Armada B1060-060Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 08717648154706), received between Nov 16, 2017 and May 29, 2026 — classified as 7 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (10 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 29, 2026Leak/Splash

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN AV FISTULA IN A MILDLY CALCIFIED AND MILDLY TORTUOUS VESSEL. THE 6.0X60MM ARMADA 35 BALLOON DILATATION CATHETER WAS INFLATED TO NOMINAL PRESSURE WHEN A LEAK AT THE DISTAL PART OF THE WIRE PORT WHERE IT CONNECTS TO THE BLACK CONNECTION [HUB], WAS NOTED. AN UNSPECIFIED DEVICE 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 25334143 ↗
• MalfunctionJan 29, 2026Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A MILDLY TORTUOUS, MODERATELY STENOSED LEFT AV FISTULA IN THE BASILIC VEIN. DURING ADVANCEMENT OF THE 6.0X60MM ARMADA 35 BALLOON DILATATION CATHETER (BDC), RESISTANCE WAS NOTED DUE TO ANATOMY. ONCE AT THE LESION, THE ARMADA 35 BDC RUPTURED AT 15 ATMOSPHERES DURING THE SECOND INFLATION. 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 24211111 ↗
• MalfunctionNov 13, 2025Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE COMMON FEMORAL ARTERY (CFA) WITH HEAVY CALCIFICATION AND HEAVY TORTUOSITY. THE 6.0X60MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) HAD RESISTANCE DURING ADVANCEMENT WITH THE ANATOMY AND RUPTURED DURING THE FIRST INFLATION BEFORE REACHING NOMINAL PRESSURE. THE DEVICE WAS PREPARED PER INSTRUCTIONS FOR USE (IFU). ANOTHER ABBOTT BALLOON, JADE, 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 23550291 ↗
• MalfunctionNov 13, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING PREPARATION OF A 6.0X60MM ARMADA 35 BALLOON DILATATION CATHETER, AIR WAS LEAKING FROM A HOLE OF THE ARMADA 35 BALLOON. A NEW ARMADA 35 WAS PREPARED AND USED TO COMPLETE THE PROCEDURE. THERE WAS NO DEVICE USE OR PATIENT INVOLVEMENT, AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23548070 ↗
• InjuryApr 21, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A FISTULA IN AN UNKNOWN VESSEL. DURING REMOVAL OF A 6.0X60MM ARMADA 35 BALLOON DILATATION CATHETER (BDC), THE BDC DETACHED. THE BDC WAS SNARED INTO THE GUIDING CATHETER AND THE GUIDING CATHETER WITHDRAWN WITH THE DETACHED ARMADA BDC INSIDE. A NEW DEVICE WAS NOT NEEDED AS THIS HAPPENED AT THE END OF THE PROCEDURE. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21876527 ↗
• InjuryDec 2, 2024Difficult to Remove; Material Rupture; Material Separation; Difficult to Remove; Material Rupture; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A BRACHIAL ARTERY THAT IS HEAVILY CALCIFIED, MODERATELY TORTUOUS. THE 6.0X60MM ARMADA 35 BALLOON DILATATION CATHETER RUPTURED DURING THE THIRD INFLATION FROM 8 TO 10 ATMOSPHERES. WHEN ATTEMPTING TO REMOVE THE BALLOON RESISTANCE WAS FELT WITH A PREVIOUSLY UNSPECIFIED STENT AND THE BALLOON SEPARATED. A CUT DOWN WAS PERFORMED TO REMOVE THE SEPARATED BALLOON. ANOTHER UNSPECIFIED DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20821898 ↗
• MalfunctionJul 17, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT AN ARTERIOVENOUS FISTULA WITH THE 6.0X60MM ARMADA 35 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CATHETER. THE ARMADA WAS INFLATED ONCE TO LESS THAN THEN THE RATED BURST PRESSURE WHEN THE BALLOON RUPTURED. ANOTHER ABBOTT DEVICE 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 19763796 ↗
