Armada B2060-060Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 08717648155277), received between Nov 18, 2016 and Apr 29, 2026 — classified as 2 injuries, 19 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (17 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 29, 2026Leak/Splash

  IT WAS REPORTED THAT DURING PREPARATION OF THE 6.0X60MM ARMADA 35 BALLOON DILATATION CATHETER, THE BALLOON WOULD NOT HOLD NEGATIVE PRESSURE INDICATING THAT THERE WAS A LEAK SOMEWHERE IN SYSTEM. MULTIPLE ATTEMPTS MADE TO VERIFY IT WASN'T USER ERROR. AN UNSPECIFIED DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DEVICE USE OR PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25033420 ↗
• MalfunctionApr 9, 2026Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A DE NOVO, HEAVILY CALCIFIED, MODERATELY TORTUOUS SUPERFICIAL FEMORAL ARTERY THAT IS 70% STENOSED. ONCE AT THE LESION, THE 6.0X60MM ARMADA 35 BALLOON DILATATION CATHETER WAS INFLATED ONCE AND RUPTURED AT 8 ATMOSPHERES. AN UNSPECIFIED BALLOON 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 24832548 ↗
• MalfunctionOct 25, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE LEFT EXTERNAL ILLIAC ARTERY WITH MODERATE CALCIFICATION AND NO TORTUOSITY. THE 6X80 MM ARMADA 18 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER WAS INFLATED ONCE TO 6 ATMOSPHERES AND RUPTURED. THE 6X60 MM ARMADA 35 PTA CATHETER WAS USED INSTEAD; HOWEVER, IT ALSO RUPTURED ON THE FIRST INFLATION TO 5 ATMOSPHERES. A NEW NON-ABBOTT BALLOON 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 20534152 ↗
• MalfunctionOct 24, 2023Material Rupture; Material Rupture

  SUBSEQUENT TO THE INITIAL REPORT BEING FILED THE FOLLOWING INFORMATION WAS RECEIVED. THE ARMADA BALLOON DILATATION CATHETER WAS PREPPED PER IFU BEFORE USE. THE BALLOON RUPTURED DURING THE 1ST INFLATION AT 6 ATMOSPHERES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17998875 ↗
• MalfunctionAug 22, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE LEFT POPLITEAL ARTERY. FOR PRE-DILATATION, THE 6.0X60MM ARMADA BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION WITH NO RESISTANCE AND THE BALLOON WAS INFLATED; HOWEVER, A RUPTURE OCCURRED AFTER 5 INFLATIONS AT 15 ATMOSPHERES. THE BDC WAS REMOVED FROM THE PATIENT AND A NON-ABBOTT STENT WAS DEPLOYED 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 17597699 ↗
• MalfunctionJul 24, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE 6.0X60 MM ARMADA 35 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER RUPTURED. ANOTHER ABBOTT BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO 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 17380684 ↗
• MalfunctionJul 20, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE 6.0X60 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 17367295 ↗
• InjuryJul 10, 2023Entrapment of Device; Off-Label Use; Material Rupture; Entrapment of Device; Off-Label Use; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE SUPERIOR MESENTERIC (SMA) ARTERY WITH HEAVY CALCIFICATION. THE ARMADA 35 PTA PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER WAS INFLATED ONCE AND A RUPTURE OCCURRED AT 15 ATMOSPHERES. DURING REMOVAL, THE CATHETER BECAME STUCK WITH THE 6F SHEATH AND COULD NOT BE REMOVED FROM THE ILIAC ARTERY; THEREFORE, A CUT DOWN WAS PERFORMED AND THE DEVICES WERE REMOVED TOGETHER. THE PROCEDURE WAS COMPLETED AT THIS POINT WITH THE SAME DEVICE. THERE WERE NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17288638 ↗
• MalfunctionMar 13, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 6MMX60MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) RUPTURED AT 6 ATMOSPHERES (ATM). NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16535088 ↗
• MalfunctionFeb 23, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE SUPERFICIAL FEMORAL ARTERY. THE 6X60MM ARMADA 35 BALLOON DILATATION CATHETER WAS NOTED TO RUPTURE DURING THE PROCEDURE AT AN UNKNOWN PRESSURE. ADDITIONALLY, THE BALLOON WAS FULLY DEFLATED BEFORE REMOVING IT FROM ANATOMY. ANOTHER ARMADA WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13585233 ↗
• MalfunctionMay 26, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY TORTUOUS, HEAVILY CALCIFIED RIGHT COMMON ILIAC ARTERY. A 6.0X60MM AND A 6.0X40MM ARMADA 35 BALLOON WERE ATTEMPTED TO PRE-DILATE THE LESION; HOWEVER, BOTH BALLOONS REPORTEDLY RUPTURED AT 4 ATMOSPHERES (ATM). BOTH DEVICES WERE REMOVED WITHOUT ISSUE AND A 7.0X59MM OMNILINK STENT WAS IMPLANTED AND A 9.0X60MM ARMADA'S 35 WAS ATTEMPTED TO POST DILATE, BUT RUPTURED AT 6 ATM. THERE WAS NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11886018 ↗
• MalfunctionMar 5, 2021Material Rupture; Material Rupture

