ArmadaRecalls & reported problems across all models
Abbott Vascular Inc. · 213 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1,904
- Deaths reported
- 2
- Injuries reported
- 255
- Recalls
- 0
We found 213 models of Armada by Abbott Vascular Inc. in the FDA's device registry (GUDID). Together they are named in 1,904 adverse event reports in the FDA's MAUDE database, received between Aug 2, 2016 and Sep 30, 2026 — classified as 2 deaths, 255 injuries, 1,647 malfunctions.
The most frequently reported specific device problem is “Material Rupture” (1,296 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Armada problems
Device problems
- Material Rupture1,296
- Difficult to Remove300
- Leak/Splash288
- Material Separation231
- Improper or Incorrect Procedure or Method181
- Difficult to Advance170
- Inflation Problem146
- Deflation Problem82
Patient problems
- No Clinical Signs, Symptoms or Conditions1,038
- No Consequences Or Impact To Patient694
- No Patient Involvement51
- Foreign Body In Patient38
- Insufficient Information23
- Device Embedded In Tissue or Plaque18
- Hemorrhage/Blood Loss/Bleeding11
- Vascular Dissection9
Armada models
213 models, 100 per page, most reported first. Each model has its own page with its reports, recalls and device details.
- Armada B1070-040Catheter, angioplasty, peripheral, transluminal82 reports
- Armada B1060-040Catheter, angioplasty, peripheral, transluminal65 reports
- Armada B1050-040CATHETER, PERCUTANEOUS64 reports
- Armada B1080-040Catheter, angioplasty, peripheral, transluminal63 reports
- Armada A2020-200CATHETER, PERCUTANEOUS49 reports
- Armada B2070-040Catheter, angioplasty, peripheral, transluminal38 reports
- Armada B1120-040Catheter, angioplasty, peripheral, transluminal35 reports
- Armada A2025-200Catheter, angioplasty, peripheral, transluminal35 reports
- Armada A2030-120CATHETER, PERCUTANEOUS35 reports
- Armada 1013470-200Catheter, angioplasty, peripheral, transluminal35 reports
- Armada 1013470-150Catheter, angioplasty, peripheral, transluminal31 reports
- Armada B1070-060CATHETER, PERCUTANEOUS30 reports
- Armada B1070-080CATHETER, PERCUTANEOUS30 reports
- Armada A2030-200CATHETER, PERCUTANEOUS30 reports
- Armada B1100-040Catheter, angioplasty, peripheral, transluminal29 reports
- Armada A2025-120CATHETER, PERCUTANEOUS28 reports
- Armada B2060-200Catheter, angioplasty, peripheral, transluminal26 reports
- Armada A2020-120CATHETER, PERCUTANEOUS24 reports
- Armada B2060-040CATHETER, PERCUTANEOUS23 reports
- Armada B1080-060Catheter, angioplasty, peripheral, transluminal1 death21 reports
- Armada B2060-060CATHETER, PERCUTANEOUS21 reports
- Armada B2080-040Catheter, angioplasty, peripheral, transluminal21 reports
- Armada 1013470-100Catheter, angioplasty, peripheral, transluminal21 reports
- Armada 1013470-120Catheter, angioplasty, peripheral, transluminal21 reports
- Armada B2050-040CATHETER, PERCUTANEOUS19 reports
- Armada A2030-040Catheter, angioplasty, peripheral, transluminal18 reports
- Armada 1013468-200Catheter, angioplasty, peripheral, transluminal17 reports
- Armada 1013470-080Catheter, angioplasty, peripheral, transluminal17 reports
- Armada B1050-080CATHETER, PERCUTANEOUS16 reports
- Armada B1060-060Catheter, angioplasty, peripheral, transluminal16 reports
- Armada B1060-080CATHETER, PERCUTANEOUS15 reports
- Armada B1090-040CATHETER, PERCUTANEOUS15 reports
- Armada B2050-060Catheter, angioplasty, peripheral, transluminal15 reports
- Armada B2060-100CATHETER, PERCUTANEOUS15 reports
- Armada 1013465-200Catheter, angioplasty, peripheral, transluminal15 reports
- Armada B1080-080Catheter, angioplasty, peripheral, transluminal14 reports
- Armada A2030-060Catheter, angioplasty, peripheral, transluminal14 reports
- Armada A2040-200Catheter, angioplasty, peripheral, transluminal14 reports
- Armada B2050-150CATHETER, PERCUTANEOUS13 reports
- Armada B2060-120CATHETER, PERCUTANEOUS13 reports
- Armada 1013468-100Catheter, angioplasty, peripheral, transluminal13 reports
- Armada B1050-060CATHETER, PERCUTANEOUS12 reports
- Armada B1120-060CATHETER, PERCUTANEOUS12 reports
- Armada B1140-040CATHETER, PERCUTANEOUS12 reports
