Armada A2030-200Recalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 08717648156113), received between Apr 25, 2017 and Nov 17, 2025 — classified as 2 injuries, 28 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (18 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 25 most recent of 30 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 17, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED ANTERIOR TIBIAL ARTERY. THE 3.0X200MM ARMADA 14 BALLOON DILATATION CATHETER RUPTURED DURING THE FIRST INFLATION AT 8 ATMOSPHERES. A NEW ARMADA 14 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 23571183 ↗
• MalfunctionJan 21, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE SUPERFICIAL FEMORAL AND BEHIND THE KNEE ARTERIES WITH HEAVY CALCIFICATION AND HEAVY TORTUOSITY. THE LESION WAS ACCESSED WITH AN UNSPECIFIED .014 GUIDE WIRE AND THE 3X200 MM ARMADA PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER WAS ADVANCED TO THE LESION. THE BALLOON WAS INFLATED TO 8 ATMOSPHERES (ATM) WITHOUT ISSUE BUT RUPTURED AT 10 ATM. THE BALLOON WAS REMOVED AND THE 6X60 MM ABSOLUTE PRO SELF EXPANDING STENT SYSTEM (SESS) WAS ATTEMPTED TO BE ADVANCED; HOWEVER, THE DEVICE COULD NOT CROSS THE LESION DUE TO THE ANATOMY. THEREFORE, THE PATIENT WAS MEDICALLY MANAGED. 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 21200487 ↗
• MalfunctionOct 24, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO LESION IN THE ANTERIOR TIBIAL ARTERY WITH HEAVY CALCIFICATION. THE 3X200MM ARMADA 14 BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION AND THE BALLOON WAS INFLATED TO 8 ATMOSPHERES (ATM); HOWEVER, THE BALLOON RUPTURED DURING THE FIRST INFLATION. ANOTHER 3X200MM ARMADA BDC WAS THEN INFLATED TO 8 ATMOSPHERES (ATM) AT THE TARGET LESION; HOWEVER, THE SECOND BALLOON ALSO RUPTURED DURING THE FIRST INFLATION. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. ANOTHER ARMADA BALLOON WAS USED TO CONTINUE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20529545 ↗
• MalfunctionOct 24, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO LESION IN THE ANTERIOR TIBIAL ARTERY WITH HEAVY CALCIFICATION. THE 3X200MM ARMADA 14 BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION AND THE BALLOON WAS INFLATED TO 8 ATMOSPHERES (ATM); HOWEVER, THE BALLOON RUPTURED DURING THE FIRST INFLATION. ANOTHER 3X200MM ARMADA BDC WAS THEN INFLATED TO 8 ATMOSPHERES (ATM) AT THE TARGET LESION; HOWEVER, THE SECOND BALLOON ALSO RUPTURED DURING THE FIRST INFLATION. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. ANOTHER ARMADA BALLOON WAS USED TO CONTINUE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20527278 ↗
• MalfunctionJul 10, 2024Inflation Problem; Material Rupture; Inflation Problem; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE POSTERIOR TIBIAL ARTERY. THE 3.0X20MM ARMADA 14 PTA CATHETER DID NOT INFLATE. TWO INFLATIONS WERE ATTEMPTED AT 10 ATMOSPHERES, BUT THE BALLOON DID NOT INFLATE. ONCE THE CATHETER WAS REMOVED FROM THE ANATOMY, A LEAK WAS NOTED ON THE BALLOON. A NEW ARMADA 14 WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19713715 ↗
• InjuryJun 5, 2024Failure to Deflate; Failure to Deflate

  IT WAS REPORTED THAT THE 3.0X200 MM ARMADA PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER WOULD NOT DEFLATE. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE; HOWEVER IT IS LIKELY INTERVENTION WAS REQUIRED TO DEFLATE THE BALLOON. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19468406 ↗
• MalfunctionApr 1, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED, MILDLY TORTUOUS UNSPECIFIED LESION. THE 3.0X200MM ARMADA 14 DILATATION CATHETER BALLOON WAS NOT ABLE TO BE PRESSURIZED TO 8 ATMOSPHERES AS IT WAS NOTED THERE WAS A LIQUID LEAK FROM THE STRAIN RELIEF AND THE SHAFT. ANOTHER SAME SIZE DEVICE WAS USED TO 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 19014371 ↗
• MalfunctionFeb 20, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN 80% STENOSED DE NOVO LESION IN THE TIBIAL ARTERY WITH HEAVY CALCIFICATION. A 3X200MM AND A 3X120MM ARMADA BALLOON DILATATION CATHETER (BDC) WERE USED IN A PROCEDURE. HOWEVER, THE BALLOONS RUPTURED AT 8 ATMOSPHERES (ATM) DURING THE FIRST INFLATION. THERE WAS NO ADVERSE PATIENT EFFECT AND CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. ANOTHER ARMADA BALLOON WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18743589 ↗
