Abbott Vascular-cardiac Therapies
FDA adverse event reports naming Abbott Vascular-cardiac Therapies as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: ABBOTT VASCULAR-CARDIAC THERAPIES.
- Total reports
- 6,221
- Deaths
- 471
- Injuries
- 3,468
- Malfunctions
- 2,277
Reports per year
Source: FDA adverse event reports by year received, 2004–2014. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Top device categories
- Coronary Drug-Eluting StentNIQ2,977
- Stent, CoronaryMAF2,029
- Catheters, Transluminal Coronary Angioplasty, PercutaneousLOX589
- Wire, Guide, CatheterDQX509
- Catheter, Coronary, AtherectomyMCX74
- Syringe, Balloon InflationMAV12
- Catheter, SteerableDRA11
- Catheter, Intravascular, DiagnosticDQO4
- Catheter, Angioplasty, Peripheral, TransluminalLIT3
- Catheter, PercutaneousDQY2
Recent recalls
- 2010-03-22TerminatedLabeling mix-ups
Peripheral Dilatation Catheter, Viatrac 14 Plus 5.0mm x 15mm x 80cm, Part Number 1008194-15. Manufactured by Abbott Vascular, Temecula, CA. Indicated to dilate stenosis in the peripheral vasculature and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
Abbott Vascular is initiating a recall on the Viatrac 14 Plus 5.0x15 mm Peripheral Dilation Catheter due to a mistake in labeling/packaging.
- 2010-03-16TerminatedPMA
Xact 9 mm x 20 mm x 136 cm (Part Number 82089-01) The Xact Carotid Stent System, used in conjunction with Emboshield Embolic Protection System is indicated for the improvement of the lumen diameter of carotid arteries in patients considered at high risk for adverse events from carotid endarterectomy who require percutaneous carotid angioplasty and stenting for occlusive artery disease.
Abbott Vascular is initiating a recall on the XACT Carotid Stent System because the product was distributed prior to approval of a PMA supplement for a manufacturing line move between sites. There are no product quality issues associated with this action.
- 2010-03-16TerminatedPMA
Xact 10 mm x 20 mm x 136 cm (Part Number 82099-01) The Xact Carotid Stent System, used in conjunction with Emboshield Embolic Protection System is indicated for the improvement of the lumen diameter of carotid arteries in patients considered at high risk for adverse events from carotid endarterectomy who require percutaneous carotid angioplasty and stenting for occlusive artery disease.
Abbott Vascular is initiating a recall on the XACT Carotid Stent System because the product was distributed prior to approval of a PMA supplement for a manufacturing line move between sites. There are no product quality issues associated with this action.
- 2010-01-29TerminatedProcess control
RX ACCULINK Carotid Stent System, 10x40 mm, Product Number: 1011344-40, Lot Number: 9081851. Indicated for the treatment of patients at high risk for adverse events from carotid endarterectomy who require carotid revascularization.
The recall was initiated after Abbott Vascular discovered, through internal testing, that the affected lot may not meet our quality specifications for catheter shaft tensile strength.
- 2009-07-29TerminatedProcess control
POWERSAIL Coronary Dilatation Catheter: 3.25x18mm (US) Part #1005524-18
Distal shaft of the POWERSAIL coronary Dilatation Catheters exhibits damage that may result in a leak of contrast material and functional failures.
- 2009-07-29TerminatedProcess control
POWERSAIL Coronary Dilatation Catheter: 4.0x8mm (CE) Part #1005726-08
Distal shaft of the POWERSAIL coronary Dilatation Catheters exhibits damage that may result in a leak of contrast material and functional failures.
- 2009-07-29TerminatedProcess control
POWERSAIL Coronary Dilatation Catheter: 2.75x18mm (US) Part #1005522-18
Distal shaft of the POWERSAIL coronary Dilatation Catheters exhibits damage that may result in a leak of contrast material and functional failures.
- 2009-07-29TerminatedProcess control
POWERSAIL Coronary Dilatation Catheter: 3.25x8mm (US) Part #1005524-08
Distal shaft of the POWERSAIL coronary Dilatation Catheters exhibits damage that may result in a leak of contrast material and functional failures.
- 2009-07-06TerminatedProcess design
Abbott Vascular, StarClose Vascular Closure System Part Number 14677-01, for closure of femoral artery access sites after cardiovascular catheterization.
Potential sterility issue. Internal component quarantined for possible contamination, was released for sale after going through sterilization procedure.
- 2009-02-03TerminatedPackage design/selection
VOYAGER NC Coronary Dilatation Catheter, 4.5 X 8.0 mm. The device is used for in the following: (1) Balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion, (2) Balloon dilatation of a coronary artery occlusion for the purpose of restoring coronary flow in patients with ST-segment elevation myocardial infarction, and (3) Balloon dilatation of a stent after implantation.
The recall was initiated after Abbott Vascular received reports the protective, yellow balloon sheath of the 4.5mm diameter VOYAGER NC Coronary Dilatation Catheter has been tight. If unnoticed by the user, there is a potential to cause damage to the balloon dilatation catheter during removal of the sheath. The balloon sheath covers the balloon, maintaining the fold configuration and protects the
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