Category

Cardiac Devices Recalls

958 cardiac devices recalls on record from CPSC, FDA, and USDA.

958 recalls
High RiskFDA
Ge Healthcare, Llc
GE Healthcare, LOGIQ e Ultrasound System. The LOGIQ i/e and Vivid e is a general purpose ultrasound system intended for use by a qual...
Cardiac Devices·588 affected·Nov 9, 2012
High RiskFDA
Medrad Inc
MEDRAD Hand Controller Sheath, Catalog number AVA 500 HCS/3010903, for cardiac catheterization procedures. The Sterile Sheath is specifi...
Cardiac Devices·832,175 affected·Nov 5, 2012
High RiskFDA
Ge Healthcare It
Centricity Cardio Imaging 5.0 is a software only Picture Archiving and Communication System (PACS). Product Usage: It will be sold...
Cardiac Devices·1 affected·Oct 2, 2012
High RiskFDA
Greatbatch Medical
Biosense Webster MobiCath Bi-Directional Guiding Sheath. Small Curve catalog no. D140010, Large Curve catalog no. D140011. The MobiCath...
Cardiac Devices·9,040 affected·Sep 24, 2012
High RiskFDA
Mindray Ds Usa, Inc. D.b.a. Mindray North America
Mindray V12 Size: 320 mm X 320 mm X 450 mm N.W.: 3 kg G.W.: 6 kg Qty:1 Manufactured in China Mindray V21 Size: 515 mm X 335 mm X 685 ...
Cardiac Devices·206 affected·Sep 24, 2012
CriticalFDA
Heartsine Technologies, Limited
HeartSine Samaritan(R) 300/300P PAD devices with serial numbers 0400000501 to 0700032917; 08A00035000 to 10A0070753; 10C00200000 to 10C00...
Cardiac Devices·81,982 affected·Sep 13, 2012
High RiskFDA
Greatbatch Medical
Boston Scientific, Z Flex 270, Steerable Sheath, Sterile EO, Rx only, Distributed by Boston Scientific Corporation, One Boston Scientifi...
Cardiac Devices·787 affected·Sep 6, 2012
High RiskFDA
Zoll Medical Corporation
Zoll X Series Defibrillator/Pacemaker/Monitor Product Usage: The product is used by qualified medical personnel for the purpose of co...
Cardiac Devices·11 affected·Aug 16, 2012
High RiskFDA
Vital Images, Inc.
Software for Vitrea, Vitrea fX, and Vitrea Enterprise Suite (VES): VPMC-09293C Vitrea . Model Number Vitrea 5.2, 6.0, 6.1, and 6.2 ...
Cardiac Devices·2,088 affected·Aug 13, 2012
CriticalFDA
Philips Medical Systems (cleveland) Inc
Positron Emission Tomography (PET) and X-ray Computed Tomography, GEMINI TF 16 PET/CT, GEMINI GXL 16 PET/CT, GEMINI TF Big Bore PET/CT, ...
Cardiac Devices·7 affected·Aug 8, 2012
High RiskFDA
Philips Medical Systems North America Co. Phillips
Philips HeartStart FRx 861304 Automated External Defibrillator Manufactured by Philips Medical Systems, Seattle, WA 98121 USA; and Laerda...
Cardiac Devices·201,598 affected·Jul 26, 2012
High RiskFDA
Oscor, Inc.
Myocardial Heart Wires Intended for temporary atrial and ventricular pacing and sensing during or after cardiac surgery in conjunction...
Cardiac Devices·1,425 affected·Jul 25, 2012
RecallFDA
Abbott Point Of Care Inc.
Cliniqa Liquid QCTM Cardiac Marker Control for i-STAT Level 1 (List Number 06F12-09; Lot Number 071039) Cliniqa Liquid QCTM Cardiac Ma...
Cardiac Devices·154 affected·Jul 19, 2012
High RiskFDA
Siemens Medical Solutions Usa, Inc.
ACUSON SC2000 ultrasound systems at software versions VA20A or VA20B. Model number 10433816. The SC2000 ultrasound imaging system is ...
Cardiac Devices·476 affected·Jul 11, 2012
High RiskFDA
Philips Healthcare Inc.
Philips HeartStart MRx M3536A Defibrillator/Monitor with Software R.03.03 The Heartstart MRx is for use for the termination of ventric...