• MalfunctionSep 15, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT WHILE FLUSHING THE GUIDEWIRE PORT DURING PREPARATION OF THE 3.0X200MM ARMADA 14 BALLOON DILATATION CATHETER (BDC) A LEAK WAS OBSERVED AT THE HUB. THE BDC WAS NOT USED IN A PROCEDURE AND THERE WAS NO PATIENT INVOLVEMENT. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17761179 ↗
• MalfunctionMay 5, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN AN UNSPECIFIED ARTERY. THE 3.0X200MM ARMADA 14 BALLOON DILATATION CATHETER (BDC) WAS LEAKING CONTRAST FROM THE HUB CONNECTING TO THE BALLOON WHICH COULD HAVE PREVENTED THE BALLOON FROM FULLY INFLATING. THERE WAS NO REPORTED 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 16877390 ↗
• MalfunctionMay 1, 2023Difficult to Remove; Difficult to Advance; Difficult to Remove; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA) WITHOUT TORTUOSITY. THE ACCESS SITE WAS THE RIGHT FEMORAL ARTERY. THE 3.0X200MM ARMADA 14 BALLOON DILATATION CATHETER (BDC) HAD RESISTANCE DURING ADVANCEMENT AND GOT STUCK ON THE GUIDE WIRE. THE GUIDE WIRE AND BALLOON WERE REMOVED AS A UNIT. ANOTHER SAME SIZE ARMADA 14 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 16844022 ↗
• MalfunctionDec 1, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LEFT POSTERIOR TIBIAL ARTERY. A 2X200MM ARMADA 14 BALLOON WAS ADVANCED WITHOUT ANY RESISTANCE TO THE TARGET LESION AND INFLATED ONCE WHEN IT RUPTURED AT 12 ATMOSPHERES (ATM). A SECOND 3X200MM ARMADA 14 BALLOON WAS ADVANCED WITHOUT RESISTANCE BUT WHEN INFLATED ONCE IT RUPTURED AT 14 ATM. A NON-ABBOTT BALLOON (CSI) 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 15898596 ↗
• MalfunctionAug 24, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED POSTERIOR TIBIAL ARTERY. THE 3.0X200MM ARMADA 14 BALLOON DILATATION CATHETER WAS ADVANCED AND DURING THE 1ST INFLATION THE BALLOON RUPTURED AT 8 ATMOSPHERES. ANOTHER 3.0X200MM ARMADA 14 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 15283706 ↗
• MalfunctionFeb 10, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED, MILDLY TORTUOUS, 99% STENOSED LESION IN THE LEFT ANTERIOR TIBIAL ARTERY. A 3X200MM ARMADA 14 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION WITHOUT ISSUE AND INFLATED ONE TIME TO 8 ATMOSPHERES (ATM) WHEN THE BALLOON RUPTURED, POSSIBLY DUE TO VESSEL CALCIFICATION. THERE WAS NO ADVERSE PATIENT EFFECT OR A CLINICALLY SIGNIFICANT DELAY IN PROCEDURE. ANOTHER DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13509996 ↗
• MalfunctionSep 13, 2021Inflation Problem; Material Rupture; Inflation Problem; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE DE NOVO, 50% STENOSED, MILDLY CALCIFIED POPLITEAL ARTERY. THE 3.0X200 MM ARMADA 14 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER WAS INFLATED ONCE TO 8 ATMOSPHERES (ATM) AND BEGAN TO LEAK CONTRAST WHEN THE CONTRAST AGENT WAS APPLIED. ADDITIONALLY, THE BALLOON COULD ONLY BE PARTIALLY INFLATED. ANOTHER, SAME SIZE ARMADA 14 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 12459884 ↗
• MalfunctionJul 12, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED DE NOVO LESION IN THE POPLITEAL ARTERY. THE 3.0X200 MM ARMADA 14 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER WAS ADVANCED TO THE LESION WITHOUT RESISTANCE. THE PTA BALLOON WAS INFLATED ONCE FOR 180 SECONDS AND THE BALLOON RUPTURED AT 8 ATMOSPHERES. ANOTHER SAME SIZE ARMADA PTA CATHETER WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO REPORTED SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12155860 ↗
• MalfunctionJun 28, 2021Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A HEAVILY CALCIFIED LESION IN THE POSTERIOR TIBIAL ARTERY. THE 3.0X200MM ARMADA 14 BALLOON CATHETER WAS ADVANCED; HOWEVER, RESISTANCE WITH THE ANATOMY WAS FELT. ADDITIONALLY, THE BALLOON RUPTURED AT 6 ATMOSPHERES DURING THE FIRST INFLATION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH AN UNSPECIFIED ARMADA 14 BALLOON CATHETER. 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 12081464 ↗
• MalfunctionFeb 16, 2021Inflation Problem; Leak/Splash; Inflation Problem; Leak/Splash

