Armada A2030-080Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 08717648156090), received between Jan 19, 2018 and Jan 30, 2024 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (5 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 30, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN AN UNSPECIFIED VESSEL. THE 3.0X80 MM ARMADA 14 AND 2.0X120 MM ARMADA 14 BALLOON DILATATION CATHETERS (BDC) WERE PREPARED WITHOUT ISSUE. THE 3X80 MM ARMADA BDC WAS ADVANCED TO THE LESION AND INFLATED, HOWEVER IT RUPTURED AT 6 ATMOSPHERES DURING THE THIRD INFLATION. THE BALLOON WAS REMOVED WITHOUT ISSUE. THE 2X120 MM ARMADA BDC WAS THEN ADVANCED TO THE LESION AND INFLATED; HOWEVER, IT ALSO RUPTURED AT 6 ATMOSPHERES DURING THE SECOND INFLATION. THE BALLOON WAS REMOVED WITHOUT ISSUE. A 0.9 LASER AND MINI TREK BALLOON WERE USED TO 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 18610321 ↗
• MalfunctionJul 20, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE 3.0X80 MM ARMADA PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER RUPTURED. ANOTHER ABBOTT BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED 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 17367133 ↗
• MalfunctionJul 11, 2023Inflation Problem; Leak/Splash; Inflation Problem; Leak/Splash

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE ANTERIOR TIBIAL ARTERY WITH 75% STENOSIS, MODERATE CALCIFICATION AND MILD TORTUOSITY. A COMMAND ES GUIDE WIRE WAS INSERTED. THERE WAS NO DIFFICULTY REMOVING THE PROTECTIVE SHEATH AND THE 3.0X80MM ARMADA 14 BALLOON DILATATION CATHETER (BDC) WAS ADVANCED BUT WHEN ATTEMPTING TO INFLATE THE BALLOON AT NOMINAL PRESSURE, THE BALLOON DID NOT OPEN TO ITS FULL PROFILE AS THERE WAS LEAKAGE IN THE HUB. THE BDC WAS REMOVED. ANOTHER 3.0X120MM ARMADA 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 17302137 ↗
• MalfunctionMar 27, 2023Inflation Problem; Leak/Splash; Inflation Problem; Leak/Splash

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE RIGHT POSTERIOR TIBIAL ARTERY WITH MODERATE CALCIFICATION. THE 3.0X80MM ARMADA 14 BALLOON DILATATION CATHETER (BDC) WAS PREPARED PER THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DIFFICULTY REMOVING THE STYLET OR PROTECTIVE SHEATH. THE BALLOON CATHETER WAS ADVANCED WITHOUT ISSUES; HOWEVER, DURING THE FIRST INFLATION, IT WAS NOTED THAT THE PRESSURE WAS NOT HOLDING WELL. ON THE SECOND INFLATION AT 8 ATMOSPHERES A LEAK AT THE HUB WAS NOTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE REPORTED DEVICE. 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 16620065 ↗
• MalfunctionSep 8, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE POSTERIOR TIBIAL ARTERY WITH 90% STENOSIS AND MILD CALCIFICATION. THE 3.0X80MM ARMADA 14 BALLOON DILATATION CATHETER (BDC) HAD NO RESISTANCE DURING ADVANCEMENT BUT RUPTURED BELOW THE RATED BURST PRESSURE (RBP) AT 6 ATMOSPHERES (ATMS) DURING THE FIRST INFLATION. THERE WAS NO ADVERSE PATIENT EFFECT. ALTHOUGH THERE WAS SOME DELAY IN SURGERY TIME, THERE WAS NO HARM TO THE PATIENT; THEREFORE THE DELAY IS NOT CONSIDERED CLINICALLY SIGNIFICANT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15384437 ↗
• MalfunctionJan 6, 2022Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT ON (B)(6) 2021, A 3X80MM ARMADA 14 BALLOON DILATATION CATHETER (BDC), WAS ON A WIRE CART IN THE CATH LAB, READY TO BE PUT AWAY FOR FUTURE USE, WHEN IT WAS NOTICED THAT THE BLUE CHIPBOARD BOX WAS BENT AND TORN. IT IS SUSPECTED, THERE WAS DAMAGE TO THE INNER POUCH AND STERILITY WAS BREACHED. THE DEVICE WAS NOT BEING PREPARED FOR A PROCEDURE. THERE WAS NO 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 13177241 ↗
• MalfunctionJul 10, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE 3.0 X 80 MM ARMADA 14 BALLOON RUPTURED DURING INFLATION. NO ADVERSE PATIENT EFFECT OR CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7675650 ↗
• MalfunctionMar 9, 2018Kinked; Difficult To Position; Difficult to Remove

  IT WAS REPORTED THE PROCEDURE WAS PERFORMED TO TREAT AN UN-SPECIFIED LESION. THE 3.0 X 80 MM ARMADA 14 BALLOON DILATATION CATHETER (BDC) WAS USED.; HOWEVER, BECAME STUCK AND KINKED DURING USE. ANOTHER ARMADA BDC 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 Consequences Or Impact To Patient

  MAUDE report 7329270 ↗
• MalfunctionJan 19, 2018Material Rupture

  IT WAS REPORTED THAT DURING A PROCEDURE TO TREAT A LESION IN A MODERATELY CALCIFIED ARTERY, THE 3.0 MM X 80 MM X 150 CM ARMADA 14 BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION WITHOUT ISSUE. DURING THE FIRST INFLATION, THE BALLOON RUPTURED AT 10 ATMOSPHERES DUE TO THE CALCIFICATION. THE BDC WAS REPLACED WITH ANOTHER ARMADA 14 BDC 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 Consequences Or Impact To Patient

  MAUDE report 7206373 ↗