Armada B2050-150Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 08717648155222), received between Apr 18, 2017 and Oct 2, 2025 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (6 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 2, 2025Inflation Problem; Leak/Splash; Inflation Problem; Leak/Splash

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN AN UNSPECIFIED ARTERY. DURING PREPARATION OF THE 5X150MM ARMADA 35 BALLOON DILATATION CATHETER (BDC), AIR ASPIRATION WAS NOT ABLE TO BE COMPLETED USING THE UNSPECIFIED INFLATION DEVICE. THEREFORE, ANOTHER INFLATION DEVICE WAS ATTEMPTED TO BE USED FOR AIR ASPIRATION, BUT THE SECOND INFLATION DEVICE ALSO WAS NOT ABLE TO CREATE SUCTION TO PREPARE THE BALLOON. THE PHYSICIAN MANUALLY PREPARED THE BALLOON WITH CONTRAST AND ATTACHED THE INFLATION DEVICE TO USE THE BDC IN THE PROCEDURE. THE BDC WAS ADVANCED TO THE TARGET LESION AND AN ATTEMPT WAS MADE TO INFLATE THE BALLOON; HOWEVER, A CONTRAST LEAK WAS NOTED THE CONNECTION POINT OF THE BALLOON CATHETER AND HUB. THEREFORE, THE BDC WAS REMOVED FROM THE PATIENT. THERE WAS NO ADVERSE PATIENT EFFECT REPORTED AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23203771 ↗
• MalfunctionJun 9, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE 5X150MM ARMADA BALLOON DILATATION CATHETER (BDC) WAS USED IN THE PROCEDURE; HOWEVER, LEAKAGE WAS NOTED UPON INSERTION OF THE BDC. THERE WAS NO ADVERSE PATIENT EFFECT REPORTED AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22169563 ↗
• MalfunctionOct 21, 2024Material Rupture; Improper or Incorrect Procedure or Method; Material Split, Cut or Torn; Material Rupture; Improper or Incorrect Procedure or Method; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN AN UNSPECIFIED ARTERY. THE 5X150MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) WAS OBSERVED THAT THE BALLOON WAS PUNCTURED DURING INITIAL PREPARATION. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20500257 ↗
• MalfunctionAug 14, 2024Inflation Problem; Leak/Splash; Improper or Incorrect Procedure or Method; Inflation Problem; Leak/Splash; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE SUPERFICIAL FEMORAL ARTERY (SFA) WITH MILD CALCIFICATION, MODERATE TORTUOSITY AND 80% STENOSIS. THE 5X150 MM ARMADA 35 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER WAS NOT PREPPED (AIR ASPIRATED) PRIOR TO USE. THE DEVICE WAS ATTEMPTED TO BE INFLATED BUT FAILED AND A LEAK AT THE HUB WAS NOTED. ANOTHER 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 19986420 ↗
• MalfunctionAug 5, 2024Inflation Problem; Material Rupture; Inflation Problem; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A MODERATELY CALCIFIED AND MILDLY TORTUOUS LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA). REPORTEDLY DURING ANGIOPLASTY A 5X150MM ON 135CM ARMADA 35 BALLOON DILATATION CATHETER (BDC) WAS USED; HOWEVER DID NO INFLATE. THE DEVICE WAS REMOVED AND 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 19906366 ↗
• MalfunctionJul 24, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE RIGHT COMMON FEMORAL ARTERY WITH HEAVY CALCIFICATION. THE 5X150 MM ARMADA 35 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER WAS ATTEMPTED TO BE INFLATED ONCE BUT IT WAS NOTED TO BE PUNCTURED AROUND 8 ATMOSPHERES. 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 19818663 ↗
• MalfunctionJan 17, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING PREPARATION OF THE 5.0X150MM ARMADA 35 BALLOON DILATATION CATHETER, IT COULD NOT MAINTAIN NEGATIVE PRESSURE. A SHORTER BALLOON WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18528553 ↗
• MalfunctionNov 14, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE MID RIGHT SUPERFICIAL FEMORAL ARTERY THAT WAS NON TORTUOUS, HEAVILY CALCIFIED AND 80% STENOSED. THE VESSEL WAS DIAMONDBACK AS WELL. REPORTEDLY, THE 5.0X150MM ARMADA BALLOON RUPTURED BETWEEN 5-7 ATMOSPHERES [NOMINAL PRESSURE WAS NOT REACHED] DURING THE FIRST INFLATION; BLOOD AND LOSS OF INDEFLATOR PRESSURE WAS NOTICED. ANOTHER SHORTER UNSPECIFIED BALLOON WAS USED TO CONTINUE 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 18136418 ↗
• MalfunctionNov 3, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE HEAVILY CALCIFIED, MODERATELY TORTUOUS SUPERFICIAL FEMORAL ARTERY (SFA) WITH 90% STENOSIS. THE 5X150 MM ARMADA 35 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER WAS PREPARED PER THE INSTRUCTIONS FOR USE AND AND WAS ADVANCED WITHOUT RESISTANCE. THE CATHETER WAS INFLATED TO NOMINAL PRESSURE AND RUPTURED. A NEW 5X200 ARMADA 35 PTA CATHETER WAS USED SUCCESSFULLY AND A SUPERA STENT WAS IMPLANTED TO COMPLETE THE PROCEDURE. THERE WERE NO 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 15723255 ↗
• MalfunctionDec 18, 2020Stretched; Difficult to Advance; Stretched; Difficult to Advance

