254 results
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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St. Jude Medical, Fixed Curve Response 6F Electrophysiology Catheter, CSL, Model 401353
FDA Enforcement
Class II
·Terminated·St Jude Medical·November 12, 2014
Fast-Cath Transseptal Guiding Introducer, 90, 8F, REF 406586, Length 60 cm, Sterile EO, Rx only, St. Jude Medical, 14901 DeVeau Place, Minnetonka, MN 55343 Indicated for introducing various cardiovascular catheters into the left side of the heart through the interatrial septum.
FDA Enforcement
Class III
·Terminated·St Jude Medical Inc·January 9, 2013
St Jude Medical, 10F Fast-Cath Trio" Hemostasis Introducer, REF # 406308, Sterile EO. The Fast-Cath Trio" Hemostasis Introducer consists of the following components: Port hemostasis adapter (3), Sheath (10F Cath-Lock"), dilator (10F) and 0.038 guidewire. See product labeling for diagram of contents.
FDA Enforcement
Class II
·Terminated·St Jude Medical·October 29, 2014
St. Jude Medical Merlin PCS Programmer, used in combination with St. Jude Medical bradycardia and tachycardia devices. Model 3650
FDA Recall
Terminated
·St Jude Medical CRMD·Product code KRG·October 6, 2006
St. Jude Medical APS III Programmer, used in combination with St. Jude Medical bradycardia and tachycardia devices. Model 3500/3510
FDA Recall
Terminated
·St Jude Medical CRMD·Product code KRG·October 6, 2006
St. Jude Medical Identity SR Model 5172, Identity DR Model 5370, & Identity XL DR Model 5376; Pulse Generators (pacemakers)
FDA Recall
Terminated
·St Jude Medical CRMD·Product code DXY·October 6, 2006
MitraXs" Self Adjusting Atrial Retractor, Sterile EO, Models (REF): A0030/1; A0031/1; A0032/1; A0033/1, Cardio Life Research s.a., Green Hill, Hoge Wei, 16, B-1930 Zaventem, Belgium. Indicted for the retraction of the atrium walls during mitral or tricuspid cardiac surgery.
FDA Recall
Terminated
·St. Jude Medical Cardiovascular Division·Product code DWS·January 26, 2011
St. Jude Medical Confirm Rx Insertable Cardiac Monitor, REF DM3500, Sterile. Product Usage: The St. Jude Medical Confirm Rx insertable cardiac monitor (ICM) is designed to detect arrhythmias and wirelessly transmit data to the Merlin.net Patient Care Network (PCN). It is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for cardiac arrhythmias. It is also indicated for patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation.
FDA Enforcement
Class II
·Terminated·Abbott·May 1, 2019
Merlin@home RF Remote Monitoring Transmitter, Model EX1150, with software versions 6.1M or 7.0. Usage:RF Remote Transmitter
FDA Recall
Terminated
·St Jude Medical Cardiac Rhythm Management Division·Product code NVZ·December 18, 2014
St. Jude Medical FAST-CATH Hemostasis Introducer 7F, REF 406702, Length 12 CM, Lot 6372 Max. Guidewire O.D. .038", 2010-01, Manufacturer, St. Jude Medical, 14901 DeVeau place, Minnetonka, MN 55345-2126, Sterile EO. Used for the introduction of catheters into a vessel.
FDA Recall
Terminated
·St. Jude Medical·Product code DQX·August 17, 2009
St. Jude Medical FAST-CATH Hemostasis Introducer 4F, REF 406709, Length 12 CM, Lot 4219 Max. Guidewire O.D. .038", 2010-01, Manufacture, St. Jude Medical, 14901 DeVeau place, Minnetonka, MN 55345-2126, Sterile EO. Used for the introduction of catheters into a vessel.
FDA Recall
Terminated
·St. Jude Medical·Product code DQX·August 17, 2009
The St. Jude Medical Livewire TC" Ablation Catheter, 8mm Tip w/Thermocouple & Thermistor REF 402196, Length 115 cm, Lot 2056960, Manufacturer St. Jude Medical 14901 DeVeau Place, Minnetonka, MN 55345-2126 USA, Sterile EO The St. Jude Medical Livewire TC" Ablation Catheter is a flexible electrode catheter constructed of a radiopaque polyurethane insulation/shaft and incorporated platinum electrode. The distal tip portion may be deflected by a remote control handle located a t the proximal end of t the catheter.
FDA Recall
Terminated
·St. Jude Medical Cardiovascular Division·Product code LPB·June 5, 2008
St. Jude Medical, Fixed Curve Response 6F Electrophysiology Catheter, CSL, Model 401353
FDA Recall
Terminated
·Product code DRF·October 14, 2014
St. Jude Medical, Engage TR Introducer, 6 F - ACT (2.25 mm), 12 cm length, .025" Max Guidewire O.D., Rx, Sterile EO, REF C408527, 100028094.
FDA Recall
Terminated
·St. Jude Medical Cardiovascular Division·Product code DYB·June 28, 2010
St. Jude Medical, Engage TR Introducer, 6 F - ACT (2.25 mm), 12 cm length, .035" Max Guidewire O.D., Rx, Sterile EO, REF C408502, 100017543.
FDA Recall
Terminated
·St. Jude Medical Cardiovascular Division·Product code DYB·June 28, 2010
St. Jude Medical, Engage TR Introducer, 6 F - ACT (2.25 mm), 12 cm length, .038" Max Guidewire O.D., Rx, Sterile EO, REF C408507,100017564.
FDA Recall
Terminated
·St. Jude Medical Cardiovascular Division·Product code DYB·June 28, 2010
St Jude Medical, 10F Fast-Cath Trio" Hemostasis Introducer, REF # 406308, Sterile EO. The Fast-Cath Trio" Hemostasis Introducer consists of the following components: Port hemostasis adapter (3), Sheath (10F Cath-Lock"), dilator (10F) and 0.038 guidewire. See product labeling for diagram of contents.
FDA Recall
Terminated
·Product code DYB·October 14, 2014
St. Jude Medical, Engage TR Introducer, 6 F - ACT (2.25 mm), 25 cm length, .035" Max Guidewire O.D., Rx, Sterile EO, REF C408513, 100017549.
FDA Recall
Terminated
·St. Jude Medical Cardiovascular Division·Product code DYB·June 28, 2010
St. Jude Medical, Engage TR Introducer, 6 F - ACT (2.25 mm), 7 cm length, .025" Max Guidewire O.D., Rx, Sterile EO, REF C408524, 100028093.
FDA Recall
Terminated
·St. Jude Medical Cardiovascular Division·Product code DYB·June 28, 2010
Eon Mini - 3721 (Charger). Product Usage: Eon Mini system is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs including unilateral or bilateral pain associated with the following: failed back surgery syndrome, intractable low back and leg pain.
FDA Recall
Terminated
·St. Jude Medical·Product code LGW·July 26, 2012