Armada A2025-200Recalls & reported problems

Summary

The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 08717648156052), received between Aug 17, 2016 and May 28, 2026 — classified as 2 injuries, 33 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (16 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 35 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 28, 2026Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE LEFT POSTERIOR TIBIAL ARTERY. THE 2.5X200 MM ARMADA 14 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER WAS INFLATED ONCE AND RUPTURED AT 12 ATMOSPHERES. A 2.5X80 MM ARMADA WAS USED WITHOUT ISSUE TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25316742 ↗
• MalfunctionMay 6, 2026Break

  IT WAS REPORTED THAT DURING PREPARATION OF THE 2.50X200MM ARMADA 14 BALLOON DILATATION CATHETER (BDC), THE SHAFT WAS NOTED TO BE CRACKED/FRACTURED. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DEVICE USE OR 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 25095561 ↗
• MalfunctionNov 12, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE PERONEAL ARTERY WITH HEAVY CALCIFICATION AND 85% STENOSIS. THE 2.5X200 MM ARMADA 14 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER RUPTURED DURING THE FIRST INFLATION TO 12 ATMOSPHERES. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. AN ARMADA 14 WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23535567 ↗
• MalfunctionJun 18, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A LESION IN THE ANTERIOR TIBIAL ARTERY. THE 2.50X200MM ARMADA 14 BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION HOWEVER DURING THE FIRST INFLATION TO 4 ATMOSPHERES, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND A BALLOON RUPTURE WAS CONFIRMED. A NEW 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 22282914 ↗
• MalfunctionJan 2, 2025Deflation Problem; Improper or Incorrect Procedure or Method; Deflation Problem; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE TIBIOPERONEAL TRUNK WITH CALCIFICATION. THE 2.5X200 MM ARMADA PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER DID NOT FULLY DEFLATE AFTER USE. THE CONTRAST MIX WAS 1/3 SALINE, 1/3 CONTRAST AND THE BALLOON WAS INFLATED TO NOMINAL PRESSURE. THE DEVICE WAS WITHDRAWN INFLATED. 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 21057007 ↗
• InjuryNov 22, 2024Improper or Incorrect Procedure or Method; Failure to Deflate; Improper or Incorrect Procedure or Method; Failure to Deflate

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE RIGHT POSTERIOR TIBIAL ARTERY WITH 100% STENOSIS. THE RIGHT POPLITEAL ARTERY WAS RECANALIZED WITH AN UNSPECIFIED .035 GUIDE WIRE AND THEN A 5X150 MM ARMADA 35 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER WAS INFLATED TO NOMINAL PRESSURE FOR 120 SECONDS WITH RESTORATION OF ANTEGRADE BLOOD FLOW. THEN, RECANALIZATION OF THE OCCLUSION OF THE POSTERIOR TIBIAL ARTERY WAS PERFORMED WITH A COMMAND 14 GUIDE WIRE AND THEN THE 2.5X200 MM ARMADA 14 PTA CATHETER WAS INFLATED AND ANGIOPLASTY PERFORMED ALONG THE ENTIRE LENGTH OF THE LESION. THE ARMADA 14 PTA CATHETER WAS INFLATED 3 TIMES (10 ATM, 14 ATM AND 20 ATM); HOWEVER, THE BALLOON COULD NOT BE DEFLATED. NEGATIVE PRESSURE WAS HELD FOR 30 SECONDS AND THERE WERE MULTIPLE ATTEMPTS TO DEFLATE THE BALLOON WITHOUT SUCCESS. THE BALLOON WAS PUNCTURED WITH AN ADDITIONAL COMMAND 14 GUIDE WIRE AND THE BALLOON WAS DEFLATED AND REMOVED. FURTHER BALLOON ANGIOPLASTY WAS PERFORMED WITH ANOTHER 2.5X200 MM ARMADA 14 PTA CATHETER. THERE WERE NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20759610 ↗