  ON HOLD FOR KD 3.16IT WAS REPORTED THAT THIS WAS A PROCEDURE TO TREAT A LESION IN THE SUPERFICIAL FEMORAL ARTERY. THE ARMADA BALLOON CATHETER WAS ADVANCED TO THE LESION, BUT THE BALLOON RUPTURED AT UNKNOWN PRESSURE. AN UNSPECIFIED BALLOON CATHETER WAS USED SUCCESSFULLY IN THE PROCEDURE. A SUPERA STENT WAS IMPLANTED SUCCESSFULLY. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11424231 ↗
• MalfunctionAug 17, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE SUPERFICIAL FEMORAL ARTERY. DURING USE, THE ARMADA 35 DILATATION CATHETER BALLOON RUPTURED AT AN UNKNOWN PRESSURE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY. A SECOND SAME DEVICE WAS USED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10417868 ↗
• MalfunctionJun 23, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING PREPARATION OF THE 6X60MM ARMADA 35 BALLOON DILATATION CATHETER, AIR WAS LEAKING WHILE PULLING NEGATIVE WITH THE INDEFLATOR. THERE WAS NO PATIENT INVOLVEMENT. 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 10183984 ↗
• MalfunctionApr 16, 2020Deflation Problem; Difficult to Remove; Improper or Incorrect Procedure or Method; Deflation Problem; Difficult to Remove; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO MILDLY TORTUOUS, MILDLY CALCIFIED SUPERFICIAL FEMORAL ARTERY THAT WAS 85% STENOSED. A 6X60MM ARMADA BALLOON WAS ADVANCED TO THE LESION AND INFLATED WITHOUT ISSUE. WHILE WITHDRAWING THE ARMADA BALLOON IT WAS NOTED THAT THERE WAS RESISTANCE MET WITH THE INTRODUCER SHEATH AS THE BALLOON ONLY PARTIALLY DEFLATED. REPEATED SUCTION OF THE PRESSURE PUMP FAILED TO FULLY DEFLATE THE BALLOON. EXCESSIVE FORCE WAS ADDED TO REMOVE THE DEVICE. THERE WAS NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9969838 ↗
• MalfunctionNov 21, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN AN UNSPECIFIED ARTERY. A 6X60 MM ARMADA 35 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER RUPTURED AT AN UNKNOWN ATMOSPHERE BELOW RATED BURST PRESSURE. A NEW SAME SIZE ARMADA 35 PTA CATHETER WAS USED SUCCESSFULLY TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT AND THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8096603 ↗
• InjuryApr 25, 2018Detachment Of Device Component; Difficult to Remove; Material Rupture