Cardiac Devices·35 affected·Jun 20, 2012
High RiskFDA
Philips Healthcare Inc.
Philips HeartStart MRx monitor/defibrillators Models: M3535A and M3536A, M3536J, M3536M, M3536MC, M3536M1, M3536M2, M3536M3, M3536M4, M3...
Cardiac Devices·58,701 affected·Jun 20, 2012
High RiskFDA
Philips Healthcare Inc.
Philips HeartStart MRx monitor/defibrillators Models: M3535A, M3536A, M3536M4, M3536M5, and M3536M6 Product Usage: The Heartstart MR...
Cardiac Devices·2,914 affected·Jun 20, 2012
High RiskFDA
Terumo Cardiovascular Systems Corporation
Sarns Modular Perfusion System 9000, 115V with color screen. The Sarns Perfusion System 9000 is indicated for use as a heart-lung syst...
Cardiac Devices·484 affected·Jun 18, 2012
High RiskFDA
Terumo Cardiovascular Systems Corporation
Sarns Modular Perfusion System 9000, 220/240V with color screen. The Sarns Perfusion System 9000 is indicated for use as a heart-lung ...
Cardiac Devices·286 affected·Jun 18, 2012
High RiskFDA
Maquet Cardiovascular Us Sales, Llc
QUADROX iD HMOD 2030 Diffusion Membrane Oxygenator; QUADROX-i ADULT HMO 70000 / HMO 71000; QUADROX-iD Pediatric HMOD 30000 Product U...
Cardiac Devices·23,203 affected·Jun 12, 2012
CriticalFDA
Alere San Diego, Inc.
Alere Triage Cardiac Panel PN 97000HS Used for the quantitative determination of creatine kinase MD (CK--MB), myoglobin and troponin I...
Cardiac Devices·6,044 affected·May 22, 2012
High RiskFDA
Terumo Cardiovascular Systems Corporation
Sarns Antegrade Cardioplegia Cannula: ROOT INFUSTION VENT CATHETER WITH 12 GAUGE BLUE NEEDLE RECTANGULAR FLANGE, 6" (15 CM) LONG Produ...
Cardiac Devices·53,139 affected·May 9, 2012
High RiskFDA
Terumo Cardiovascular Systems Corporation
X-COATED TRANSPLANT PACK Product Usage: The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are indicated for placement in...
Cardiac Devices·53,139 affected·May 9, 2012
High RiskFDA
Terumo Cardiovascular Systems Corporation
FX PACK Product Usage: The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are indicated for placement in the aortic root ...
Cardiac Devices·53,139 affected·May 9, 2012
High RiskFDA
Terumo Cardiovascular Systems Corporation
SARNS ANTEGRADE CARDIOPLEGIA CANNULA: ROOT INFUSION CANNULA WITH 12-GAUGE BLUE NEEDLE,RECTANGULAR FLANGE AND SUTURE COLLAR, 6" (15CM) LON...
Cardiac Devices·53,139 affected·May 9, 2012
High RiskFDA
Terumo Cardiovascular Systems Corporation
INDIANA/OHIO HEART Product Usage: The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are indicated for placement in the a...
Cardiac Devices·53,139 affected·May 9, 2012
High RiskFDA
Terumo Cardiovascular Systems Corporation
CPB CATHETER KIT-DR VANTRIGHT Product Usage: The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are indicated for placeme...
Cardiac Devices·53,139 affected·May 9, 2012
High RiskFDA
Terumo Cardiovascular Systems Corporation
SARNS ANTEGRADE CARDIOPLEGIA CANNULA: ROOT INFUSION CANNULA WITH 14-GAUGE WHITE NEEDLE,RECTANGULAR FLANGE AND SUTURE COLLAR, 6" (15CM) LO...
Cardiac Devices·53,139 affected·May 9, 2012
High RiskFDA
Terumo Cardiovascular Systems Corporation
X-COATED H/L PK W/FX15RW40 Product Usage: The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are indicated for placement ...
Cardiac Devices·53,139 affected·May 9, 2012
High RiskFDA
Terumo Cardiovascular Systems Corporation
CPB CATHETER KIT- DR HENDRICKSO Product Usage: The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are indicated for place...
Cardiac Devices·53,139 affected·May 9, 2012
High RiskFDA
Terumo Cardiovascular Systems Corporation
X-COATED SMALL PATIENT PACK Product Usage: The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are indicated for placement...