• MalfunctionAug 14, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A CHRONIC TOTAL OCCLUSION OF THE PERONEAL ARTERY WITH HEAVY CALCIFICATION AND MODERATE TORTUOSITY. THE 2.5X200MM ARMADA 14 BALLOON DILATATION CATHETER (BDC) WAS USED OVER A HI-TORQUE (HT) COMMAND 14 GUIDE WIRE AND TO ENSURE THE WIRE WAS ADVANCING INTRALUMINALLY, THE GUIDE WIRE WAS REMOVED AND THE BALLOON WAS INJECTED WITH CONTRAST. UPON INFLATING THE BALLOON, A LEAK AT THE HUB WAS NOTED WITH THE PRESSURE DECLINING. AN ARMADA 18 BALLOON WAS USED TO COMPLETE THE PROCEDURE. 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 19986549 ↗
• MalfunctionMay 9, 2024Inflation Problem; Leak/Splash; Inflation Problem; Leak/Splash

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED, MODERATELY TORTUOUS ANTERIOR TIBIAL ARTERY THAT IS 99% STENOSED. THE 2.5X200MM ARMADA 14 BALLOON DILATATION CATHETER WAS ADVANCED AND ONCE INFLATING THE BALLOON IT WAS NOTED THAT THE BALLOON PARTIALLY INFLATED AS THERE AS A LEAK NOTED AT THE HUB. THEREFORE, IT WAS REMOVED AND ANOTHER 2.5X120MM ARMADA 14 BALLOON WAS USED TO CONTINUE 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 19281821 ↗
• MalfunctionJan 27, 2024Difficult to Remove; Difficult to Advance; Difficult to Remove; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE POSTERIOR TIBIAL ARTERY WITH 100% STENOSIS. THE 2.5X200MM ARMADA 14 BALLOON DILATATION CATHETER (BDC) WAS BEING ADVANCED ON THE COMMAND ES GUIDE WIRE WHEN THE ARMADA BECAME STUCK ON THE WIRE AND COULD NOT BE SIMPLY REMOVED FROM THE COMMAND GUIDE WIRE. THE ARMADA AND THE COMMAND GUIDE WIRE HAD TO BE REMOVED AS A SINGLE UNIT. A NEW SAME SIZE ARMADA AND COMMAND GUIDE WIRE WERE USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT AND THERE WAS NO CLINICALLY SIGNIFICANT DELAYS IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18592762 ↗
• MalfunctionDec 19, 2023Leak/Splash; Material Split, Cut or Torn; Leak/Splash; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING PREPARATION, AND BEFORE USE IN THE PATIENT, WHEN NEGATIVE WAS PULLED ON THE ARMADA 14 BALLOON, THERE WAS A HOLE [TEAR] IN THE BALLOON AND AIR BUBBLES CONTINUED TO FILL. A NEW ARMADA WAS USED TO CONTINUE THE PROCEDURE WITHOUT FURTHER ISSUE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18360558 ↗
• MalfunctionDec 8, 2023Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 70% STENOSED LESION IN THE ANTERIOR TIBIAL ARTERY. THE 2.5X200MM ARMADA BALLOON DILATATION CATHETER (BDC) WAS USED IN THE PROCEDURE; HOWEVER, THE LUER CONNECTION BETWEEN THE BDC AND THE INFLATION DEVICE WAS NOT ALIGNING PROPERLY. THERE WAS A LEAK FROM THE HUB AND THE ARMADA BALLOON WOULD ONLY HOLD PRESSURE BY FIRMLY HOLDING THE INFLATION DEVICE ONTO THE BDC HUB DURING INFLATION. THE SAME INFLATION DEVICE WAS USED WITH OTHER BALLOONS IN THE PROCEDURE WITHOUT ANY ISSUES. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18297587 ↗
• MalfunctionAug 31, 2023Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE ANTERIOR TIBIAL ARTERY WITH CALCIFICATION. THE 2.5X200MM ARMADA 14 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER WAS BEING ADVANCED AND MET RESISTANCE DUE TO THE CALCIFIED ANATOMY. THE BALLOON WAS INFLATED ONCE; HOWEVER, DURING THE BEGINNING OF THE INFLATION THERE WAS NO PRESSURE AND CONTRAST LEAK WAS NOTED. ANOTHER UNSPECIFIED DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17663075 ↗
