Armada B1140-040Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 08717648155024), received between Jan 24, 2017 and Sep 18, 2023 — classified as 6 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (7 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjurySep 18, 2023Material Rupture; Material Separation; Component Missing; Difficult to Advance; Material Rupture; Material Separation; Component Missing; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE SUBCLAVIAN ARTERY. THE 14.0X40MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) WAS PREPARED OUTSIDE (AIR ASPIRATION) OUTSIDE THE ANATOMY PRIOR TO USE. THE BALLOON WAS USED FOR POST-DILATATION AND HAD RESISTANCE WITH THE ANATOMY DURING ADVANCEMENT. THE BALLOON WAS INFLATED ONCE AT NOMINAL PRESSURE BUT RUPTURED. THE BDC WAS REMOVED WITHOUT RESISTANCE, HOWEVER, THE BALLOON TORE IN HALF AND SEPARATED WHEN IT WAS TO THE LEVEL OF THE SHEATH. THERE WAS NO FORCE APPLIED. IT WAS BELIEVED THAT THERE WERE NO MARKERS SEEN ON THE BALLOON TO BEGIN WITH AND THERE WERE NO MARKERS ON FLUOROSCOPY FLOATING IN THE ANATOMY. THE TIP OF THE GUIDE WIRE WAS LOCATED INSTEAD AND GAINED ACCESS IN THE LEFT FEMORAL VEIN THROUGH THE ILIAC AND UP THE AORTA WITH A SNARED WIRE FROM BELOW AND THROUGH THE FEMORAL SHEATH, PUSHED THE NON-ABBOTT CATHETER THROUGH THE ARM OVER THE WIRE. THE PHYSICIAN WAS ABLE TO REMOVE ONE HALF OF THE BALLOON THROUGH THE ARM ACCESS SITE, AND REMOVED THE TIP OF THE BALLOON THAT WAS DETACHED FROM THE CATHETER THROUGH THE FEMORAL VEIN. NOTHING REMAINS IN THE ANATOMY. THE PATIENT RECEIVED MORE RADIATION, MORE CONTRAST, AND HAD TO H

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17765242 ↗
• InjuryOct 27, 2022Difficult to Remove; Material Rupture; Material Separation; Device Damaged by Another Device; Difficult to Remove; Material Rupture; Material Separation; Device Damaged by Another Device

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE LEFT COMMON ILIAC VEIN WITH 70% STENOSIS. THE 14.0X40MM ARMADA 35 BALLOON DILATATION CATHETER WAS ADVANCED WITHOUT RESISTANCE AND USED FOR POST-DILATATION, HOWEVER, IT RUPTURED DURING THE FIRST INFLATION AT 4 ATMOSPHERES (ATMS). THE DEVICE WAS PREPARED PER INSTRUCTIONS FOR USE (IFU). THE IMPLANTED STENT COMPRESSED WHEN THE BALLOON RUPTURED AND DURING WITHDRAWAL, THE BALLOON MATERIAL GOT CAUGHT ON THE STENT AND SHEARED THE STENT. THE PHYSICIAN PULLED IT BACK TO THE SHEATH, THEN PULLED SHEATH OUT WITH BALLOON AND THE WIRE WITHOUT FORCE. THE SHEATH WAS DISCARDED AND PART OF THE BALLOON MATERIAL MAY HAVE BEEN INSIDE THE SHEATH. IT ALSO NOTED THAT THE DISTAL MARKER WAS SHEARED OFF OF THE BALLOON AND WAS REMOVED AFTER PERFORMING EXPLORATORY CUT-DOWN SURGERY. THE PHYSICIAN WAS ABLE TO FIND AND REMOVE THE DISTAL MARKER OF THE BALLOON BUT DID NOT FIND ANY BALLOON MATERIAL IN THE ANATOMY. THE PATIENT UNDERWENT A COMPUTERIZED TOMOGRAPHY (CT) SCAN AND NO DISTAL BALLOON FRAGMENTS WERE FOUND IN THE ANATOMY BUT IT IS UNSURE IF FRAGMENTS REMAIN ON THE STENT IMPLANTED. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THE PAT

