Armada B1050-080Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 08717648154621), received between Oct 17, 2016 and Dec 15, 2025 — classified as 1 injury, 15 malfunctions.

The most frequently reported specific device problem is “Deflation Problem” (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. How this data works · Data updated Oct 13, 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.

• MalfunctionDec 15, 2025Leak/Splash; Material Rupture; Leak/Splash; Material Rupture

  SUBSEQUENT TO THE INITIAL REPORT BEING FILED, THE ACCOUNT HAS CONFIRMED THAT THE REPORTED RUPTURE WAS A LEAK, DISTAL OF THE 5X80MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) STRAIN RELIEF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23804944 ↗
• MalfunctionDec 9, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A RESTENOSED, HEAVILY CALCIFIED, HEAVILY TORTUOUS POPLITEAL ARTERY THAT IS 80% STENOSED. THE 5.0X80MM ARMADA 35 BALLOON DILATATION CATHETER RUPTURED AT 16 ATMOSPHERES DURING THE FIRST INFLATION. A NEW ARMADA 35 BDC 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 23760353 ↗
• MalfunctionDec 2, 2025Material Rupture; Improper or Incorrect Procedure or Method; Material Rupture; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A MILDLY CALCIFIED LESION IN THE LEFT SUPERFICIAL FEMORAL ARTERY. THE 5.0X80MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION AND THE BALLOON PREPPED FOR USE. WHEN THE BALLOON WAS INFLATED, IT WAS NOTED TO BE LEAKING CONTRAST AND NOT HOLDING PRESSURE. THE BDC WAS REMOVED AND THE PROCEDURE COMPLETED USING ANOTHER BALLOON. 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 23691669 ↗
• MalfunctionMar 14, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING PREPARATION OF THE 5.0X80MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) DURING ATTEMPTED ASPIRATION, CONTINUOUS BUBBLES WERE NOTED COMING INTO THE INFLATION DEVICE. THE BDC WAS NOT USED AND REPLACED WITH ANOTHER BALLOON CATHETER TO 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 21605973 ↗
• MalfunctionOct 9, 2024Break; Inflation Problem; Break; Inflation Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE URETER. THE 5X80 MM ARMADA PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER DID NOT EXPAND DUE TO A BREAK. THERE WERE NO ADVERSE PATIENT EFFECTS. A NEW BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20408816 ↗
• MalfunctionAug 15, 2024Inflation Problem; Leak/Splash; Inflation Problem; Leak/Splash

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN AN UNSPECIFIED ARTERY. THE 5X80MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) WAS ADVANCE TO THE TARGET LESION; HOWEVER, THE BALLOON FAILED TO INFLATE AFTER SEVERAL ATTEMPTS. THE BDC WAS REMOVED FROM THE PATIENT. OUTSIDE OF THE PATIENT ANOTHER ATTEMPT WAS MADE TO INFLATE THE BALLOON AND PRESSURE WAS APPLIED TO 24 ATMOSPHERES (ATM); HOWEVER, THE BALLOON STILL DID NOT INFLATE. ANOTHER ARMADA BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. RETURN DEVICE ANALYSIS FOUND THERE WAS A LEAK NOTED AT 6ATM AT THE PROXIMAL END OF HUB AT GUIDE WIRE PORT. BUBBLES WERE NOTED IN THE GUIDE WIRE PORT WHEN INDEFLATOR WAS PRESSURIZED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19996182 ↗
• InjuryDec 22, 2022Material Separation; Failure to Advance; Material Separation; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED, HEAVILY TORTUOUS LEFT ILIAC ARTERY. DURING ADVANCEMENT OF THE 5.0X80MM ARMANDA 35 BALLOON DILATATION CATHETER (BDC) RESISTANCE WAS NOTED WITH ANATOMY WHEN CROSSING OVER INTO THE AORTA. PART OF THE ACTUAL BALLOON SEPARATED. THE SEPARATED PORTION WAS ATTEMPTED TO BE SNARED SEVERAL TIMES; HOWEVER, IT WAS UNSUCCESSFUL. THE SEPARATED PORTION REMAINS IN THE PATIENT ,BUT WAS NOTED TO BE DOING WELL. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 16033608 ↗
• MalfunctionApr 24, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING PREP, A 5X80MM ARMADA 35 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER DID NOT HOLD PRESSURE AND LEAKED AIR AS BUBBLES WERE NOTED. THE DEVICE WAS NOT USED AND THERE WAS NO PATIENT INVOLVEMENT. A SAME SIZED ARMADA 35 PTA 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 11721620 ↗
• MalfunctionMay 4, 2018Deflation Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN AN ARTERIOVENOUS SHUNT WITH MODERATE CALCIFICATION. A 5.0 X 80 MM ARMADA BALLOON CATHETER WAS INFLATED TWO TIMES AT 14 ATMOSPHERES, WHEN IT PARTIALLY DEFLATED. THE BALLOON CATHETER WAS REMOVED FROM THE INTRODUCER SHEATH AND THE PROCEDURE WAS COMPLETED USING 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 7487807 ↗
• MalfunctionFeb 15, 2018Deflation Problem; Difficult to Remove

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT AN ARTERIOVENOUS SHUNT. THE 5X80 ARMADA 35 BALLOON DILATATION CATHETER WAS INFLATED ONCE HOWEVER WOULD NOT FULLY DEFLATE AFTER NEGATIVE WAS PULLED FOR OVER 10 SECONDS. THE BALLOON WAS ABLE TO PARTIALLY DEFLATE AFTER MULTIPLE ATTEMPTS. RESISTANCE WAS MET REMOVING THE DEVICE FROM THE ANATOMY. 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 7273964 ↗
• MalfunctionJan 25, 2018Leak/Splash