  IT WAS REPORTED THAT THIS WAS A PROCEDURE TO TREAT A HIGHLY STENOSED RIGHT POPLITEAL ARTERY. THE ARMADA 35 BALLOON CATHETER WAS INSERTED AND ATTEMPTED TO BE ADVANCED. HOWEVER, DURING ADVANCEMENT, THE SHAFT BECAME STRETCHED. THE PHYSICIAN DECIDED TO REMOVE THE DEVICE AND REPLACE IT. IT WAS NOTED THAT THERE WERE NO ISSUES DURING REMOVAL. NO ADVERSE PATIENT EFFECTS OCCURRED AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11039772 ↗
• MalfunctionMay 9, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A HEAVILY CALCIFIED LESION IN THE SUPERFICIAL FEMORAL ARTERY. A 5X150MM ARMADA 35 BALLOON CATHETER WAS PREPARED PER THE INSTRUCTIONS FOR USE. THE BALLOON CATHETER WAS ADVANCED TO THE LESION WITHOUT RESISTANCE; HOWEVER, THE BALLOON RUPTURED DURING THE FIRST INFLATION AT 12 ATMOSPHERES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A 5X120MM ARMADA 35 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 8597181 ↗
• MalfunctionApr 27, 2017Inflation Problem; Leak/Splash

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY CALCIFIED, DE NOVO LESION IN THE NON-TORTUOUS RIGHT SUPERFICIAL FEMORAL ARTERY (SFA). A 5.0MM X 150MM X 135CM ARMADA 35 BALLOON DILATATION CATHETER (BDC) WAS PREPPED WITHOUT ISSUE AND ADVANCED TO THE LESION WITHOUT RESISTANCE. WHEN ATTEMPTING TO INFLATE THE BALLOON, THE DEVICE WOULD NOT HOLD PRESSURE AND LEAKING OF CONTRAST WAS NOTED TO BE COMING FROM THE STRAIN RELIEF AREA OF THE SHAFT THAT CONNECTS TO THE PROXIMAL HUB. THE PARTIALLY INFLATED BALLOON WAS ABLE TO BE DEFLATED WITHOUT DIFFICULTY AND WAS WITHDRAWN WITHOUT RESISTANCE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO OCCURRENCE OF A CLINICALLY SIGNIFICANT DELAY. A LARGER UNSPECIFIED 6.0MM ARMADA BDC WAS USED TO SUCCESSFULLY COMPLETE DILATATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6528629 ↗
• MalfunctionApr 18, 2017Inflation Problem; Leak/Splash

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A VESSEL LESION LOCATED IN THE SUPERFICIAL FEMORAL ARTERY (SFA). RESISTANCE WAS NOT FELT DURING THE ADVANCEMENT OF A 5.0 X 150 MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) TO THE LESION FOR PRE-DILATATION AND IT CROSSED SUCCESSFULLY; HOWEVER, THE BALLOON WOULD NOT COMPLETELY EXPAND WHEN INFLATED TO THE NOMINAL PRESSURE. A LEAK WAS OBSERVED FROM THE HUB. THE ARMADA WAS REMOVED AND A NEW 3 X 120 MM ARMADA 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 6502062 ↗