Cardiac Devices·53,139 affected·May 9, 2012
High RiskFDA
Mindray Ds Usa, Inc. D.b.a. Mindray North America
V Series Patient Monitors; Mindray DS USA, Inc. Product Usage: The V Series Monitor is intended for intra hospital use under the dire...
Cardiac Devices·979 affected·May 7, 2012
High RiskFDA
Ge Healthcare, Llc
GE Healthcare, Discovery MR750w 3.0T System. Part Number: 5352293. Product Usage: It is indicated for use as a diagnostic imaging d...
Cardiac Devices·46 affected·Apr 23, 2012
High RiskFDA
Steris Corporation
STERIS 5085 and 5085 SRT Surgical Tables, Product Usage: The 5085 is a general surgical table with high patient weight capacity, e...
Cardiac Devices·379 affected·Apr 6, 2012
RecallFDA
St Jude Medical Inc
Fast-Cath Transseptal Guiding Introducer, 90, 8F, REF 406586, Length 60 cm, Sterile EO, Rx only, St. Jude Medical, 14901 DeVeau Place, Mi...
Cardiac Devices·26 affected·Mar 28, 2012
High RiskFDA
Abbott Point Of Care Inc.
i-Stat BNP cartridges Abbott Point of Care Inc. The i-Stat BNP test is an in vitro diagnostic test for the quantitative measurement ...
Cardiac Devices·1,004,200 affected·Feb 1, 2012
High RiskFDA
Ge Healthcare, Llc
SIGNA INFINITY MR SYSTEM WITH EXCITE TECHNOLOGY GE 3.0T SIGNA INFINITY TWINSPEED WITH EXCITE MR SYSTEM GE SIGNA 3.0T WITH EXCITE MR SY...
Cardiac Devices·7,016 affected·Nov 21, 2011
High RiskFDA
Ge Healthcare, Llc
GE LightSpeed CT750 HD The GE LightSpeed CT750 HD Computed Tomography X-ray system is intended to produce cross-sectional images of th...
Cardiac Devices·244 affected·Apr 5, 2011
High RiskFDA
Mindray Ds Usa, Inc. D.b.a. Mindray North America
DPM 6/7 Patient Monitor Manufactured in China for : Mindray DS USA, Inc. 800 MacArthur Blvd. Mahwah, NJ 07430 USA. Intended to be...
Cardiac Devices·124 affected·Aug 11, 2010
High RiskFDA
Physio-control, Inc.
The LIFEPAK 15 monitor/defibrillator is intended for use by trained medical personnel in outdoor and indoor emergency care settings with...
Cardiac Devices·1,399 affected·Mar 11, 2010
High RiskFDA
Biosense Webster, Inc.
CARTO 3 V1.05(FG-5400-00). The CARTO 3 V1.05 System is intended for catheter-based atrial and ventricular mapping. The mapping system ...
Cardiac Devices·71 affected·Nov 17, 2009
High RiskFDA
Sagatech Electronics, Inc.
Finger Sensor for Remmers Recorder (Formerly SnoreSat Sleep recorder) To be used to gather heart rate and blood oxygen data during a s...
Cardiac Devices·152 affected·May 8, 2008
CriticalFDA
Ge Oec Medical Systems, Inc
OEC 9800; OEC FluoroTrak 9800 Plus; OEC 9800 Plus; OEC 9800 MD Motorized C-arm System, 892.1650 Image-intensified fluoroscopic x-ray syst...
Cardiac Devices·8,214 affected·Feb 22, 2008
High RiskFDA
Ge Oec Medical Systems, Inc
OEC 9800, OEC FluoroTrak 9800 Plus, OEC 9800 Plus, OEC 9800 MD Motorized C-arm System designed to provide fluoroscopic and spot-film imag...
Cardiac Devices·11,100 affected·Nov 19, 2007
High RiskFDA
Ge Oec Medical Systems, Inc
OEC 8800 Flexiview designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional p...
Cardiac Devices·1,349 affected·Nov 19, 2007
CriticalFDA
Ge Oec Medical Systems, Inc
OEC 8800 Flexview, 892.1650 Image-intensified fluoroscopic x-ray system Product Usage: The 8800 Flexview is designed to provide fl...
Cardiac Devices·1,257 affected·Nov 20, 2006