- Armada B2050-120Catheter, angioplasty, peripheral, transluminal12 reports
- Armada B2070-060CATHETER, PERCUTANEOUS12 reports
- Armada B2070-100Catheter, angioplasty, peripheral, transluminal12 reports
- Armada B2070-150Catheter, angioplasty, peripheral, transluminal12 reports
- Armada A2040-120Catheter, angioplasty, peripheral, transluminal12 reports
- Armada F2015-020Catheter, angioplasty, peripheral, transluminal12 reports
- Armada B1040-040CATHETER, PERCUTANEOUS11 reports
- Armada B2060-020Catheter, angioplasty, peripheral, transluminal11 reports
- Armada B2060-080CATHETER, PERCUTANEOUS11 reports
- Armada B2070-200CATHETER, PERCUTANEOUS11 reports
- Armada B2100-040Catheter, angioplasty, peripheral, transluminal11 reports
- Armada A2020-080CATHETER, PERCUTANEOUS11 reports
- Armada F2020-020Catheter, angioplasty, peripheral, transluminal11 reports
- Armada 1013468-150Catheter, angioplasty, peripheral, transluminal11 reports
- Armada B1080-020Catheter, angioplasty, peripheral, transluminal10 reports
- Armada B1100-060Catheter, angioplasty, peripheral, transluminal10 reports
- Armada B2050-080CATHETER, PERCUTANEOUS10 reports
- Armada B2050-100CATHETER, PERCUTANEOUS10 reports
- Armada B2060-150Catheter, angioplasty, peripheral, transluminal10 reports
- Armada B2060-250CATHETER, PERCUTANEOUS10 reports
- Armada A2020-040Catheter, angioplasty, peripheral, transluminal10 reports
- Armada A2025-060Catheter, angioplasty, peripheral, transluminal10 reports
- Armada B2040-040Catheter, angioplasty, peripheral, transluminal9 reports
- Armada B2070-080CATHETER, PERCUTANEOUS9 reports
- Armada B2120-040Catheter, angioplasty, peripheral, transluminal9 reports
- Armada A2015-120Catheter, angioplasty, peripheral, transluminal9 reports
- Armada A2030-080Catheter, angioplasty, peripheral, transluminal9 reports
- Armada 1013465-060Catheter, angioplasty, peripheral, transluminal9 reports
- Armada 1013469-200Catheter, angioplasty, peripheral, transluminal9 reports
- Armada B1060-020CATHETER, PERCUTANEOUS8 reports
- Armada B1060-100Catheter, angioplasty, peripheral, transluminal8 reports
- Armada B2080-060CATHETER, PERCUTANEOUS8 reports
- Armada 1013470-040Catheter, angioplasty, peripheral, transluminal8 reports
- Armada 1013470-060Catheter, angioplasty, peripheral, transluminal8 reports
- Armada B1120-020Catheter, angioplasty, peripheral, transluminal7 reports
- Armada B1120-080Catheter, angioplasty, peripheral, transluminal7 reports
- Armada B2040-200Catheter, angioplasty, peripheral, transluminal7 reports
- Armada B2050-200Catheter, angioplasty, peripheral, transluminal7 reports
- Armada B2070-020Catheter, angioplasty, peripheral, transluminal7 reports
- Armada A2015-080Catheter, angioplasty, peripheral, transluminal7 reports
- Armada A2020-060CATHETER, PERCUTANEOUS7 reports
- Armada A2025-040Catheter, angioplasty, peripheral, transluminal7 reports
- Armada A2025-080Catheter, angioplasty, peripheral, transluminal7 reports
- Armada A2040-060CATHETER, PERCUTANEOUS7 reports
- Armada 1013465-100Catheter, angioplasty, peripheral, transluminal7 reports
- Armada B1060-150Catheter, angioplasty, peripheral, transluminal6 reports
- Armada B1070-020CATHETER, PERCUTANEOUS6 reports
- Armada B1070-100CATHETER, PERCUTANEOUS6 reports
- Armada B1100-020Catheter, angioplasty, peripheral, transluminal6 reports
- Armada B1100-080Catheter, angioplasty, peripheral, transluminal6 reports
- Armada B1140-060Catheter, angioplasty, peripheral, transluminal6 reports
- Armada B1140-080Catheter, angioplasty, peripheral, transluminal6 reports
- Armada B2070-120Catheter, angioplasty, peripheral, transluminal6 reports
- Armada B2120-060CATHETER, PERCUTANEOUS6 reports
- Armada F2012-020Catheter, angioplasty, peripheral, transluminal6 reports
- Armada 1013464-100Catheter, angioplasty, peripheral, transluminal6 reports
Recent Armada adverse event reports
The 15 most recent reports across all models, 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, 2026Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50938796 ↗MalfunctionSep 29, 2026Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50938364 ↗MalfunctionSep 29, 2026Leak/Splash; Improper or Incorrect Procedure or Method