• MalfunctionJul 6, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE POSTERIOR TIBIAL ARTERY THAT WAS MODERATELY CALCIFIED. A 6FR SHEATH WAS USED UP AND OVER WITH FEMORAL ACCESS. THE ARMADA 14 PTA BALLOON CATHETER WAS PREPPED PRIOR TO USE WITHOUT ISSUE; HOWEVER, THE BALLOON RUPTURED IN THE PATIENT AFTER TWO INFLATIONS AT NOMINAL PRESSURE. A NEW SAME SIZE ARMADA BALLOON WAS USED TO CONTINUE THE PROCEDURE. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17271568 ↗
• MalfunctionMay 10, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED, MILDLY TORTUOUS, 75% STENOSED LESION IN THE POSTERIOR TIBIAL ARTERY. A COMMAND ES GUIDE WIRE (GW) CROSSED THE LESION AND THE 2.5X200MM ARMADA 14 BALLOON DILATATION CATHETER (BDC) WAS PREPARED PER THE INSTRUCTIONS FOR USE (IFU) AND ADVANCED TO THAT TARGET LESION. THE BALLOON WAS INFLATED ONCE TO NOMINAL PRESSURE WHEN A LEAK WAS NOTED IN HUB OF THE BDC. THE BDC WAS REMOVED AND A 3.0X200MM ARMADA 14 WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. 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 16906853 ↗
• MalfunctionApr 5, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE ANTERIOR TIBIAL ARTERY WITH 90% STENOSIS, HEAVY CALCIFICATION AND HEAVY TORTUOSITY. THE 2.5X200MM ARMADA 14 BALLOON DILATATION CATHETER (BDC) WAS ADVANCED WITHOUT RESISTANCE, HOWEVER, IT RUPTURED AT A PRESSURE OF 8 ATMOSPHERES (ATMS) DURING THE FIRST INFLATION. ANOTHER 2.5X120MM 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 16682321 ↗
• MalfunctionJan 16, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A FEMORAL ARTERY. THE 2.5X200MM ARMADA 14 BALLOON DILATATION CATHETER COULD NOT BE FULLY INFLATED AND BEGAN TO LEAK. IT WAS NOTED THREE ATTEMPTS WERE MADE AND RUPTURED OCCURRED AT 8 ATMOSPHERES. AFTER SEVERAL INFLATIONS WITH THE SAME BALLOON THE ARTERY WAS DILATATED. 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 16174069 ↗
• MalfunctionMay 17, 2022Leak/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 MODERATELY TORTUOUS, MODERATELY CALCIFIED DE NOVO ANTERIOR TIBIAL ARTERY. A COMMAND ES GUIDE WIRE WAS ADVANCED TO THE LESION. THEN A 2.5X200MM ARMADA 14 BALLOON WAS ADVANCED BUT WHEN INFLATED ONCE AT 8 ATMOSPHERES THERE WAS A CONTRAST LEAK COMING FROM THE GUIDE WIRE PORT OF THE DEVICE. THE ARMADA 14 BALLOON WAS REMOVED AND REPLACED WITH A 2.5X200MM NON-ABBOTT BALLOON TO SUCCESSFULLY COMPLETE THE PROCEDURE. IT WAS CONFIRMED THAT THE ARMADA BALLOON WAS NOT PREPPED (AIR ASPIRATION) OUTSIDE THE ANATOMY PRIOR TO USE. 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 14417407 ↗
• InjuryApr 7, 2022Difficult to Remove; Material Rupture; Material Separation; Difficult to Remove; Material Rupture; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE HEAVILY CALCIFIED POSTERIOR TIBIAL ARTERY. THE ARMADA 14 WAS ADVANCED TO THE LESION AND INFLATED BUT RUPTURED AT AN UNKNOWN PRESSURE. DIFFICULTY WAS NOTED DURING REMOVAL AND THE BALLOON PORTION OF THE DEVICE SEPARATED, WITH ABOUT 40 MM REMAINING IN THE ANATOMY. ATTEMPTS WERE MADE TO SNARE THE SEPARATED SEGMENT; HOWEVER, IT COULD NOT BE RETRIEVED. THE SEPARATED PORTION REMAINED IN THE DISTAL TIBIAL ARTERY. THE PATIENT RETURNED ON (B)(6) 2022 AND A BYPASS PROCEDURE WAS PERFORMED. POST PROCEDURE, THE PATIENT WAS DOING WELL. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 14047954 ↗
