Armada 1013470-100Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 08717648208423), received between Jan 29, 2018 and Apr 3, 2025 — classified as 21 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 3, 2025Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A SEVERELY STENOSED LESION IN THE LEFT POPLITEAL ARTERY. AN ARMADA 18 BALLOON DILATATION CATHETER (BDC) WAS PREPARED PER THE INSTRUCTIONS FOR USE (IFU) WITH NO NOTED ISSUES AND ADVANCED TO THE LESION THROUGH RESISTANCE; HOWEVER, DURING THE SECOND INFLATION AT 14ATMS THE BALLOON WAS NOTED TO RUPTURE. THEREFORE, THE DEVICE WAS REMOVED AND THE PROCEDURE WAS CONTINUED USING A NON-ABBOTT BDC. THERE WERE NO ADVERSE PATIENT EFFECTS NOR CLINICAL DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21763378 ↗
• MalfunctionMar 14, 2025Deflation Problem; Difficult to Remove; Improper or Incorrect Procedure or Method; Deflation Problem; Difficult to Remove; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA). THE 6.0X100MM ARMADA 18 BALLOON DILATATION CATHETER WAS ADVANCED INTO THE PATIENT ANATOMY AND AIR ASPIRATION PERFORMED. THE BALLOON WAS INFLATED TO 8 ATMOSPHERES THREE TIMES. THE BALLOON WOULD NOT FULLY DEFLATE AND COULD NOT BE REMOVED THROUGH THE SHEATH. THE BALLOON CATHETER AND SHEATH WERE REMOVED AS A SINGLE UNIT AND THE PROCEDURE COMPLETED. 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 21606023 ↗
• MalfunctionJan 19, 2024Break; Difficult to Advance; Break; Difficult to Advance

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE ARMADA 18 BALLOON DILATION CATHETER (BDC) MET RESISTANCE WITH THE SHEATH AND WAS UNABLE TO COMPLETELY ADVANCE INTO THE SHEATH, CAUSING A BACK AND FORTH MOTION. UPON REMOVAL OF THE BDC, THE PORTION THE SHAFT THE MARKER WAS ATTACHED TO WAS NOTED TO BE LOOSE YET STILL ATTACHED. NO FORCE WAS NOTED DURING ADVANCEMENT AND THERE WAS NO RESISTANCE WHEN REMOVING THE BDC FROM THE SHEATH OR THE HOOP. THE BDC WAS NOT USED. THE PROCEDURE WAS COMPLETED WITH ANOTHER ARMADA 18 BDC. 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 18544748 ↗
• MalfunctionDec 22, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE DISTAL SUPERFICIAL FEMORAL ARTERY (SFA) / PERONEAL VESSEL WITH SEVERE STENOSIS AND MILD TORTUOSITY. THE 6.0X100MM ARMADA 18 BALLOON DILATATION CATHETER (BDC) HAD NO RESISTANCE DURING ADVANCEMENT AND WAS INFLATED TWICE AT 8 ATMOSPHERES (ATMS) EACH BUT RUPTURED DURING THE SECOND INFLATION. THE BALLOON WAS REMOVED. ANOTHER SAME SIZE ARMADA 18 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 18387814 ↗
• MalfunctionAug 23, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED, MILDLY TORTUOUS, 98% STENOSED LESION IN THE DISTAL SUPERFICIAL FEMORAL ARTERY (DSFA). AFTER LEFT GROIN ACCESS WAS OBTAINED, TWO NON-ABBOTT BALLOONS WERE ADVANCED AND BOTH RUPTURED, SO IT WAS DECIDED TO SWITCH TO ABBOTT DEVICES. A 6MMX80MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) WAS ADVANCED. RESISTANCE WAS NOTED WITH THE ANATOMY. THE BDC REACHED THE LESION AND WAS INFLATED ONE TIME TO NOMINAL PRESSURE WHEN THE BALLOON RUPTURED. THE BDC WAS REMOVED WITHOUT ISSUE. A 6.0MMX100MMX150CM ARMADA 18 BDC WAS THEN ADVANCED WITHOUT RESISTANCE. THE BDC MADE IT TO THE TARGET LESION AND WAS INFLATED ONE TIME TO 10 ATMOSPHERES (ATM), BUT THE BALLOON RUPTURED. THE BDC WAS REMOVED WITHOUT ANY ISSUES. ANOTHER SAME SIZED ARMADA 18 BDC WAS ADVANCED WITHOUT ISSUE AND WAS USED TO SUCCESSFULLY COMPLETED DILATATION. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAYS IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17607783 ↗
• MalfunctionMay 4, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED LEFT SUPERFICIAL FEMORAL ARTERY (SFA). THE BALLOON OF A 6.0X100MM ARMADA 18 BALLOON DILATATION CATHETER (BDC) WAS INFLATED; HOWEVER, RUPTURED DURING THE FIRST INFLATION AT AN UNKNOWN PRESSURE. 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 16869410 ↗