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN 80% STENOSED, MILDLY TORTUOUS, AND MILDLY CALCIFIED LESION IN THE MID INTERNAL CAROTID ARTERY. AN ATTEMPT TO INFLATE A 5X80MM ARMADA 35 BALLOON CATHETER WAS MADE; HOWEVER, A LEAK AT THE BALLOON CATHETER JUNCTION WAS NOTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH AN UNKNOWN BALLOON DILATATION CATHETER. 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 7219936 ↗
• MalfunctionOct 30, 2017Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE MID-FEMORAL ARTERY. WHEN THE ARMADA 35 5MM/80MM PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CATHETER WAS INFLATED, THE BALLOON RUPTURED AT 18 ATMOSPHERES AFTER THE SECOND INFLATION. A HIGH-PRESSURE BALLOON WAS USED TO COMPLETE THE PROCEDURE. THE DEVICE WAS PREPPED ACCORDING TO THE DIRECTIONS FOR USE WITH NO ISSUES NOTED. 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 6988827 ↗
• MalfunctionSep 20, 2017Inflation Problem

  IT WAS REPORTED THAT DURING A PROCEDURE OF THE CHRONIC TOTALLY OCCLUDED, HEAVILY CALCIFIED, MID POPLITEAL ARTERY, THE ARMADA 35 BALLOON DILATATION CATHETER (BDC) COULD NOT DILATE THE VESSEL AFTER TWO INFLATION ATTEMPTS TO RATED BURST PRESSURE (RBP). THE BALLOON DID NOT APPEAR FULLY INFLATED AND WASTING WAS NOTED ON ANGIOGRAPHY. THE DEVICE WAS REMOVED AND A NON-ABBOTT BDC WAS USED IN THE PROCEDURE. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA OR A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6880197 ↗
• MalfunctionDec 1, 2016Deflation Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE PROXIMAL POPLITEAL ARTERY. RESISTANCE WAS NOT FELT DURING ADVANCEMENT OF THE 5 X 80 MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) THROUGH THE LESION AND IT CROSSED SUCCESSFULLY. THE BDC WAS INFLATED ONCE TO NOMINAL PRESSURE; HOWEVER, IT FAILED TO DEFLATE AFTER SEVERAL DEFLATION ATTEMPTS. A 50 ML SYRINGE WAS USED TO PULL NEGATIVE PRESSURE FOR 10 MINUTES TO FULLY DEFLATE THE BALLOON AND THE BALLOON WAS REMOVED FROM THE ANATOMY. A REPLACEMENT BDC 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 6138733 ↗
• MalfunctionNov 1, 2016Deflation Problem; Difficult to Remove

  IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL INTERVENTION PROCEDURE TO TREAT A 75% STENOSED LESION IN THE NON-TORTUOUS PROXIMAL SUPERFICIAL FEMORAL ARTERY (SFA), A 5.0 MM X 80 MM X 80 CM ARMADA 35 LL BALLOON DILATATION CATHETER (BDC) WAS ADVANCED AND INFLATED WITHOUT DIFFICULTY, COMPLETING DILATATION. WHEN ATTEMPTING TO DEFLATE THE BALLOON, IT WAS DIFFICULT TO DEFLATE AND WAS CONSEQUENTLY DIFFICULT TO REMOVE FROM THE VESSEL. THE BALLOON WAS ABLE TO BE COMPLETELY DEFLATED AFTER MULTIPLE DEFLATION ATTEMPTS AND SEVERAL MINUTES OF ASPIRATION USING THE SAME INFLATION DEVICE. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO OCCURRENCE OF A CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6071506 ↗
• MalfunctionOct 17, 2016Deflation Problem

  IT WAS REPORTED THAT A 5.0 MM X 80 MM X 80 CM ARMADA 35 BALLOON DILATATION CATHETER (BDC) WAS PREPPED AND ADVANCED WITHOUT ISSUE TO AN UNSPECIFIED DEPLOYED STENT IN THE MODERATELY CALCIFIED, MODERATELY TORTUOUS LEFT SUPERFICIAL FEMORAL ARTERY (SFA) TO POST-DILATE THE STENT. THE ARMADA 35 BALLOON WAS INFLATED WITHOUT ISSUE AND POST-DILATATION WAS COMPLETED. WHEN ATTEMPTING TO DEFLATE THE BALLOON, THE UNSPECIFIED INFLATION DEVICE SHOWED NEGATIVE PRESSURE, BUT THE BALLOON DID NOT DEFLATE AT ALL. THE INFLATION DEVICE WAS SWAPPED OUT FOR A SYRINGE AND, THOUGH MUCH FORCE WAS REQUIRED TO PULL NEGATIVE PRESSURE USING THE SYRINGE, THE BALLOON SLIGHTLY DEFLATED, BUT WAS DIFFICULT TO WITHDRAW FROM THE STENT AND VESSEL. THE PARTIALLY DEFLATED ARMADA 35 WAS ABLE TO BE WITHDRAWN AGAINST RESISTANCE INTO THE GUIDING CATHETER. UPON RETRACTION INTO THE GUIDING CATHETER, THE ARMADA 35 BALLOON PARTIALLY DEFLATED SOME MORE AS IT ENTERED THE DISTAL TIP OF THE GUIDING CATHETER AND WAS ABLE TO BE COMPLETELY RETRACTED THROUGH THE GUIDING CATHETER WITHOUT ANY RESISTANCE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO OCCURRENCE OF A CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6034385 ↗