Armada B2070-040Recalls & reported problems

Summary

The FDA's MAUDE database contains 38 adverse event reports that list this exact device (DI 08717648155352), received between Nov 2, 2016 and Sep 30, 2026 — classified as 13 injuries, 25 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (31 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 38 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Material Rupture; Difficult to Advance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50949204 ↗
• MalfunctionSep 29, 2026Leak/Splash; Improper or Incorrect Procedure or Method

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50936001 ↗
• MalfunctionFeb 12, 2026Leak/Splash; Deformation Due to Compressive Stress

  DURING RETURNED DEVICE ANALYSIS, NO LEAK WAS IDENTIFIED. THE ACCOUNT CONFIRMED THAT THE CORRECT DEVICE WAS RECEIVED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24322477 ↗
• MalfunctionNov 20, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A SEVERELY CALCIFIED LESION IN THE RIGHT SUPERFICIAL FEMORAL ARTERY. THE 7.0X40MM ARMADA 35 BALLOON DILATATION CATHETER WAS ADVANCED TO THE TARGET LESION HOWEVER THE BALLOON RUPTURED DURING THE FIRST INFLATION AT 16 ATMOSPHERES. THE DEVICE WAS REMOVED WITHOUT ISSUE. THE PROCEDURE WAS COMPLETED USING NON-ABBOTT DEVICES. 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 23605733 ↗
• MalfunctionOct 15, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A MILDLY CALCIFIED LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA). A 7X40MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) WAS PREPARED AND ADVANCED TO THE LESION WITH NO NOTED ISSUES; HOWEVER, DURING THE FIRST INFLATION THE BALLOON WAS NOTED TO RUPTURE AT 4ATMS. THEREFORE, THE BDC WAS REPLACED WITH A 8X40MM ARMADA 35 BDC, BUT AFTER BEING PREPARED AND ADVANCED TO THE LESION WITH NO NOTED ISSUES, THE BALLOON WAS NOTED TO RUPTURE AT 2ATMS DURING THE FIRST INFLATION. AT THIS POINT, THE RUPTURED BDC WAS REMOVED AND A 7X40MM JADE BDC WAS USED AND THE PROCEDURE WAS CONTINUED. THERE WERE NO ADVERSE PATIENT EFFECTS NOR CLINICAL DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23297385 ↗
• InjuryJun 2, 2025Difficult to Remove; Material Rupture; Material Separation; Difficult to Advance; Difficult to Remove; Material Rupture; Material Separation; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS AN ENDOVASCULAR ABDOMINAL AORTIC ANEURYSM REPAIR (EVAR) AND RENAL STENTING. THE 7X40 MM ARMADA 35 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER WAS ADVANCED TO THE LESION WITH RESISTANCE NOTED WITH THE ANATOMY. THE BALLOON RUPTURED AFTER 4-5 INFLATIONS AND DEFLATIONS TO NOMINAL PRESSURE AND RUPTURED AT 6 ATMOSPHERES. THERE WAS RESISTANCE WITH THE ANATOMY DURING REMOVAL. THE BALLOON CATHETER SNAPPED INTO TWO PIECES AND A PORTION REMAINED IN THE PATIENT ANATOMY. THIRTY MINUTES WAS SPENT TO RETRIEVE THE SEPARATED PIECE WITH A SNARE. THERE WERE NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22122586 ↗
• MalfunctionMay 26, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A SEVERELY TORTUOUS AND HEAVILY CALCIFIED LESION IN THE RIGHT COMMON FEMORAL ARTERY. A 7X40MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) WAS PREPARED WITH NO NOTED ISSUES, AND ADVANCED TO THE LESION WITHOUT RESISTANCE TO BE USED FOR VESSEL DILATATION; HOWEVER, DURING THE FIRST INFLATION AT 8 ATMOSPHERES THE BALLOON WAS NOTED TO RUPTURE. AT THIS POINT THE BDC WAS REMOVED AND A NEW 8X40MM ARMADA BDC WAS PREPARED AND ADVANCED TO THE LESION WITH NO NOTED ISSUES; BUT THE BALLOON RUPTURED DURING THE FIRST INFLATION AT 10 ATMOSPHERES. THEREFORE, THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH TWO NON-ABBOTT BALLOON CATHETERS. 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 22084464 ↗
• InjuryMay 19, 2025Difficult to Remove; Material Rupture; Material Separation; Improper or Incorrect Procedure or Method; Difficult to Remove; Material Rupture; Material Separation; Improper or Incorrect Procedure or Method