  IT WAS REPORTED THAT PROCEDURE WAS TO TREAT A LESION IN A HEAVILY CALCIFIED, 80% STENOSED, RIGHT SUPERFICIAL FEMORAL ARTERY. A 6 X 60 MM ARMADA 35 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER WAS ADVANCED TO THE LESION WITHOUT RESISTANCE. THE BALLOON WAS INFLATED TO 10 ATMOSPHERES, BUT ON THE SECOND INFLATION THE BALLOON RUPTURED BEFORE REACHING NOMINAL PRESSURE. DURING REMOVAL OF THE PTA CATHETER FROM THE ANATOMY, THE BALLOON CAUGHT ON THE EDGE OF THE UNSPECIFIED 6F SHORT INTRODUCER SHEATH AND A PORTION OF THE BALLOON SEPARATED FROM THE SHAFT. THE PTA CATHETER WAS REMOVED FROM THE ANATOMY. THE 6F SHORT INTRODUCER SHEATH WAS REMOVED FROM THE ANATOMY AND REPLACED WITH A LONGER INTRODUCER SHEATH IN AN UNSUCCESSFUL ATTEMPT TO CAPTURE THE BALLOON FRAGMENT. A CUT DOWN PROCEDURE WAS PERFORMED TO REMOVE THE BALLOON FRAGMENT FROM THE ANATOMY. THE PROCEDURE WAS COMPLETED WITH THE SUCCESSFUL DEPLOYMENT OF AN UNSPECIFIED STENT IMPLANT. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7459268 ↗
• MalfunctionFeb 8, 2018Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE RIGHT SUPERFICIAL FEMORAL ARTERY. THE 6.0X60M ARMADA 35 BALLOON DILATATION CATHETER (BDC) WAS ADVANCED WITHOUT ISSUE TO THE TARGET LESION. DURING INFLATION TO 6 ATMOSPHERES, THE BALLOON BEGAN TO LEAK. THE SAME BDC WAS CONTINUED TO BE USED TO COMPLETE THE PROCEDURE. THE BDC WAS REMOVED WITHOUT ISSUE. 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 7252685 ↗
• MalfunctionJan 18, 2018Crack; Leak/Splash

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE SUPERFICIAL FEMORAL ARTERY. THE 6MMX60MMX135CM ARMADA 35 BALLOON DILATATION CATHETER (BDC) WAS ADVANCED IN THE PATIENT ANATOMY HOWEVER, DURING INFLATION OF THE BALLOON A LEAK WAS NOTED COMING FROM A CRACK ON THE HUB OF THE ARMADA 35 BALLOON BDC. A NEW BDC 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 7204093 ↗
• MalfunctionDec 6, 2016Material Rupture

  IT WAS REPORTED THAT DURING A PROCEDURE TO TREAT A HEAVILY CALCIFIED DISTAL SUPERFICIAL FEMORAL ARTERY, A 6MM X 60 MM X 135 CM ARMADA 35 BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION. DURING THE SECOND INFLATION, THE BALLOON RUPTURED AT 10 ATMOSPHERES. THE BDC WAS REPLACED WITH A NEW UNSPECIFIED ARMADA BDC 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 Consequences Or Impact To Patient

  MAUDE report 6149967 ↗
• MalfunctionNov 18, 2016Material Rupture

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA). THE 4.0 X 120 MM ARMADA 35 WAS ADVANCED WITHOUT ISSUE TO THE TARGET LESION; HOWEVER, THE BALLOON RUPTURED AT 8 ATMOSPHERE (ATM) AT THE FIRST INFLATION. THE DEVICE WAS WITHDRAWN WITHOUT ANY ISSUES NOTED FROM THE PATIENT ANATOMY. A 6.0 X 60 MM ARMADA 35 WAS ADVANCED SUCCESSFULLY WITHOUT ANY ISSUES TO THE TARGET LESION; HOWEVER, THE BALLOON RUPTURED AT 8 ATM AT THE FIRST INFLATION AS WELL. A NON-ABBOTT BALLOON WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. 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 6114621 ↗