• MalfunctionApr 27, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING PREPARATION OF THE 6.0X100MM ARMADA 18 BALLOON DILATATION CATHETER (BDC) SALINE WAS NOTED TO BE LEAKING AT THE DISTAL SHOULDER OF THE BDC WHERE IT DIPS. ANOTHER BDC WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO 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 14220529 ↗
• MalfunctionMar 30, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE CALCIFIED MID SUPERFICIAL FEMORAL ARTERY (SFA) WITH NO TORTUOSITY. BOTH ARMADA 18 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETERS RUPTURED ON THE FIRST INFLATION TO 9 ATMOSPHERES. THERE WAS NO RESISTANCE DURING ADVANCEMENT. THE DEVICES WERE PREPPED PER THE INSTRUCTIONS FOR USE (IFU). ANOTHER ARMADA PTA CATHETER WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13955533 ↗
• MalfunctionJul 2, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A CALCIFIED SUPERFICIAL FEMORAL ARTERY (SFA). THE ARMADA 18 6X100 MM PERCUTANEOUS TRANSLUMNIAL ANGIOPLASTY (PTA) CATHETER RUPTURED AFTER ONE INFLATION TO NOMINAL PRESSURE. THE DEVICE WAS REMOVED AND A NEW ARMADA 18 6X150 MM PTA CATHETER WAS USED AND AGAIN THE BALLOON RUPTURED AFTER ONE INFLATION AT NOMINAL PRESSURE. AN UNSPECIFIED BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12111684 ↗
• MalfunctionMar 11, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED, LESION IN THE SUPERFICIAL FEMORAL ARTERY. THE 6.0MM X 100MM X 150CM ARMADA 18 BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION. DURING THE FIRST INFLATION TO 14 ATMOSPHERES, THE BALLOON RUPTURED. A NEW ARMADA 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 11467849 ↗
• MalfunctionJan 5, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A TARGET LESION IN THE HEAVILY CALCIFIED RIGHT SUPERFICIAL FEMORAL ARTERY (SFA). THE DEVICE WAS ADVANCED TO THE TARGET LESION WITHOUT DIFFICULTY. DURING THE FIRST INFLATION, THE BALLOON RUPTURED AT 6 ATMOSPHERES (ATM). THERE WAS NO ADVERSE PATIENT EFFECT OR CLINICALLY SIGNIFICANT DELAY. THERE WAS NO RESISTANCE NOTED DURING WITHDRAWAL AND ALL PORTIONS OF THE DEVICE WERE REMOVED. A SECOND ARMADA DILATATION CATHETER WAS USED WITHOUT ISSUE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11121299 ↗
• MalfunctionSep 16, 2020Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA). THE 6.0X100MM ARMADA 18 BALLOON CATHETER WAS ADVANCED TO POST DILATE AN ABSOLUTE PRO STENT. PRIOR TO INFLATING THE ARMADA BDC, IT WAS OBSERVED THAT THE PROXIMAL BALLOON MARKER DID NOT ALIGN WITH THE LENGTH OF THE IMPLANTED STENT. WHEN THE ARMADA BDC WAS INFLATED, THE BALLOON SHOULDERS WERE CONFIRMED TO BE WELL WITHIN THE STENT, BUT THE PROXIMAL MARKER DID NOT ALIGN WITH THE PROXIMAL BALLOON SHOULDER. THE SAME 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 10544362 ↗
• MalfunctionSep 1, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A TARGET LESION IN THE HEAVILY CALCIFIED SUPERFICIAL FEMORAL ARTERY. ATHERECTOMY WAS PERFORMED AND THEN THE ARMADA 18 DILATATION CATHETER WAS ADVANCED TO THE TARGET LESION. THE DILATATION CATHETER BALLOON WAS INFLATED, BUT RUPTURED ON THE FIRST INFLATION AT LESS THAN RATED BURST PRESSURE, AROUND 8 ATMOSPHERES. THERE WAS NO DIFFICULTY NOTED REMOVING THE DEVICE AND NO ADVERSE PATIENT EFFECT. A SECOND ARMADA 18 WAS USED WITHOUT ISSUE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10480543 ↗
• MalfunctionAug 25, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A CHRONICALLY OCCLUDED LESION IN THE LEFT SUPERFICIAL FEMORAL ARTERY. THE ARMADA 18 WAS ADVANCED TO THE LESION AND RUPTURED DURING THE FIRST INFLATION AT 8 ATMOSPHERES. AN ARMADA 35 WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED 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 10452252 ↗