  SUBSEQUENT TO THE INITIAL REPORT BEING FILED, THE IT WAS REPORTED RESISTANCE WAS NOTED DURING REMOVAL OF THE BDC WITH THE SHEATH AND THE DISTAL PORTION OF THE BALLOON SEPARATE INSIDE THE PATIENT. THEREFORE, AN ADDITIONAL BALLOON WAS USED TO TRAP THE SEPARATED SEGMENT AGAINST THE SHEATH TO REMOVE THE SEPARATED SEGMENT. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22045062 ↗
• MalfunctionMay 5, 2025Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE EXTERNAL ILIAC ARTERY WITH HEAVY CALCIFICATION AND STENOSIS. THE 7X40 MM ARMADA 35 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER WAS ADVANCED FOR POST-DILATATION WITH RESISTANCE NOTED WITH THE ANATOMY; HOWEVER, THE BALLOON RUPTURED DURING THE FIRST INFLATION TO 6 ATMOSPHERES. THE BALLOON SPLIT VERTICALLY AND WAS SUCCESSFULLY REMOVED INTO THE SHEATH AND REMOVED INDEPENDENTLY. 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 21962487 ↗
• MalfunctionMar 12, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN AN UNKNOWN VESSEL. A 7X40MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) WAS ATTEMPTED TO BE USED DURING A TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR); HOWEVER A HOLE IN THE BALLOON WAS NOTED. THEREFORE THE BDC WAS REPLACED WITH ANOTHER ABBOTT BALLOON. THERE WERE NO ADVERSE PATIENT EFFECTS NOR CLINICAL DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED. SUBSEQUENT TO THE INITIALLY REPORTED INFORMATION, A DEVICE WAS RECEIVED; HOWEVER, IT CAN BE ASSUMED THAT THE DEVICE RECEIVED WAS THE REPLACEMENT DEVICE USED AS THERE WERE NO NOTED ISSUES FOUND DURING THE PRODUCT RETURNED ANALYSIS. THEREFORE, THE DEVICE RETURN STATUS WILL BE UPDATED TO NOT RETURNING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21586026 ↗
• MalfunctionFeb 19, 2025Inflation Problem; Material Rupture; Inflation Problem; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A CONCENTRIC CALCIFIED, ILIAC VESSEL THAT IS 50% STENOSED. THE BALLOON OF A 7.0X40MM ARMADA 35 BALLOON DILATATION CATHETER WAS OBSERVED TO BE LOSING PRESSURE AT NOMINAL PRESSURE WHEN ATTEMPTING TO INFLATE. THE BALLOON ONLY PARTIALLY INFLATED. AN UNSPECIFIED DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21417078 ↗
• InjuryFeb 2, 2024Material Rupture; Material Separation; Material Rupture; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE RIGHT ILIAC ARTERY. THE 7.0X40MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) WAS INFLATED, HOWEVER, CONTRAST EXTRAVASATION WAS NOTED AND TRIED TO INFLATE AGAIN BUT CONFIRMED TO HAVE RUPTURED. THE BALLOON WAS TAKEN OFF OF THE WIRE, HOWEVER, ONLY HALF OF THE BALLOON WAS REMOVED. ATTEMPTED TO RETRIEVE THE SEPARATED PORTION USING A SNARE DEVICE AND OTHER TECHNIQUES (MULTIPLE ACCESS POINTS) BUT UNSUCCESSFUL. THE PHYSICIAN FIGURED OUT THE SEPARATED PORTION WAS STILL ON THE WIRE AND MANAGED TO REMOVE IT WITH A DIAGNOSTIC CATHETER. THERE WAS NO ADVERSE PATIENT EFFECT. ALTHOUGH THERE WAS A DELAY, IT WAS CONFIRMED THERE WAS NO ADVERSE PATIENT EFFECT, THEREFORE, THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18634809 ↗
• InjurySep 18, 2023Entrapment of Device; Material Rupture; Entrapment of Device; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED LILAC ARTERY. THE 7X40MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) WAS ADVANCED WITH A 7F CATHETER ONCE AT THE LESION THE BALLOON WAS INFLATED AT 6 ATMOSPHERE AND RUPTURED. IT WAS NOT POSSIBLE TO RETRIEVE THE BALLOON THREW THE CATHETER AS SEVERAL ATTEMPTS WERE MADE. THE BALLOON WITH THE GUIDING CATHETER WAS REMOVED VIA CUT DOWN. IT WAS NOTED DURING THE CUT DOWN THE BALLOON HAD TO BE CUT INTO SEPARATE PIECES IN ORDER TO REMOVE THE DEVICE. THERE WAS NO ADVERSE PATIENT SEQUELA; HOWEVER, CLINICALLY SIGNIFICANT DELAY WAS NOTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17765531 ↗
• MalfunctionAug 11, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN AN UNSPECIFIED VESSEL. REPORTEDLY, AT THE TIME OF INFLATING THE BALLOON OF A 7.0 X 40MM ARMADA 35 BALLOON CATHETER, IT LEAKED AND DID NOT INFLATE COMPLETELY. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17510909 ↗
• InjuryFeb 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(4). IT WAS REPORTED THAT THE PATIENT UNDERWENT A PROCEDURE TREATING A TARGET LESION IN THE MID RIGHT SUPERFICIAL FEMORAL ARTERY (SFA). BALLOON ANGIOPLASTY WAS PERFORMED USING THE 7.0 X 40 MM ARMADA 35 DILATATION CATHETER. A DISSECTION OCCURRED AFTER ANGIOPLASTY. AN 8.0 X 120 MM ABSOLUTE PRO LL STENT, WAS IMPLANTED, TREATING BOTH THE TARGET LESION AND THE DISSECTION. THE EVENT RESOLVED THE DAY OF PROCEDURE, (B)(6) 2023. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Vascular Dissection