• InjuryApr 27, 2023Difficult to Remove; Material Rupture; Material Separation; Difficult to Remove; Material Rupture; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED COMMON ILIAC ARTERY. THE 6.0X60MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) WAS INFLATED TO 6 ATMOSPHERES AND RUPTURED. NEGATIVE WAS PULLED AS DEVICE WAS BEING REMOVED AND MORE RESISTANCE THAN USUAL WAS FELT. THE BDC WAS STUCK ON THE GUIDE WIRE AND WOULD NOT COME OUT OF THE 6FR SHEATH. THE DEVICE SEPARATED AT THE BALLOON. THE SEPARATED PORTION COULD NOT BE REMOVED FROM THE PATIENT; THEREFORE, IT WAS TRAPPED AGAINST THE VESSEL WALL WITH AN UNSPECIFIED BALLOON-EXPANDABLE STENT. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 16824787 ↗
• MalfunctionOct 20, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED, MILDLY TORTUOUS DE NOVO SUPERFICIAL FEMORAL ARTERY. THE 6.0X60MM ARMADA 35 BALLOON DILATATION CATHETER RUPTURED DURING FIRST INFLATION AT NOMINAL PRESSURE. ANOTHER 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 15640588 ↗
• MalfunctionJun 29, 2022Deflation Problem; Inflation Problem; Difficult to Remove; Improper or Incorrect Procedure or Method; Deflation Problem; Inflation Problem; Difficult to Remove; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A FISTULA IN THE RIGHT ARM. THE 6.0X60MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION AND INFLATED TO NOMINAL PRESSURE; HOWEVER, THE BALLOON DID NOT LOOK LIKE IT WAS COMPLETELY INFLATING. THE BALLOON WAS INFLATED TO RATED BURST PRESSURE (RBP), BUT STILL DID NOT SEEM TO FULLY EXPAND. AN ATTEMPT WAS MADE TO DEFLATE THE BALLOON; HOWEVER, IT WOULD NOT FULLY DEFLATE. THE DEVICE WAS SLOWLY REMOVED UNDER NEGATIVE PRESSURE WITH RESISTANCE NOTED. OUTSIDE THE PATIENT THE BALLOON STILL WOULD NOT DEFLATE. ANOTHER BDC WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14852358 ↗
• InjuryDec 22, 2020Difficult to Remove; Material Rupture; Difficult to Remove; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED STENOSED ILIAC ARTERY. A NON-ABBOTT J-WIRE WAS ADVANCED TO THE LESION. THEN A 6X60MM ARMADA BALLOON WAS ADVANCED TO THE LESION AND WHEN INFLATED IT RUPTURED AT AN UNSPECIFIED ATMOSPHERE. THE DEVICE WAS THEN PINCHED AND PULLED OFF THE GUIDE WIRE, BUT DID NOT COMPLETELY COME OUT AS THE PROXIMAL PART OF THE BALLOON WAS STILL ON THE WIRE. THE SHEATH WAS UPSIZED TO A 7FR SHEATH AND BOTH DEVICES WERE ABLE TO BE PULLED OUT TOGETHER (BALLOON STUCK ON GUIDE WIRE). NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11057620 ↗
• MalfunctionNov 17, 2020Leak/Splash; Improper or Incorrect Procedure or Method; Leak/Splash; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE FEMORAL ARTERY. THE 6.0X60MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE LESION. AIR ASPIRATION WAS PERFORMED IN THE ANATOMY BEFORE DILATATION, HOWEVER; BLOOD WAS OBSERVED IN THE HUB THEREFORE A LEAK WAS SUSPECTED AND THE BDC WAS REMOVED. A NON-ABBOTT DEVICE 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 10852866 ↗
