Armada B1100-020Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 08717648154935), received between Sep 6, 2017 and Jul 13, 2023 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (4 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 13, 2023Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT THE SHIPPING BOX WAS CUT OPEN AND THE PRODUCT WAS TAKEN OUT OF THE SHIPPING BOX, WHEN IT WAS NOTICED THAT THE CHIPBOARD BOX WAS CUT OPEN AS WELL. THE STERILE PACKAGING WAS POSSIBLY DAMAGED; THEREFORE, STERILITY IS UNKNOWN. THE DEVICE WAS NOT USED IN A PATIENT. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAYS IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17321422 ↗
• MalfunctionJun 8, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED, MILDLY TORTUOUS LESION IN THE COMMON FEMORAL ARTERY (CFA). A 10MMX20MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) WAS ADVANCED FOR POST-DILATATION OF AN IMPLANTED STENT. THE BALLOON WAS INFLATED ONCE TO 6 ATMOSPHERES (ATM) AND A SECOND TIME TO 12ATM WHEN A BALLOON RUPTURE OCCURRED. A 10MMX40MM ARMADA 35 BDC 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 17090372 ↗
• MalfunctionNov 14, 2022Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT DURING DEVICE PREPARATION OF THE 10 X 20 MM ARMADA 35 DILATATION CATHETER, IT WAS NOTED THAT THE PLASTIC ON THE BALLOON WAS PEELING . THE DEVICE WAS NOT USED AND THERE WAS NO PATIENT INVOLVEMENT. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. A SECOND SAME DEVICE WAS USED WITHOUT ISSUE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15789420 ↗
• MalfunctionJun 15, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO, 99% STENOSED, MILDLY CALCIFIED LESION IN THE MODERATELY TORTUOUS FEMORAL ARTERY. THE ARMADA 35 BALLOON CATHETER WAS ADVANCED TO THE LESION, WITHOUT ISSUE; HOWEVER, DURING THE FIRST INFLATION AT 4 ATMOSPHERES, THE BALLOON LEAKED CONTRAST. THE DEVICE WAS REMOVED. THERE WAS NO ADVERSE PATIENT EFFECT OR A CLINICALLY SIGNIFICANT DELAY IN PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12005270 ↗
• InjuryFeb 13, 2020Difficult to Remove; Material Rupture; Material Separation; Difficult to Remove; Material Rupture; Material Separation

  USER FACILITY MEDWATCH REPORT RECEIVED THAT STATES: [A (B)(6) Y/0 WITH HISTORY OF PREMATURELY (BORN (B)(6) WKS), PRIOR BOWEL RESECTION. HE WAS DIAGNOSED WITH PORTAL VEIN THROMBOSIS AT YOUNG AGE, WITH RESULTANT PORTAL HYPERTENSION AND CIRRHOSIS. HE HAD A MESOCAVAL SHUNT PLACED AT AGE (B)(6) AND PRIOR ANGIOPLASTY FOR SHUNT STENOSIS. HE RECENTLY UNDERWENT BANDING FOR ESOPHAGEAL VARICES IN (B)(6) 2019. HE WAS ADMITTED FOR ANGIOGRAM AND POSSIBLE ANGIOPLASTY OF HIS MESOCAVAL SHUNT ON (6)(6) 2019 BY INTERVENTIONAL RADIOLOGY. ACCESS WAS OBTAINED THROUGH THE RIGHT COMMON FEMORAL SITE USING A 7 FR SHEATH UNDER ULTRASOUND GUIDANCE. A ROSEN WIRE WAS ADVANCED BEYOND THE MESOCAVAL SHUNT. AT 10 MM X2 CM ANGIOPLASTY BALLOON WAS ADVANCED TO THE SITE OF THE STENOSIS AT THE IVC ANASTOMOSIS AND INFLATED. THE BALLOON WAS THEN DEFLATED AND THEN SLIGHTLY REPOSITIONED. DURING RE-INFLATION OF THE BALLOON, IT RUPTURED IN A CIRCUMFERENTIAL FASHION WITH THE DISTAL PORTION OF THE BALLOON CREATING A FREE-FLOATING FRAGMENT. THE BALLOON INFLATION PRESSURES WERE MONITORED THROUGHOUT THE PROCEDURE AS IS TYPICAL. THE PRESSURE WAS REPORTED AS BEING 8 ATMS AT THE TIME OF RUPTURE. THE BALLOON FRAGMENT CAUGHT ON THE DIS

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9707104 ↗
• MalfunctionSep 6, 2017Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN 80% STENOSIS IN A HEAVILY CALCIFIED SUPERFICIAL FEMORAL ARTERY (SFA) AND A 90% STENOSIS IN A HEAVILY CALCIFIED COMMON ILIAC ARTERY. A 6 X 80 MM ARMADA 35 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER WAS SELECTED FOR PRE-DILATATION OF THE LESION IN THE SFA. THE PTA CATHETER WAS ADVANCED TO THE LESION AND WHEN INFLATED TO 10 ATMOSPHERES (ATM) THE BALLOON RUPTURED. A NEW 7 X 80 MM ARMADA 35 PTA CATHETER WAS USED TO COMPLETE THE PRE-DILATATION AND AN UNSPECIFIED STENT IMPLANT WAS SUCCESSFULLY DEPLOYED. FOLLOWING DEPLOYMENT OF AN UNSPECIFIED STENT IMPLANT IN THE COMMON ILIAC ARTERY, A 10 X 20 MM ARMADA 35 PTA CATHETER WAS SELECTED FOR POST- DILATATION. WHEN INFLATED TO 13 ATM THE BALLOON RUPTURED AND WAS REPLACED WITH A 12 X 20 MM ARMADA 35 PTA CATHETER. WHEN INFLATED TO 10 ATM THE BALLOON RUPTURED. AS THERE WAS SUFFICIENT WALL APPOSITION ADDITIONAL POST-DILATATION WAS NOT NECESSARY. 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 6846279 ↗