  MAUDE report 16410811 ↗
• MalfunctionNov 28, 2022Material Rupture; Material Rupture

  ADDITIONAL INFORMATION WAS PROVIDED WHICH REPORTED THAT THE BALLOON RUPTURED AT 8 ATMOSPHERES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15874786 ↗
• InjuryNov 7, 2022Difficult to Remove; Material Rupture; Material Separation; Difficult to Remove; Material Rupture; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED SUPERFICIAL FEMORAL ARTERY (SFA). THE 3.0X40MM ARMADA 18 BALLOON DILATATION CATHETER (BDC) RUPTURED DURING THE FIRST INFLATION AT 4 ATMOSPHERES (ATM). THE BDC WAS REMOVED WITHOUT ISSUE AND A 7.0X40MM ARMADA 35 BDC WAS INFLATED TO 4 ATMS; HOWEVER, RUPTURED DURING THE FIRST INFLATION. THE ARMADA 35 BDC WAS REMOVED; HOWEVER, RESISTANCE WAS FELT WITH THE 6FR SHEATH. THE BALLOON WAS NOTED TO STILL REMAIN IN THE PATIENT. SNARING OF THE SEPARATED PORTION WAS ATTEMPTED; HOWEVER, NOT SUCCESSFUL. THE PATIENT WAS TAKEN INTO SURGERY TO REMOVE THE BALLOON; HOWEVER, IT IS UNKNOWN IF THE SEPARATED PORTION WAS SUCCESSFULLY REMOVED. THERE IS NO CLINICALLY SIGNIFICANT DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 15749599 ↗
• InjuryAug 3, 2022Difficult to Remove; Material Rupture; Material Separation; Difficult to Remove; Material Rupture; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE ATRIOVENTRICULAR (AV) FISTULA IN THE RIGHT ARM, HEAVILY CALCIFIED AND HEAVILY TORTUOUS. THE 7X40 MM ARMADA 35 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER WAS ADVANCED TO THE TARGET LESION AND WHEN INFLATED TO 6 ATMOSPHERES (ATM), THE BALLOON RUPTURED. DURING REMOVAL OF THE CATHETER THERE WAS SLIGHT RESISTANCE WITH THE SHEATH DUE TO THE RUPTURE AND THE BALLOON SEPARATED IN PIECES. THE PHYSICIAN HAD TO WIDEN THE ACCESS SITE AND WITH HEMOSTATS REMOVED THE BALLOON PIECES SUCCESSFULLY. THE PHYSICIAN CONFIRMED THERE WERE NO PIECES LEFT IN THE PATIENT'S ANATOMY. A DIFFERENT ACCESS SITE WAS USED AND A NEW BALLOON CATHETER WAS USED TO COMPLETE THE PROCEDURE. THE VESSEL WAS PATENT WITH NO EMBOLISM NOTED. THE PATIENT IS DOING WELL. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15158088 ↗
• 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 LEFT ILIAC ARTERY. THE ARMADA 35 WAS ADVANCED TO THE LESION AND INFLATED BUT RUPTURED AT AN UNKNOWN PRESSURE. DIFFICULTY WAS NOTED DURING REMOVAL, AS THE BALLOON ACCORDIONED ON THE SHAFT. THE BALLOON PORTION SEPARATED AND WAS ABLE TO BE SNARED. ALL PORTIONS OF THE DEVICE WERE REMOVED FROM THE PATIENT ANATOMY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions

  MAUDE report 14047158 ↗
• MalfunctionJan 26, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE LEFT POPLITEAL ARTERY. AFTER ATHERECTOMY, A STENT WAS IMPLANTED AND THE 7.0X40MM ARMADA 35 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER WAS USED FOR POST DILATATION. THE DEVICE WAS PREPARED (AIR ASPIRATION) OUTSIDE THE ANATOMY PRIOR TO USE, WITHOUT ANY ISSUES AND THERE WAS NO RESISTANCE DURING ADVANCEMENT. HOWEVER, THE BALLOON RUPTURED AT 12 ATMOSPHERES (ATMS) DURING THE FIRST INFLATION. ANOTHER SAME SIZE BALLOON COMPLETED 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 13358588 ↗
• MalfunctionOct 12, 2021Break; Leak/Splash; Break; Leak/Splash

  IT WAS REPORTED THAT DURING PREPARATION OF THE 7X40MM ARMADA 35 BALLOON DILATATION CATHETER (BDC), WHEN PULLING NEGATIVE ON THE INDEFLATOR, AIR BUBBLES WERE SEEN ON THE SHAFT. A CRACK IS SUSPECTED SOMEWHERE ON THE DEVICE. THE DEVICE WAS NOT USED AND WAS REPLACED WITH A NEW ARMADA 35 BDC. THERE WAS NO CLINICALLY SIGNIFICANT DELAY DURING THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12616241 ↗
• InjuryJul 13, 2021Off-Label Use; Material Rupture; Material Separation; Off-Label Use; Material Rupture; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY TORTUOUS, MILDLY CALCIFIED DE NOVO SUBCLAVIAN VEIN THAT WAS 80% STENOSED. A 7X40MM ARMADA 35 BALLOON WAS INFLATED ONCE AND RUPTURED TRANSVERSELY AT 15 ATMOSPHERES. ANOTHER SAME SIZE ARMADA 35 WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. DEVICE ANALYSIS NOTED THE BALLOON AND INNER MEMBER WERE SEPARATED DISTAL TO THE BALLOON PROXIMAL SEAL AND THE SEPARATED PORTIONS WERE NOT RETURNED. THE ACCOUNT CONFIRMED THAT THE SEPARATION OCCURRED DURING THE PROCEDURE AND THAT THE SEPARATED DEVICE PORTIONS WERE REMOVED VIA SNARE. ANGIOGRAPHY CONFIRMED THAT NOTHING REMAINED IN THE PATIENT¿S ANATOMY. ADDITIONAL INFORMATION WAS RECEIVED BY THE ACCOUNT STATING: THE ARMADA BALLOON WAS USED TO DILATE THE STENOSED SYNTHETIC ARTERIOVENOUS FISTULA GRAFT INSTEAD OF THE CENTRAL SUBCLAVIAN VEIN AS INITIALLY REPORTED. AFTER THE BALLOON RUPTURED AT 15 ATMOSPHERES, THE PHYSICIAN FOUND NO RESIDUAL DEVICE IN THE PATIENT'S BODY VIA ANGIOGRAPHY. HOWEVER, IT WAS LATER CONFIRMED THAT THE ARMADA 35 BALLOON HAD SEPARATED AND THE SEPARATED PORTIONS WERE NEVER SNARED AS P

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12160452 ↗
• MalfunctionJun 10, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A RESTENOSED AND HEAVILY CALCIFIED LESION IN THE COMMON ILIAC ARTERY. A 7X40MM ARMADA 35 BALLOON CATHETER WAS PREPARED PER THE INSTRUCTIONS FOR USE. THE BALLOON WAS INFLATED ONCE TO 6 ATMOSPHERES FOR 180 SECONDS; HOWEVER, THE BALLOON RUPTURED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A NEW 7X40MM 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 11975399 ↗
• MalfunctionMar 26, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE ILIAC ARTERY. A 7.0X40MM ARMADA 35 WAS INFLATED MULTIPLE TIMES AND ON THE 5TH TIME THE BALLOON RUPTURED AT AN UNKNOWN PRESSURE. THE DEVICE WAS REMOVED AND ANOTHER NON-ABBOTT DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11576427 ↗
• MalfunctionDec 10, 2020Material Rupture; Material Separation; Material Rupture; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION WITH MILD CALCIFICATION, MILD TORTUOSITY, AND 80% STENOSIS IN THE ARTERIOVENOUS FISTULA. ALTHOUGH NO RESISTANCE NOTED DURING ADVANCEMENT, A 7.0 X 40MM ARMADA 35 BALLOON RUPTURED DURING FIRST INFLATION AT RATED BURST PRESSURE. THE BALLOON DILATATION CATHETER WAS WITHDRAWN WITHOUT RESISTANCE; HOWEVER, THE PROXIMAL SHAFT SEPARATED INTO TWO PIECES AFTER BEING REMOVED FROM THE ANATOMY. ANOTHER SAME SIZE ARMADA 35 BALLOON WAS USED TO COMPLETE 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 Consequences Or Impact To Patient

  MAUDE report 10987990 ↗