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U.S. Department of Health and Human Services

Medical Device Recalls
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1 to 7 of 7 Results
Recall Date to: 09/22/2014 PMA Number: P810046
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Product Description
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FDA Recall
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POWERSAIL Coronary Dilatation Catheter: 4.0x8mm (CE) Part #1005726-08 1 07/29/2009 Abbott Vascular-Cardiac Therapies dba Guidant Corporation
POWERSAIL Coronary Dilatation Catheter: 3.25x8mm (US) Part #1005524-08 1 07/29/2009 Abbott Vascular-Cardiac Therapies dba Guidant Corporation
POWERSAIL Coronary Dilatation Catheter: 2.75x18mm (US) Part #1005522-18 1 07/29/2009 Abbott Vascular-Cardiac Therapies dba Guidant Corporation
POWERSAIL Coronary Dilatation Catheter: 3.25x18mm (US) Part #1005524-18 1 07/29/2009 Abbott Vascular-Cardiac Therapies dba Guidant Corporation
VOYAGER NC Coronary Dilatation Catheter, 4.5 X 12.0 mm. The device is used for in the following: ... 2 02/03/2009 Abbott Vascular-Cardiac Therapies dba Guidant Corporation
VOYAGER NC Coronary Dilatation Catheter, 4.5 X 8.0 mm. The device is used for in the following: ... 2 02/03/2009 Abbott Vascular-Cardiac Therapies dba Guidant Corporation
Voyager RX Coronary Dilatation Catheter 2 04/13/2005 Guidant Corporation Advanced CardiovascularSystem
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