  Patient problems: Foreign Body In Patient

  MAUDE report 15680333 ↗
• MalfunctionJul 26, 2022Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE RIGHT COMMON FEMORAL VEIN. THE ARMADA 35 WAS INFLATED AND DEFLATED WITHOUT ISSUE; HOWEVER, DURING REMOVAL, THE DEVICE BECAME CAUGHT ON THE NON-ABBOTT GUIDE WIRE. THE DEVICES WERE REMOVED AS A SINGLE UNIT, WITHOUT DIFFICULTY. THERE WERE NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15108564 ↗
• InjuryNov 22, 2021Off-Label Use; Material Rupture; Material Separation; Off-Label Use; Material Rupture; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE LEFT ILIAC VEIN. A 14X40MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION WITHOUT ISSUE. UPON THE FIRST INFLATION TO NOMINAL PRESSURE, THE BALLOON RUPTURED. RESISTANCE WAS NOTED DURING REMOVAL OF THE BDC FROM THE ANATOMY. UPON REMOVAL, IT WAS NOTED THAT A PIECE OF BALLOON MATERIAL SEPARATED AND REMAINED IN THE VESSEL. A NON-ABBOTT STENT WAS ADVANCED WITHOUT ISSUE AND IMPLANTED TO COVER THE PIECE OF SEPARATED BALLOON. A NON-ABBOTT BDC WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 12857973 ↗
• MalfunctionOct 11, 2021Difficult to Remove; Material Rupture; Difficult to Remove; Material Rupture