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50936001 ↗MalfunctionSep 29, 2026Break; Inflation Problem; Leak/Splash
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50935933 ↗MalfunctionSep 14, 2026Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50759508 ↗MalfunctionAug 18, 2026Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50303200 ↗MalfunctionAug 6, 2026Inflation Problem; Leak/Splash
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50165144 ↗MalfunctionJun 22, 2026Material Rupture
IT WAS REPORTED THE PROCEDURE WAS TO TREAT AN UNKNOWN LESION. THE 8.0X20MM ARMADA 35 BALLOON DILATATION CATHETER WAS ADVANCED TO THE TARGET LESION HOWEVER WOULD NOT HOLD PRESSURE WHEN INFLATED DUE TO A HOLE IN THE BALLOON. 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 25579079 ↗MalfunctionJun 17, 2026Material Rupture
IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED SUPERFICIAL FEMORAL ARTERY LESION. A 6X200 MM ARMADA 35 LL BALLOON DILATATION CATHETER (BDC) WAS PREPARED BEFORE PATIENT USE. THE BDC WAS ADVANCED TO THE TARGET LESION FOR PRE-DILATION WITHOUT ISSUE. HOWEVER, DURING THE FIRST INFLATION, THE BALLOON RUPTURED AT 4 ATM. AN ADDITIONAL 6X200 MM ARMADA 35 LL 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 25539881 ↗MalfunctionJun 11, 2026Material Rupture; Difficult to Advance
IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LEFT VEIN GRAFT FOR A FISTULA GRAM. THE 7X60MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION WITH RESISTANCE DUE TO THE ANATOMY AND THE BALLOON WAS INFLATED; HOWEVER, THE BALLOON RUPTURED DURING THE INITIAL INFLATION AT 15 ATMOSPHERES (ATM). THEREFORE, THE BDC WAS REMOVED FROM THE PATIENT. 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 25480800 ↗MalfunctionJun 11, 2026Leak/Splash
IT WAS REPORTED THAT DURING PREPARATION OF THE 6X40MM ARMADA 35 BALLOON DILATATION CATHETER (BDC), A BALLOON LEAK WAS NOTED WHEN ATTEMPTING TO PULL NEGATIVE. THE BDC WAS NOT USED IN THE PROCEDURE. ANOTHER ARMADA BDC WAS USED TO CONTINUE THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25480709 ↗MalfunctionJun 10, 2026Material Rupture; Difficult to Advance
IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE LEFT BASILIC VEIN FISTULA WITH HEAVY CALCIFICATION AND HEAVY TORTUOSITY. THE 7X60MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION WITH RESISTANCE DUE TO THE ANATOMY. THE BALLOON WAS INFLATED; HOWEVER, THE BALLOON RUPTURED DURING THE INITIAL INFLATION AT 11 ATMOSPHERES (ATM). THEREFORE, THE BDC WAS REMOVED FROM THE PATIENT. A NON-ABBOTT BALLOON WAS USED TO CONTINUE THE PROCEDURE. 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 25462327 ↗MalfunctionJun 10, 2026Material Rupture
IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 60% STENOSED LESION IN THE COMMON ILIAC ARTERY WITH MODERATE CALCIFICATION. THE 4X40MM ARMADA 14 BALLOON DILATATION CATHETER (BDC) WAS USED IN THE PROCEDURE; HOWEVER, THE BALLOON BURST DURING THE FIRST INFLATION AT 6 ATMOSPHERES (ATM). ANOTHER ARMADA BDC WAS USED TO CONTINUE THE PROCEDURE. 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 25462275 ↗MalfunctionJun 10, 2026Material Rupture; Difficult to Advance
IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE COMMON ILIAC ARTERY WITH HEAVY CALCIFICATION, MILD TORTUOSITY AND 100% STENOSIS. THE 12X20 MM ARMADA 35 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER WAS ADVANCED AND RESISTANCE WAS NOTED WITH THE ANATOMY. THE BALLOON WAS INFLATED ONCE TO 8 ATMOSPHERES AND RUPTURED. ANOTHER ARMADA WAS USED 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 25460259 ↗
Other Abbott Vascular Inc. products
- MITRACLIP8 models · 5,973 reports · 2 recalls
- NC TREK56 models · 1,842 reports · 12 recalls
- Indeflator7 models · 1,196 reports · 9 recalls
- XIENCE Sierra56 models · 1,161 reports · 1 recall
- XIENCE Skypoint69 models · 1,142 reports
- Graftmaster15 models · 1,071 reports
- TREK50 models · 909 reports
- XIENCE ALPINE72 models · 898 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page