• MalfunctionAug 18, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE HEAVILY CALCIFIED LEFT SUPERFICIAL FEMORAL ARTERY (SFA). THE ARMADA 18 DILATATION CATHETER WAS ADVANCED TO THE TARGET LESION WITHOUT RESISTANCE. THE BALLOON WAS INFLATED AND RUPTURED AT 10 ATMOSPHERES (ATM) DURING THE FIRST INFLATION. THE DILATATION CATHETER WAS REMOVED WITHOUT RESISTANCE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY. A SECOND SAME DEVICE WAS USED WITHOUT ISSUE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10423151 ↗
• MalfunctionApr 22, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A HEAVILY CALCIFIED RIGHT SUPERFICIAL FEMORAL ARTERY. BOTH ARMADA 18 BALLOONS (6.0X120MM AND 6.0X100MM) RUPTURED AT 10 ATM DURING THE FIRST INFLATION. A NON-ABBOTT 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 9986649 ↗
• MalfunctionApr 13, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT THIS WAS A PROCEDURE TO TREAT A LESION WITH HEAVY CALCIFICATION AND NO TORTUOSITY IN THE RIGHT MID/DISTAL SUPERFICIAL FEMORAL ARTERY (SFA). THE 6.0 MM X 100 MM X 150 CM ARMADA 18 BALLOON CATHETER WAS ADVANCED TO THE TARGET LESION WITHOUT ISSUE FOR PRE-DILATATION. THE BALLOON WAS INFLATED TWICE SUCCESSFULLY AT 4 AND 6 ATMOSPHERE (ATM) AND WAS REMOVED INTACT. THE ARMADA 18 BALLOON CATHETER WAS ADVANCED A SECOND TIME, BUT THE BALLOON RUPTURED AT 10 ATM DURING THE 3RD INFLATION. 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 9954691 ↗
• MalfunctionMar 22, 2019Inflation Problem; Material Rupture; Inflation Problem; Material Rupture

  IT WAS REPORTED THE PROCEDURE WAS PERFORMED TO TREAT A 60% STENOSED, NON-TORTUOUS, AND NON-CALCIFIED LESION IN THE LEFT SUPERFICIAL FEMORAL ARTERY. AN ATTEMPT TO INFLATE A 6X100MM ARMADA 18 BALLOON CATHETER WAS MADE; HOWEVER, THE BALLOON DID NOT INFLATE AND A LEAK OF CONTRAST ON THE BALLOON NEAR THE SHAFT WAS NOTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH AN UNSPECIFIED 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 8445028 ↗
• MalfunctionMar 6, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING A PROCEDURE OF THE HEAVILY CALCIFIED SUPERFICIAL FEMORAL ARTERY (SFA), THREE DIFFERENT ARMADA 18 BALLOON DILATATION CATHETERS (BDC) WERE USED; EACH RUPTURED DURING THE FIRST INFLATION AT NOMINAL PRESSURE. THE PROCEDURE WAS COMPLETED USING A DIFFERENT BDC WITHOUT ISSUE. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT. 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 8394614 ↗
• MalfunctionDec 20, 2018Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA). THE 6.0X100MM OTW ARMADA 18 BALLOON CATHETER WAS ADVANCED TO THE LESION WITH RESISTANCE MET AT A PREVIOUSLY IMPLANTED STENT. DURING FIRST INFLATION, THE BALLOON RUPTURED AT 6 ATMOSPHERES (ATM) DUE TO INTERACTIONS WITH THE STENT STRUTS. THE BALLOON CATHETER WAS REMOVED WITH NO ISSUE AND REPLACED WITH A NEW BALLOON CATHETER 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 Consequences Or Impact To Patient

  MAUDE report 8184328 ↗
• MalfunctionJan 29, 2018Difficult To Position; Material Rupture

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A LESION IN THE HEAVILY CALCIFIED, HEAVILY TORTUOUS LEFT SUPERFICIAL FEMORAL ARTERY. THE 7.0MM X 100MM X135 CM ARMADA 35 BALLOON DILATATION CATHETER (BDC) WAS SUCCESSFULLY USED FOR PRE-DILATATION; HOWEVER, THE BDC WAS NOT ABLE TO RE-ADVANCE THROUGH THE NON-ABBOTT 5X6FR INTRODUCER SHEATH FOR POST DILATATION OF AN UNSPECIFIED STENT. THE ARMADA BDC WAS REMOVED FROM THE SHEATH WITHOUT ISSUE. A 6.0MM X 80MM ARMADA 18 BDC WAS SUCCESSFULLY USED FOR POST DILATATION. IT WAS NOTED THAT A LARGER BALLOON WAS NEEDED AND A 6.0MM X 100MM X150 CM ARMADA 18 BDC WAS SUCCESSFULLY USED FOR PRE-DILATATION, HOWEVER THE BDC WAS NOT ABLE TO RE-ADVANCE THROUGH THE NON-ABBOTT INTRODUCER SHEATH; THE BDC WAS REMOVED FROM THE SHEATH WITHOUT ISSUE. A 6.0MM X 80MM ARMADA 18 BDC WAS USED WITHOUT ISSUE TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. RETURNED DEVICE ANALYSIS REVEALED THE BALLOON WAS RUPTURED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7225871 ↗