  IT WAS REPORTED THIS PROCEDURE WAS PERFORMED TO TREAT A HEAVILY CALCIFIED AORTA. AN ARMADA 35 14MM/40MM WAS INSERTED AND ADVANCED TO THE TARGET LESION. IT WAS NOTED A STENT HAD BEEN PREVIOUSLY IMPLANTED IN THE SAME LOCATION. WHILE INFLATING THE BALLOON, IT WAS OBSERVED IT HAD RUPTURED AT 4 ATMOSPHERES. THE BALLOON WAS ATTEMPTED TO BE REMOVED, BUT IT BECAME CAUGHT ON THE GUIDE WIRE. THE RUPTURED BALLOON AND GUIDE WIRE REMAINED ATTACHED AND WERE ABLE TO BE REMOVED WITHOUT AS ONE WITHOUT CAUSING DAMAGE. NO PIECES OF THE BALLOON REMAINED IN THE ANATOMY. A SAME SIZE BALLOON WAS INSERTED, AND THE PATIENT WAS SUCCESSFULLY TREATED. 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 12606022 ↗
• MalfunctionJul 9, 2021Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT A 14X40MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) WAS RETURNED TO ABBOTT VASCULAR WITH THE PACKAGING TORN; THUS, STERILITY WAS BREACHED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12147162 ↗
• MalfunctionFeb 4, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE RIGHT COMMON ILIAC VEIN. A NON-ABBOTT STENT WAS IMPLANTED. THEN ONE 14 X 60 MM ARMADA 35 AND ONE 14 X 40 MM ARMADA 35 BALLOON DILATATION CATHETERS (BDC) WERE ADVANCED SIMULTANEOUSLY THROUGH TWO DIFFERENT ACCESS SITES FOR POST-DILATATION. HOWEVER, BOTH BALLOONS RUPTURED AT 6 ATMOSPHERES DURING THE FIRST INFLATION. BOTH ARMADA BDC DEVICES WERE SIMPLY REMOVED. THE PROCEDURE ENDED AT THIS POINT. THE PATIENT IS STABLE. 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 9664309 ↗
• MalfunctionJan 2, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION WITH HEAVY CALCIFICATION IN THE ILIAC ARTERY. THE 14 X 40 MM ARMADA 35 BALLOON CATHETER WAS ADVANCED TO THE TARGET LESION AND THE BALLOON WAS INFLATED BUT RUPTURED AT 4 ATMOSPHERES DURING THE FIRST INFLATION. THERE WAS NO RESISTANCE DURING ADVANCEMENT OR WITHDRAWAL OF THE DEVICE. A NEW ARMADA 35 BALLOON CATHETER WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. 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 9538248 ↗
• MalfunctionMar 30, 2018Difficult To Position; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS TO THE MODERATE TO HEAVILY TORTUOUS, 100% STENOSED, PROXIMAL TO DISTAL RIGHT SUPERFICIAL FEMORAL ARTERY (RSFA). AFTER PLACEMENT OF A HI-TORQUE (HT) VERSACORE GUIDE WIRE, A 4 X 150 MM ARMADA 35 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER WAS ADVANCED, BUT MET RESISTANCE WITH THE GUIDE WIRE AND WAS ONLY ABLE TO REACH THE PROXIMAL RSFA. THE BALLOON OF THE PTA CATHETER WAS INFLATED AND DEFLATED WITH NO ISSUES NOTED. DURING REMOVAL OF THE PTA CATHETER FROM THE ANATOMY, IT AGAIN MET RESISTANCE AND BECAME STUCK ON THE GUIDE WIRE. A NON-ABBOTT GUIDE WIRE WAS PLACED TO SERVE AS A BUDDY WIRE SO ACCESS WAS NOT LOST AND THE HT VERSACORE GUIDE WIRE & ARMADA PTA CATHETER WERE REMOVED FROM THE ANATOMY AS A UNIT. THE PROCEDURE WAS COMPLETED WITH THE SUCCESSFUL STENTING OF THE COMPLETE RSFA. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7386929 ↗
• InjuryMay 11, 2017Detachment Of Device Component; Difficult To Position; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HIGHLY STENOSED LESION IN THE VENA CAVA ARTERY. A 14 X 40 MM ARMADA 35 BALLOON SEPARATED WHILE INSIDE THE PATIENT. THE SEPARATED PORTION WAS NOT RECOVERED. ADDITIONALLY, RESISTANCE WITH AN UNKNOWN GUIDE WIRE WAS FELT WHEN ADVANCING AND WITHDRAWING THE DEVICE. IT IS UNKNOWN AS TO HOW MANY ATMOSPHERES THE BALLOON WAS INFLATED BECAUSE IT WAS INFLATED WITH HAND INJECTIONS. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 6560307 ↗
• InjuryMay 8, 2017Detachment Of Device Component; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE SUBCLAVIAN VEIN. AFTER SUCCESSFUL PRE-DILATATION, AND DURING REMOVAL, THE ARMADA 35 14 MM / 40 MM ON 80 CM BALLOON DILATATION CATHETER BALLOON GOT STUCK INSIDE A STENT IN THE BASILICA VEIN AND A PIECE OF THE BALLOON CAME OFF. THERE WAS A REPORTED DELAY AS A CUT DOWN PROCEDURE WAS NEEDED TO REMOVE THE SEPARATED PIECE OF THE BALLOON, HOWEVER IT WAS NOT CLINICALLY SIGNIFICANT AS THERE WERE NO ADVERSE PATIENT EFFECTS. THE DEVICE WAS PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6552951 ↗
• InjuryJan 24, 2017Detachment Of Device Component; Material Rupture; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A RESTENOSED LESION LOCATED IN THE INFERIOR VENA CAVA (IVC) WITH CHRONIC TOTAL OCCLUSION. RESISTANCE WAS NOT FELT AS A 14 X 40 MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE LESION AND IT CROSSED SUCCESSFULLY. THE BALLOON WAS INFLATED PAST THE RATED BURST PRESSURE (RBP) TO 12 ATMOSPHERES IN ORDER TO OPEN THE VESSEL; HOWEVER, THE BALLOON RUPTURED WITHOUT OPENING THE VESSEL. A PIECE OF THE BALLOON DETACHED FROM THE BDC WHEN IT RUPTURED. A SNARE DEVICE WAS USED TO RETRIEVE THE PIECE OF BALLOON AND IT WAS CONFIRMED THAT NO BALLOON FRAGMENTS REMAINED IN THE ANATOMY. A NON-ABBOTT BALLOON WAS USED TO SUCCESSFULLY TREAT THE LESION. THE PATIENT OUTCOME WAS GOOD. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6274886 ↗