Medtronic Inc. Cardiac Rhythm Disease Management

FDA Regulatory Profile

Summary

Total Recalls
23 (1 Class I)
510(k) Clearances
0
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0022-2016Class IIMedtronic Medical Device Identification Card for SureScan pacemaker patients. The front of September 15, 2015
Z-2777-2015Class IIMedtronic CryoConsole, models 106A3, 106E2, and 106A2-K For use in performing cardiac ablation procSeptember 1, 2015
Z-1365-2015Class IICovidien Trellis 6 and Trellis 8 Peripheral Infusion Systems, Sterile EO, Rx only. Models BVT608010VMarch 23, 2015
Z-1356-2015Class IIMedtronic Dual Chamber Temporary External Pacemaker, Model 5392. Product Usage: The temporary March 17, 2015
Z-1276-2015Class IMedtronic, 10 Fr FlexCath Select Steerable Sheath 990065. The FlexCath Select Steerable SheatFebruary 23, 2015
Z-1661-2014Class IIMedtronic Temporary Pacemaker, Model 5348. Single Chamber External Pulse Generator (EPG) Temporary PApril 29, 2014
Z-0997-2014Class IIMedtronic Select 3D Arterial Cannulae. Vented, model 78624 (24 Fr.). Non-Vented Cannulae, model 7January 30, 2014
Z-0999-2014Class IIMedtronic Select CAP Arterial Cannulae. Non-Vented, Carmeda Coated, model CB78722 (22 Fr.). SterilJanuary 30, 2014
Z-0996-2014Class IIMedtronic Select 3D Arterial Cannulae. Vented, model 78622 (22 Fr.). Non-Vented Cannulae, model 7January 30, 2014
Z-0998-2014Class IIMedtronic Select CAP Arterial Cannulae. Vented, models 78818 (18 Fr.), 78820 (20 Fr.), 78822 (22 FJanuary 30, 2014
Z-1000-2014Class IIMedtronic Intersept Custom Tubing Pack which contain Select 3D or Select CAP Arterial Cannulae. ModJanuary 30, 2014
Z-0995-2014Class IIMedtronic Select 3D Arterial Cannulae. Vented, models 78618 (18 Fr.) and 78620 (20 Fr.). Non-VentJanuary 30, 2014
Z-2104-2013Class IIMedtronic Custom Perfusion System. Model Numbers: 1D80R8, 1E34R1, 1F75R1, 1G49R2, 1G75R1, 1P07R8, July 17, 2013
Z-2105-2013Class IIMedtronic Custom Perfusion System with Carmeda BioActive Surface. Model Numbers: CB1D82R12 and CB5July 17, 2013
Z-2106-2013Class IIMedtronic Custom Perfusion System with Trillium BioSurface (a polymer containing non-leaching hepariJuly 17, 2013
Z-1876-2013Class IIMedtronic Mullins Transseptal Adult 7F, REF 008551. Intended for the introduction of cardiovascuJuly 8, 2013
Z-1966-2013Class IIMedtronic Affinity Pediatric Arterial Filter, model number S4014, sterilized using ethylene oxide. June 14, 2013
Z-1564-2013Class IIMedtronic, Launcher Guiding Catheter, Model # LA8EBU45SH, Lot # 0006722866, 8F and Model # LA6IMAD,June 12, 2013
Z-1607-2013Class IIMedtronic, Consulta¿ CRT-P, Model C4TR01, C3TR01 (not approved for US), and Syncra¿ CRT-P, Model CJune 7, 2013
Z-1017-2013Class IIMedtronic Archer Super Stiff Guidewire 0.035 inch (0.89mm), Model ARCSJ200W. Intended to facilitaMarch 13, 2013