Sep 29, 2026 — classified as 2 injuries, 7 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. 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Break; Inflation Problem; Leak/Splash

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50935933 ↗
• InjuryFeb 5, 2026Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A RIGHT EXTERNAL ILIAC ARTERY. PRE-DILATATION WAS PERFORMED WITH A 7X80MM ARMADA 35 BALLOON DILATATION (BDC. SUBSEQUENTLY, A DISSECTION WAS NOTED. THE BDC POSSIBLY CONTRIBUTED TO THE DISSECTION. THEN AN UNSPECIFIED STENT WAS IMPLANTED TO TREAT THE DISSECTION. POST STENT IMPLANTATION, THE BDC WAS ATTEMPTED TO BE RE-USED. HOWEVER, THE BDC COULD NOT ADVANCE THROUGH THE 5F SHEATH. THEREFORE, THE PROCEDURE WAS COMPLETED WITH ANOTHER ARMADA BDC DEVICE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Vascular Dissection

  MAUDE report 24265347 ↗
• MalfunctionNov 19, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A HEAVILY CALCIFIED LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA). A 7X80MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) WAS ATTEMPTED TO BE USED FOR VESSEL DILATATION; HOWEVER, DURING THE THIRD INFLATION THE BALLOON WAS NOTED TO RUPTURE AT 7 ATMOSPHERES. THE BDC WAS REMOVED AND A NON-ABBOTT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT NOR CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20724097 ↗
• InjuryNov 6, 2024Difficult to Remove; Material Rupture; Material Separation; Difficult to Remove; Material Rupture; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN 80% RE-STENOSED AV FISTULA. THE 7X80MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION AND THE BALLOON WAS INFLATED ONCE; HOWEVER, THE BALLOON RUPTURED AT 12 ATMOSPHERES (ATM). THEREFORE, THE BDC WAS REMOVED AND RESISTANCE WAS NOTED WITH THE SHEATH. A PIECE OF THE BALLOON SEPARATED IN THE ANATOMY AND CUT DOWN SURGERY WAS PERFORMED TO REMOVE THE SEPARATED PIECE OF BALLOON. THERE WAS NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20626017 ↗
• MalfunctionMar 27, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT THE LEFT FEMORAL ARTERY WITH MODERATE CALCIFICATION AND NO TORTUOSITY. THE 9X60 MM ARMADA PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER WAS ADVANCED TO THE LESION WITHOUT RESISTANCE AND INFLATED BUT RUPTURED AT 8 ATMOSPHERES (ATM) DURING THE FIRST INFLATION. A 7X80 MM ARMADA PTA CATHETER WAS ADVANCED TO THE LESION WITHOUT RESISTANCE AND WAS INFLATED BUT RUPTURED AT 8 ATM DURING THE SECOND INFLATION. A THIRD ARMADA PTA CATHETER WAS USED TO COMPLETE THE PROCEDURE WITHOUT ISSUE. 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 18987588 ↗
• MalfunctionNov 1, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED, LESION IN THE LEFT SUPERFICIAL FEMORAL ARTERY. THE 7.0MMX80MMX135CM ARMADA 35 BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION. DURING THE FIRST INFLATION, TO 8 ATMOSPHERES, THE BALLOON RUPTURED. A 7.0MMX60MMX135CM ARMADA 35 BDC WAS ADVANCED TO THE TARGET LESION AND THE BALLOON RUPTURED AT 8 ATMOSPHERES, DURING THE FIRST INFLATION. ANOTHER ARMADA BALLOON WAS USED TO COMPLETE THE PROCEDURE WITHOUT FURTHER ISSUES. 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 12732717 ↗
• MalfunctionOct 23, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE 7.0X80 MM ARMADA 35 WAS ADVANCED TO THE HEAVILY CALCIFIED LESION IN THE RIGHT SUPERFICIAL ARTERY. THE ARMADA WAS INFLATED AT 10 ATMOSPHERES BUT RUPTURED WITH THE FIRST INFLATION DUE TO THE HEAVY CALCIUM. THE ARMADA REMAINED INTACT AND WAS REMOVED FROM THE ARTERY WITHOUT INCIDENT. THE ABSOLUTE PRO VASCULAR WAS SUCCESSFULLY IMPLANTED. THE 8.0X60 ARMADA 35 WAS USED FOR POST DILATATION OF THE STENT. 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 9227306 ↗
• MalfunctionMay 17, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A 95% STENOSED AND HEAVILY CALCIFIED LESION IN THE SUPERFICIAL FEMORAL ARTERY. AFTER NINE PASSES OF ATHERECTOMY WERE PERFORMED, THE 7.0X80MM ARMADA PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER WAS THEN ADVANCED WITHOUT RESISTANCE AND INFLATED AN UNKNOWN NUMBER OF TIMES WHEN THE BALLOON RUPTURED. THE RATED BURST PRESSURE WAS UNKNOWN BUT WAS NOTED TO BE AT OR BELOW NOMINAL. THE DEVICE WAS REMOVED WITHOUT REPORTED ISSUE AND REPLACED WITH ANOTHER ARMADA 35 PTA CATHETER TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT OR A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8621583 ↗
• MalfunctionFeb 23, 2018Difficult to Insert; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT LESION IN THE RIGHT SUPERFICIAL FEMORAL ARTERY. A 7X80MM ARMADA 35 BALLOON CATHETER WAS USED TO PRE-DILATE THE LESION. THE BALLOON CATHETER WAS REMOVED AND AN UNKNOWN STENT WAS IMPLANTED; HOWEVER, WHEN ATTEMPTING TO RE-INSERT THE BALLOON CATHETER FOR POST-DILATATION IT COULD NOT BE INSERTED IN THE SHEATH. A 7X60MM ARMADA 35 BALLOON CATHETER WAS USED TO POST-DILATE THE STENT. THE BALLOON CATHETER WAS REMOVED AND AN ATTEMPT TO INSERT IT AGAIN FOR ADDITIONAL POST-DILATATION WAS MADE; HOWEVER, IT COULD NOT BE INSERTED INTO THE SHEATH. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH 7X80MM NON-ABBOTT BALLOON CATHETER. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED. THE RETURN DEVICE ANALYSIS NOTED PINHOLE RUPTURES IN BOTH OF THE ARMANDA BALLOONS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7293121 ↗