Armada 1013469-200Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 08717648208355), received between Nov 10, 2017 and Nov 1, 2023 — classified as 1 injury, 8 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (5 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.

• MalfunctionNov 1, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT TWO 5.5X100MM AND 5.5X200MM ARMADA 18 BALLOON DILATATION CATHETER RUPTURED BOTH AT 10 ATMOSPHERES DURING THE FIRST INFLATION. AN UNSPECIFIED HIGH PRESSURE BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECTS REPORTED AND NO CLINICALLY SIGNIFICANT DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18048609 ↗
• MalfunctionOct 26, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A CHRONIC TOTAL OCCLUDED LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA). THE 5.5X200MM ARMADA 18 BALLOON DILATATION CATHETER (BDC) WAS ADVANCED WITHOUT RESISTANCE AND INFLATED TWICE AT 8 ATMOSPHERES (ATMS) AND 12 ATMS BUT RUPTURED DURING THE SECOND INFLATION. ANOTHER 6X150MM ARMADA 18 BDC WAS USED TO TREAT THE SFA. HOWEVER, THE SAME ARMADA 18 BDC WAS USED TO TREAT ANOTHER LESION IN THE POPLITEAL ARTERY WITH HEAVY CALCIFICATION AND RUPTURED AT 8 ATMS DURING THE FIRST INFLATION. THERE WAS NO RESISTANCE DURING ADVANCEMENT. ANOTHER ARMADA 18 BDC WAS USED TO TREAT THE POPLITEAL ARTERY AND COMPLETED THE PROCEDURE. ALL DEVICES WERE PREPPED AND USED PER THE INSTRUCTIONS FOR USE (IFU). 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 15673209 ↗
• MalfunctionJun 15, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE HEAVILY CALCIFIED, NON-TORTUOUS, 70% STENOSED SUPERFICIAL FEMORAL ARTERY. A 6X200MM, 3X80MM, & 5.5X200MM ARMADA 18 AS WELL AS A 3X40MM & 4X60MM PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON CATHETERS (PTA) WERE ALL ADVANCED, AND THE BALLOONS RUPTURED AT 14 ATMOSPHERES IN THAT ORDER. A NON-ABBOTT BALLOON AND TWO UNSPECIFIED STENTS WERE 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 10154057 ↗
• InjuryJul 16, 2019Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LEFT SUPERFICIAL FEMORAL ARTERY. A 5.5X200MM ARMADA 18 OTW (OVER THE WIRE) BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE LESION WITHOUT ISSUE AND INFLATED ONCE AT NOMINAL PRESSURE. DURING REMOVAL, THE BDC FAILED TO DEFLATE, SEVERAL ATTEMPTS WERE PERFORMED BUT UNSUCCESSFUL. AFTER 10 MINUTES OF EFFORTS, THE BALLOON WAS ABLE TO SUCCESSFULLY DEFLATE. IT WAS THEN NOTED THAT A CLOT FORMATION ON THE LOWER LEG WAS FORMED. AN ATHERECTOMY CATHETER WAS USED TO SUCK THE CLOT OUT. RESIDUAL CLOT PERSISTED AND TISSUE PLASMINOGEN ACTIVATOR MEDICATION WAS PROVIDED TO RESOLVE THE ISSUE. HOSPITALIZATION WAS PROLONGED DUE TO THIS ISSUE. THE PATIENT IS FINE. THERE WAS NO ADVERSE PATIENT SEQUELA REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Thrombosis

  MAUDE report 8795930 ↗
• MalfunctionJun 20, 2019Leak/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 WITH MILD CALCIFICATION IN THE SUPERFICIAL FEMORAL ARTERY (SFA). DURING PREPARATION OF THE 5.5 X 200 MM ARMADA 18 BALLOON CATHETER, SOME AIR BUBBLES WERE OBSERVED, BUT THE ARMADA 18 WAS ADVANCED IN THE VESSEL. WHEN THE BALLOON WAS PRESSURIZED TO NOMINAL PRESSURE A LEAK WAS OBSERVED AT THE HUB. THE BALLOON CATHETER WAS REMOVED AND EXCHANGED FOR A NEW ARMADA 18 TO COMPLETE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT EFFECT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8718109 ↗
• MalfunctionSep 4, 2018Leak/Splash; Improper or Incorrect Procedure or Method; Leak/Splash; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE SUPERFICIAL FEMORAL ARTERY WITH NO TORTUOSITY AND NO CALCIFICATION. ON THE SECOND BALLOON INFLATION TO 4 ATMOSPHERES, A LEAK IN THE HUB OF A 5.5 X 200 MM ARMADA 18 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER WAS NOTED. THE PTA BALLOON CATHETER WAS CONTINUED TO BE USED TO COMPLETE THE SECOND INFLATION AT 4 ATMOSPHERES FOLLOWING THE IDENTIFICATION OF THE LEAK. NO FURTHER INFLATIONS WERE PERFORMED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE DEPLOYMENT OF AN UNSPECIFIED STENT. THERE WAS 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 7843938 ↗
• MalfunctionApr 26, 2018Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 60% STENOSED AND CALCIFIED LESION IN THE SUPERFICIAL FEMORAL ARTERY. A 5.5X200MM ARMADA 18 BALLOON CATHETER RUPTURED DURING THE FIRST INFLATION AT 6 ATMOSPHERES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH AN UNSPECIFIED BALLOON. 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 7467144 ↗
• MalfunctionDec 5, 2017Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE POPLITEAL TO SUPERFICIAL FEMORAL ARTERY. THE ARTERY WAS HEAVILY CALCIFIED. THE 6.0 X 200 MM ARMADA 18 BALLOON CATHETER WAS ADVANCED TO THE LESION, WITHOUT RESISTANCE FELT, AND INFLATED ONE TIME TO 8 ATMOSPHERES AT WHICH TIME THE BALLOON RUPTURED. THE 5.5 X 200 MM ARMADA 18 BALLOON CATHETER WAS ADVANCED, AGAIN WITHOUT RESISTANCE FELT, AND INFLATED ONE TIME TO 8 ATMOSPHERES WHEN IT ALSO RUPTURED. IT WAS STATED THAT THE BALLOON RUPTURES WERE DUE TO THE HEAVILY CALCIFIED ARTERY. THE BALLOON INFLATIONS WERE DETERMINED TO BE SUFFICIENT; THEREFORE, THE PROCEDURE CONTINUED ON SUCCESSFULLY WITH THE PLACEMENT OF A STENT FOR TREATMENT. NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7084103 ↗
• MalfunctionNov 10, 2017Leak/Splash

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A SUPERFICIAL FEMORAL ARTERY. THE 5.5 X 200 MM ARMADA 18 WAS ADVANCED TO THE LESION AND WAS PRESSURIZED WHEN A LEAK WAS NOTICED AT THE HUB. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH AN UNSPECIFIED BALLOON CATHETER. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7021036 ↗