• MalfunctionMar 24, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING PREPARATION OF THE 2.5X200MM ARMADA 14 BALLOON DILATATION CATHETER WITH SALINE AND USE OF AN UNKNOWN INDEFLATOR AIR BUBBLES WERE NOTED. ANOTHER DEVICE WAS USED TO SUCCESSFULLY 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 13895724 ↗
• MalfunctionMar 8, 2022Material Rupture; Improper or Incorrect Procedure or Method; Material Rupture; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A POPLITEAL ARTERY. THE 2.5X200MM ARMADA 14 BALLOON RUPTURED AT 8 ATMOSPHERES DURING THE FIRST INFLATION. IT WAS NOTED THE DEVICE WAS NOT SOAKED PRIOR TO USE AND WAS NOT PREPPED (AIR ASPIRATION) OUTSIDE THE ANATOMY PRIOR TO USE. ANOTHER UNSPECIFIED SMALLER BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECTS REPORTED AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13694032 ↗
• MalfunctionFeb 23, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY CALCIFIED, 50% STENOSED LESION IN THE PERONEAL ARTERY. A 2.5X200MM ARMADA 14 BALLOON DILATATION CATHETER (BDC) WAS INFLATED ONE TIME TO 8 ATMOSPHERES (ATM) WHEN A RUPTURE OCCURRED. THE RUPTURE IS SUSPECTED TO BE CAUSED BY THE CALCIFIED ANATOMY. THE BDC WAS REMOVED WITHOUT ISSUE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. A 2X120MM ARMADA 14 BALLOON DILATATION CATHETER WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13588275 ↗
• MalfunctionNov 9, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THIS WAS A PROCEDURE TO TREAT A HEAVILY CALCIFIED RIGHT ANTERIOR TIBIAL ARTERY. AN ARMADA 14 2.5MM/200MM WAS INSERTED AND ADVANCED TO THE TARGET LESION. HOWEVER, DURING INFLATION, IT WAS OBSERVED THE BALLOON RUPTURED AT 8 ATMOSPHERES. THEREFORE, THE DEVICE WAS REMOVED AND REPLACED WITH A ARMADA 14 3MM/200MM. 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 12778508 ↗
• MalfunctionJul 9, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE HEAVILY CALCIFIED POPLITEAL ARTERY. THE 2.5X200 ARMADA 14 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER WAS INFLATED ONCE FOR DILATATION AT 8 ATMOSPHERES (ATM) FOR 180 SECONDS. THE BALLOON RUPTURED. A NEW, SAME SIZE ARMADA 14 PTA CATHETER 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 12144020 ↗
• MalfunctionApr 28, 2021Difficult to Insert; Leak/Splash; Difficult to Advance; Difficult to Insert; Leak/Splash; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A DE NOVO LESION IN THE HEAVILY CALCIFIED LEFT FIBULAR ARTERY. A 2.5X200MM ARMADA 14 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER HAD DIFFICULTY BEING INSERTED ONTO A COMMAND 14 GUIDE WIRE, AND THE DEVICES FACED RESISTANCE WITH EACH OTHER DURING POSITIONING. THE PTA BALLOON WOULD NOT MAINTAIN INFLATION. A 2.5X120MM ARMADA 14 PTA WAS USED WITH THE SAME COMMAND GUIDE WIRE 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 11738351 ↗
• MalfunctionNov 17, 2020Deflation Problem; Failure to Advance; Deflation Problem; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN ANTERIOR TIBIAL ARTERY. A 2.5X200MM ARMADA 14 WAS ADVANCED TO THE LESION AND INFLATED ONCE AT 12 ATMOSPHERES WITHOUT ISSUE. HOWEVER, WHEN ATTEMPTING TO DEFLATE, THE DEVICE WAS HELD NEGATIVE FOR OVER 5 SECONDS BUT THE BALLOON TOOK A PROLONGED TIME TO EVENTUALLY DEFLATE COMPLETELY SO THAT IT CAN BE USED FOR ANOTHER LESION. WHEN ATTEMPTED TO ADVANCE TO ANOTHER LESION, IT FAILED TO CROSS. IT WAS DECIDED THEN TO SIMPLY REMOVE THE DEVICE. A 2.5MM 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 10853028 ↗