Armada B2070-150Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 08717648155406), received between Nov 4, 2016 and Feb 12, 2025 — classified as 1 injury, 11 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 12, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE RIGHT SUPERFICIAL FEMORAL ARTERY (RSFA). THE 7X150MM ARMADA BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION AND THE BALLOON WAS INFLATED; HOWEVER, THE BALLOON RUPTURED DURING THE SECOND INFLATION AT 10 ATMOSPHERES (ATM). AN UNSPECIFIED BALLOON FOLLOWED BY STENTING WAS USED TO COMPLETE 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 21367817 ↗
• 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 7.0X80MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) WAS ATTEMPTED TO BE USED FOR VESSEL DILATATION; HOWEVER DURING THE FIRST INFLATION THE BALLOON WAS NOTED TO RUPTURE AT 4 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 20724141 ↗
• 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 7.0X150MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) WAS ATTEMPTED TO BE USED FOR VESSEL DILATATION; HOWEVER DURING THE FIRST 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 20723973 ↗
• MalfunctionFeb 19, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA) WITH 70% STENOSIS, HEAVY CALCIFICATION AND NO TORTUOSITY. TWO 7.0X150MM ARMADA 35 BALLOON DILATATION CATHETERS (BDC) WERE ADVANCED WITHOUT RESISTANCE BUT RUPTURED DURING THE FIRST INFLATION AT 8 ATMOSPHERES (ATMS). ANOTHER ARMADA 35 BALLOON 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 18730651 ↗
• MalfunctionFeb 19, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA) WITH 70% STENOSIS, HEAVY CALCIFICATION AND NO TORTUOSITY. TWO 7.0X150MM ARMADA 35 BALLOON DILATATION CATHETERS (BDC) WERE ADVANCED WITHOUT RESISTANCE BUT RUPTURED DURING THE FIRST INFLATION AT 8 ATMOSPHERES (ATMS). ANOTHER ARMADA 35 BALLOON 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 18730648 ↗
• InjuryDec 13, 2022Material Rupture; Material Separation; Material Rupture; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY TORTUOUS UNSPECIFIED LESION. THE 7.0X150MM ARMADA 35 BALLOON DILATATION CATHETER RUPTURE ON THE THIRD INFLATION AT 8 ATMOSPHERES. THE BALLOON FRAGMENTED IN THE ARTERY LEAVING FOREIGN MATERIAL IN THE PATIENT. THE FRAGMENTS WERE REMOVED WITH A SNARE DEVICE; HOWEVER, NOT ALL OF THE FRAGMENT WAS SNARED. A SMALL PIECE THAT IS LEFT IS INERT AND IS EMBEDDED THE SUBCUTANEOUS TISSUE. A NON-ABBOTT COMPLIANT BALLOON DEVICE WAS SUCCESSFULLY USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT SEQUELA REPORTED; HOWEVER, CLINICALLY SIGNIFICANT DELAY WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 15971268 ↗
• MalfunctionFeb 23, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING THE TREATMENT OF A SEVERELY CALCIFIED, RIGHT SUPERFICIAL FEMORAL ARTERY (SFA), THE ARMADA 35 PTA BALLOON RUPTURED ON THE 1ST INFLATION, AT 6 ATMOSPHERES (ATM). THE DEVICE WAS REMOVED WITHOUT ISSUE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. ANOTHER SAME SIZED ARMADA BALLOON WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 11369720 ↗
• MalfunctionFeb 7, 2018Inflation Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE NON-TORTUOUS, MILDLY CALCIFIED, 80% STENOSED, PROXIMAL TO MID SUPERFICIAL FEMORAL ARTERY (SFA). A 7.0 X 150 MM ARMADA 35 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER WAS SELECTED FOR THE PROCEDURE. THE PTA CATHETER WAS ADVANCED TO THE LESION AND WOULD NOT INFLATE. THE PTA CATHETER WAS REMOVED FROM THE ANATOMY AND REPLACED WITH A NEW 7.0 X 100 MM ARMADA 35 PTA CATHETER TO SUCCESSFULLY COMPLETE THE PROCEDURE. THE PHYSICIAN SPECULATED THAT THE LUER LOCK CONNECTOR ON THE HUB MAY HAVE A CRACK, ALTHOUGH NO CRACK WAS OBSERVED. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7248727 ↗
• MalfunctionOct 7, 2017Material Rupture

  IT WAS REPORTED THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA) AND THE ILIAC VESSEL, BOTH WITH MODERATE CALCIFICATION. THE 7X150MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE SFA LESION WITHOUT ISSUE, BUT RUPTURED AT 5 ATMOSPHERES. THE BDC WAS REMOVED WITHOUT ISSUE AND REPLACED WITH A NEW ARMADA 35 BDC. THE 6.0X60MM ABSOLUTE PRO VASCULAR STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE ILIAC LESION. MID-DEPLOYMENT, THE THUMBWHEEL JAMMED. THE HANDLE WAS CRACKED OPEN, AND THE STENT WAS DEPLOYED MANUALLY. 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 6927294 ↗
• MalfunctionFeb 27, 2017Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO LESION LOCATED IN THE RIGHT SUPERFICIAL FEMORAL ARTERY (SFA) WITH HEAVY CALCIFICATION. RESISTANCE WAS NOT FELT DURING ADVANCEMENT OF THE 7 MM X 150 MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) TO THE LESION; HOWEVER, THE BALLOON RUPTURED DURING THE FIRST INFLATION AT 8 ATMOSPHERES. A NEW BDC WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6362460 ↗
• MalfunctionFeb 1, 2017Material Rupture

  IT WAS REPORTED THAT DURING A PROCEDURE TO TREAT A MODERATELY CALCIFIED SUPERFICIAL FEMORAL ARTERY, A 7.0 MM X 150 MM X 135 CM ARMADA 35 LL BDC WAS THEN ADVANCED WITHOUT ISSUE. DURING THE 3RD INFLATION TO NOMINAL PRESSURE, THE BALLOON RUPTURED, HOWEVER, THERE WERE NO ADVERSE PATIENT EFFECTS AND NO OCCURRENCE OF A CLINICALLY SIGNIFICANT DELAY. THE ARMADA 35 LL WAS WITHDRAWN FROM THE ANATOMY. THE PROCEDURE WAS COMPLETED WITH ANOTHER UNSPECIFIED BALLOON CATHETER WITHOUT ISSUE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6294539 ↗
• MalfunctionNov 4, 2016Material Rupture

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA). THE 6.0 X 200 MM ARMADA 18 BALLOON CATHETER WAS ADVANCED TO THE TARGET LESION FOR PRE-DILATATION AND WAS INFLATED AND DEFLATED SUCCESSFULLY. THE DEVICE WAS WITHDRAWN WITHOUT ISSUES FROM THE PATIENT ANATOMY. THE 7.0 X 150 MM ARMADA 35 WAS ADVANCED TO THE TARGET LESION FOR ADDITIONAL PRE-DILATATION; HOWEVER, THE BALLOON RUPTURED AT 8 ATMOSPHERES DURING THE FIRST INFLATION. THE ARMADA 18 BALLOON WAS TO BE USED FOR POST DILATATION; HOWEVER, IT COULD NOT BE RE-INSERTED INTO THE SHEATH DUE TO THE BALLOON FOLDS. A NEW ARMADA BALLOON CATHETER WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6080822 ↗