St. Jude Medical, Inc.
St. Jude Medical, Inc. holds FDA 510(k) medical device clearances, first cleared 1989, most recent 2018, with 51 FDA device recalls on record.
Top product codes for St. Jude Medical, Inc.
FDA recalls by St. Jude Medical, Inc.
10 most recent of 51- Z-2073-2019 — ELLIPSE DR, REF: CD2377-36QC Implantable cardioverter defibrillators (ICDs)
- Z-2074-2019 — ELLIPSE DR, Tiered-therapy cardioverter/defibrillator, REF: CD2411-36C, UDI: 05414734507585
- Z-2072-2019 — ELLIPSE VR, Tiered-therapy cardioverter/defibrillator, REF: CD1411-36Q, UDI: 05414734507738
- Z-2075-2019 — ELLIPSE DR, Tiered-therapy cardioverter/defibrillator, REF: CD2411-36Q, UDI: 05414734507615
- Z-2070-2019 — ELLIPSE VR, REF: CD1377-36C Implantable cardioverter defibrillators (ICDs)
- Z-2071-2019 — ELLIPSE VR, REF: CD1377-36QC Implantable cardioverter defibrillators (ICDs)
- Z-0593-2019 — St. Jude Medical InfinityTM DBS System 8CH Directional Lead, 30 cm, 0.5 REF 6170 - STERILE EO Rx ONLY CE 0086 0123 St. Jude Medical Plano, TX St. Jude Medical InfinityTM DBS System 8CH Directional Lead, 40 cm, 0.5 REF 6172 STERILE EO Rx ONLY St. Jude Medical Plano, TX Instructions For Use: Lead and Extension Kits for Deep Brain Stimulation Systems Clinician's Manual ST. JUDE MEDICAL - Product Usage: St. Jude Medical Deep Brain Stimulation (DBS)leads are intended to deliver stimulation to target areas in the brain. DBS extensions are intended to connect the leads to implantable pulse generators (IPGs). St. Jude Medical DBS leads are designed for introduction into the brain using standard stereotactic neurosurgical techniques. DBS system delivers electrical stimulation to a precisely targeted area in the brain. Leads are implanted in the brain and are connected to extensions, which are passed under the skin and are connected to the neurostimulator. Leads for the St. Jude Medical Infinity DBS System feature electrodes on a stiff distal end with an inactive lead tip. The proximal end of the lead contains contact bands that correspond with each of the distal electrodes and an inactive band that functions as a contact for a setscrew when connecting to a compatible extension. The 8-channel leads contain cylindrical and segmented electrodes. The segmented electrodes can be activated independently to focus stimulation in one direction to help target desired neurological structures. As stated in Clinician manual (ARTEN600008305 Rev A), leads materials which are intended to come into contact with tissue are Platinum-iridium and polycarbonate urethane. In addition, drawing for the Stim Tip, 1-3-3-1 Directional DBS lead requires that the electrode material shall be 90/10 Platinum Iridium.
- Z-2335-2018 — Merlin PCS Programmer Software: 3330 The Merlin PCS programmer (model 3650) is a portable, external device used to support the implanted device, and for this recall the software that resides on the programmer (software model 3330) is the method of delivery of the new firmware.
- Z-2334-2018 — St. Jude Medical CONFIRM Rx Insertable Cardiac Monitor, Sterile EO, Model #: DM3500 The Confirm Rx ICM 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.
- Z-2320-2018 — Fortify, Sterile EO, Model #/ Part #: CD1231-40/100029238,100030095, 100041981; CD1231-40Q/100029229, 100030087, 100041982; CD1233-40/100029230, 100029250, 100029259,100031058, 100059778, 100070017; CD1233-40Q/100029260, 100029271, 100029277, 100031104, 100070089; CD1235-40/100029272, 100029282, 100029311, 100031039, 100059779; CD1235-40Q/100029273, 100029295, 100029312, 100030840; CD1241-40/100046351; CD1241-40Q/100046167; CD2231-40/100029274, 100030110, 100041922; CD2231-40Q/100029275, 100030089, 100041923; CD2233-40/100029147, 100029276, 100029313, 100031066, 100037043, 100048759, 100070007; CD2233-40Q/100029148, 100029263, 100029314, 100031067, 100037044, 100059770, 100070068; CD2235-40/100029149, 100029265, 100029283, 100031029, 100059837; CD2235-40Q/100029239, 100029258, 100029284, 100031030, 100066504; CD2241-40/100046148; CD2241-40Q/100046149; CD2299-40/100056952
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by St. Jude Medical, Inc.
- K172393 — Advisor HD Grid Mapping Catheter, Sensor Enabled
- K163407 — Confirm Rx Insertable Cardiac Monitor (ICM) System
- K161171 — PressureWire X Guidewire
- K161102 — Nanostim Introducer Kit
- K160716 — The Nanostim Introducer Kit
- K140793 — NANOSTIM INTRODUCER KIT
- K133481 — SJM CONFIRM IMPLANTABLE CARDIAC MONITOR (ICM)
- K131592 — ENLIGHTN RENAL GUIDE CATHETER
- K073700 — 6F PROXIS SYSTEM
- K042734 — SJM RIGID SADDLE RING MODEL RSAR-(SIZE)
- K022363 — SJM TAILOR ANNULOPLASTY BAND, MODEL TAB-(SIZE) (TAILOR BAND)
- K014161 — SJM TAILOR ANNULOPLASTY RING MODEL TARP- (SIZE)
- K014037 — SJM SEGUIN ANNULOPLASTY RING (SEGUIN RING), MODEL SARP-(SIZE)
- K001367 — FAST-CATH 18F HEMOSTASIS INTRODUCER, MODEL 406XXX
- K001346 — ULTIMUM HEMOSTASIS INTRODUCER, MODEL 4076XX
- K000119 — SJM TAILOR ANNULOPLASTY RING, MODEL TARN
- K961246 — SJM SEGUIN ANNULOPLASTY RING MODEL SAR-M
- K935184 — REDIFURL AND TEPERSEAL DL INTRA-AORTIC BALLOON CATHETERS WITH HYDROMER COATING
- K933014 — LIFESTREAM CENTRIFUGEL PUMP INTERFACE #210PI
- K921550 — LIFESTREAM CENTRIFUGAL PUMP SYSTEM MODEL 2100CP
- K902159 — BIFLEX(TM) ANNULOPLASTY RING
- K900379 — HYCULT DIAMOND CORONARY BYPASS KNIFE
- K894255 — ST.JUDE MEDICAL PULSE 2100 CENTRIFUGAL PUMP
Data sourced from openFDA. This site is unofficial and independent of the FDA.