• InjuryJul 31, 2020Material Rupture; Material Separation; Improper or Incorrect Procedure or Method; Material Rupture; Material Separation; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A RE-STENOSED LESION IN A FISTULA VEIN THAT WAS MODERATELY TORTUOUS AND 80% STENOSED THAT WAS TREATED EIGHT MONTHS PRIOR. AN UNSPECIFIED 6 FRENCH SHEATH AND A 035 NON-ABBOTT GUIDE WIRE WERE USED WITH A 6X60MM ARMADA 35 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER. THE PTA BALLOON WAS INFLATED TWICE TO 20 ATMOSPHERES WHEN IT RUPTURED. THE PTA CATHETER WAS REMOVED, AND THE PROCEDURE WAS COMPLETE. THREE DAYS LATER, THE PATIENT CAME BACK WITH A SWOLLEN HAND. ECHOCARDIOGRAPHY WAS PERFORMED AND IT WAS DETERMINED THAT THIS SWELLING WAS DUE TO A PORTION OF THE ARMADA BALLOON CATHETER THAT HAD SEPARATED IN THE PREVIOUS PROCEDURE AND WAS STILL IN THE TREATED AREA OF THE FISTULA VEIN. A SMALL SURGICAL INCISION WAS MADE IN THE FISTULA AREA TO REMOVE THE SEPARATED PORTION, AND THE PATIENT WAS FINE. THERE WERE NO ADVERSE PATIENT SEQUELAE AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Swelling

  MAUDE report 10350479 ↗
• MalfunctionNov 4, 2019Leak/Splash; Material Split, Cut or Torn; Leak/Splash; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING PREPARATION OF THE 6.0X60MM ARMADA 35 BALLOON DILATATION CATHETER, A HOLE AND AIR LEAK WERE NOTED IN THE BALLOON WHILE PULLING NEGATIVE. THE DEVICE WAS NOT USED AND REPLACED WITH A NEW SAME SIZE ARMADA BALLOON. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 9273756 ↗
• InjuryOct 18, 2019Difficult to Remove; Material Rupture; Material Separation; Difficult to Remove; Material Rupture; Material Separation

  RETURNED DEVICE ANALYSIS IDENTIFIED A SEPARATED SHAFT AS WELL AS CUT MARKS. FOLLOW UP WITH THE ACCOUNT CONFIRMED THAT THEY WERE AWARE OF THE SHAFT SEPARATION AND CUT MARKS. THE ACCOUNT DECLINED TO PROVIDE ADDITIONAL INFORMATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9209592 ↗
• InjuryNov 16, 2017Detachment Of Device Component; Entrapment of Device; Material Rupture; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 100% STENOSED AND HEAVILY CALCIFIED RESTENOSED LESION IN THE EXTERNAL ILIAC ARTERY. FOLLOWING PRE-DILATATION, A 7X59MM OMNILINK ELITE STENT WAS IMPLANTED. THE STENT HAD 15% RESIDUAL RESTENOSIS; THEREFORE, A 6X60MM ARMADA 35 BALLOON CATHETER WAS ADVANCED AND INFLATED PAST THE RATED BURST PRESSURE TO FULLY APPOSE THE STENT. THE BALLOON RUPTURED CIRCUMFERENTIALLY. DURING AN ATTEMPT TO REMOVE THE RUPTURED BALLOON PARTS OF THE BALLOON BECAME STUCK WITH THE STRUTS OF THE IMPLANTED STENT AND CAUSED THE BALLOON CATHETER TO SEPARATE. THE PROXIMAL PART OF THE BALLOON CATHETER WAS REMOVED. TO REMOVE THE ENTRAPPED DISTAL PORTION OF THE BALLOON, A NON-ABBOTT WIRE WAS ADVANCED ON THE LEFT SIDE AND AN 8F INTRODUCER WAS CROSSED OVER TO THE RIGHT COMMON ILIAC ARTERY. THE NON-ABBOTT WIRE WAS PULLED THROUGH FROM LEFT TO RIGHT; HOWEVER, THE TIP OF THE WIRE GOT STUCK IN THE PREVIOUS IMPLANTED STENT RESULTING IN STENT STRUTS BECOMING FLARED. AN UNKNOWN 5MM DILATATION CATHETER WAS ADVANCED VIA THE LEFT SIDE AND WHILE PERFORMING SUCCESSIVE DILATATION OF THE BALLOON, THE SEPARATED DISTAL PART OF THE ARMADA 35 BALLOON CATHETER WAS REMOVED FROM THE STENT STRU

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7039695 ↗