Abbott Vascular Inc.
FDA adverse event reports naming Abbott Vascular Inc. as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: ABBOTT VASCULAR INC..
- Total reports
- 24,268
- Deaths
- 175
- Injuries
- 17,759
- Malfunctions
- 6,252
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Top device categories
- Device, Hemostasis, VascularMGB17,117
- Coronary Drug-Eluting StentNIQ1,377
- Catheters, Transluminal Coronary Angioplasty, PercutaneousLOX1,054
- Wire, Guide, CatheterDQX1,005
- Catheter, Angioplasty, Peripheral, TransluminalLIT595
- Mitral Valve Repair DevicesNKM418
- Syringe, Balloon InflationMAV332
- Stent, IliacNIO329
- Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary BypassDTL282
- Stent, Superficial Femoral ArteryNIP266
Recent recalls
- 2024-12-20Open, ClassifiedComponent change control
20/30 INDEFLATOR, REF: 1000184, for use during cardiovascular procedures in conjunction with interventional devices such as balloon dilatation catheters to create and monitor pressure in the balloon.
Inflation Device used during cardiovascular procedures may leak in the indeflator at the hose rotating luer or at the gauge, which could lead to air embolism.
- 2024-12-20Open, ClassifiedComponent change control
20/30 Priority Pack Accessory Kit/.096 RHV, REF: 1000186, or use during vascular procedures in conjunction with interventional and / or diagnostic devices (e.g., balloon dilatation catheters, atherectomy devices, stent delivery systems, intravascular ultrasound devices).
Inflation Device used during cardiovascular procedures may leak in the indeflator at the hose rotating luer or at the gauge, which could lead to air embolism.
- 2024-12-20Open, ClassifiedComponent change control
20/30 Priority Pack Accessory Kit w/Copilot, REF: 1003327, used for cardiovascular procedures.
Inflation Device used during cardiovascular procedures may leak in the indeflator at the hose rotating luer or at the gauge, which could lead to air embolism.
- 2024-12-20Open, ClassifiedComponent change control
20/30 Priority Pack Kit/.115 RHV, REF: 1000186-115, used for cardiovascular procedures.
Inflation Device used during cardiovascular procedures may leak in the indeflator at the hose rotating luer or at the gauge, which could lead to air embolism.
- 2013-12-20TerminatedPending
HT Connect Peripheral Guide Wire Part Number Description 1012587 018 HT CONNECT 145 CM 1012588 018 HT CONNECT 195 CM 1012589 018 HT CONNECT 300 CM 1012590 018 HT CONNECT FLEX 145 CM 1012591 018 HT CONNECT FLEX 195 CM 1012592 018 HT CONNECT FLEX 300 CM 1012593 018 HT CONNECT 250T 145 CM 1012594 018 HT CONNECT 250T 195 CM 1012595 018 HT CONNECT 250T 300 CM
Abbott Vascular has initiated a recall of the HT Connect Peripheral Guide Wires due to a small number of devices exhibiting partial delamination of the PTFE coating.
- 2007-03-08TerminatedOther
StarClose Vascular Closure System (Clip Applier & Exchange System), Catalog Number: 14677; Product is manufactured by: Abbott Vascular Inc., 400 Saginaw Drive, Redwood City, CA 94063
Premature release of the vessel locator wings, which stabilize the device prior to clip deployment, will result in no hemostasis.
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