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A SUPERFICIAL FEMORAL ARTERY. A 3X200MM ARMADA BALLOON WAS PREPPED PER THE INSTRUCTIONS FOR USE. IT WAS THEN ADVANCED TO THE LESION WITHOUT RESISTANCE NOTED. THE BALLOON WAS INFLATED ONCE FOR 2 MINUTES AT 8 ATMOSPHERES WHEN IT WAS NOTED THAT THE SHAFT (GUIDE WIRE EXIT NOTCH AREA) WAS LEAKING. THE BALLOON WAS ONLY ABLE TO PARTIALLY INFLATE. THE DEVICE WAS SIMPLY REMOVED AND ANOTHER ARMADA 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 11332621 ↗
• MalfunctionSep 9, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED CHRONIC TOTALLY OCCLUDED LESION IN THE ANTERIOR TIBIAL ARTERY. REPORTEDLY, A 3.0MM/120MM ARMADA 14 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER WAS INFLATED ONCE AND RUPTURED AT 6 ATMOSPHERES (ATM). A 3.0MM/200MM ARMADA 14 PTA BALLOON CATHETER WAS INFLATED ONCE AND RUPTURED AT 4 ATM. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A SMALLER UNSPECIFIED BALLOON DILATATION CATHETER FOR PRE-DILATATION AND LASER ATHERECTOMY. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO REPORTED ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10511934 ↗
• MalfunctionApr 29, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE LEFT TIBIAL ARTERY THAT WAS HEAVILY CALCIFIED. THE LESION WAS PRE-DILATED WITH A 2.0 BALLOON FIRST. THEN, DURING THE FIRST INFLATION OF THE ARMADA 14 , THE BALLOON RUPTURED AT 8-10 ATMOSPHERES. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. A NON-ABBOTT BALLOON WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10011974 ↗
• MalfunctionMar 10, 2020Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT THE POPLITEAL ARTERY. DURING RETRIEVAL, THE 3.0X200MM ARMADA 14 BALLOON DILATATION CATHETER AND THE COMMAND ES 14 GUIDEWIRE BECAME STUCK WITH EACH OTHER AND THEY HAD TO BE REMOVED AS A SINGLE UNTIL. A NEW UNSPECIFIED BALLOON AND GUIDE WIRE WERE USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9813911 ↗
• MalfunctionJan 28, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A NON-TORTUOUS, MILDLY CALCIFIED POSTERIOR TIBIAL ARTERY. DURING INFLATION OF THE 3.0X200MM ARMADA 14 BALLOON DILATATION CATHETER, THE DEVICE WOULD NOT HOLD PRESSURE AS FLUID LEAKED FROM THE HUB. THE DEVICE WAS REPLACED WITH A NEW UNSPECIFIED BALLOON 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 9638922 ↗
• MalfunctionAug 27, 2019Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A CALCIFIED LESION IN THE RIGHT SUPERFICIAL FEMORAL ARTERY. FOLLOWING ATHERECTOMY AND BALLOON ANGIOPLASTY WITH UNSPECIFIED BALLOON CATHETERS, A 3.0 X 200 MM ARMADA 14 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER WAS ADVANCED TO THE LESION WITH NO REPORTED RESISTANCE. THE BALLOON OF THE PTA BALLOON CATHETER WAS INFLATED ONCE TO NOMINAL PRESSURE; HOWEVER, FAILED TO DEFLATE. THE UNSPECIFIED INDEFLATOR WAS SWITCHED TO A SYRINGE AND THE BALLOON WAS FULLY DEFLATED. ON REMOVAL OF THE BALLOON WITH NO REPORTED RESISTANCE, A FURTHER INFLATION WAS MADE AT THE PROXIMAL LESION. WHILE THERE WAS NO REPORTED ISSUE WITH INFLATION, THE BALLOON FAILED TO DEFLATE AGAIN. THE BALLOON WAS SUCCESSFULLY DEFLATED WITH THE USE OF A SYRINGE. THE PTA BALLOON CATHETER WAS REMOVED AND NO FURTHER INTERVENTION WAS REPORTED. 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 8936594 ↗
• MalfunctionSep 7, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE ARMADA PERIPHERAL DILATATION CATHETER WAS ADVANCED TO AN UNSPECIFIED LESION WITHOUT ISSUE. BALLOON INFLATION WAS PERFORMED, HOWEVER, THE BALLOON RUPTURED BELOW RATED BURST PRESSURE. THE DEVICE WAS REMOVED WITHOUT ISSUE. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7855978 ↗
• MalfunctionMay 14, 2018Deflation Problem; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THE PROCEDURE WAS PERFORMED TO TREAT A LESION WITH HEAVY CALCIFICATION IN THE DISTAL POSTERIOR TIBIAL ARTERY. THE ARMADA 14 BALLOON CATHETER WAS ADVANCED TO THE TARGET LESION SUCCESSFULLY. DURING INFLATION, THE PHYSICIAN COULD NOT SEE THE BALLOON VERY WELL; THEREFORE, CONTRAST WAS CHANGED TO 100% FOR VISIBILITY. THE BALLOON WAS INFLATED MULTIPLE TIMES SUCCESSFULLY TO 10 ATMOSPHERES. HOWEVER, DURING DEFLATION THE BALLOON HAD DIFFICULTIES DEFLATING AND TOOK A LONG TIME TO DEFLATE. THE BALLOON EVENTUALLY DEFLATED COMPLETELY AND WAS REMOVED WITHOUT ISSUE. 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 7511683 ↗