St Jude Medical
St Jude Medical appears in FDA public data with 41 recalls — including 12 Class I (most serious) —, 105 510(k) clearances, 4 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2073-2019, Class I) was initiated on June 20, 2019. Its most recent 510(k) clearance was granted on July 20, 2018.
Summary
- Total Recalls
- 41 (12 Class I)
- 510(k) Clearances
- 105
- Inspections
- 4
- Compliance Actions
- 0
Known Names
st. jude medical, st jude medical, st. jude medical systems, st. jude medical sweden
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-2073-2019 | Class I | ELLIPSE DR, REF: CD2377-36QC Implantable cardioverter defibrillators (ICDs) | June 20, 2019 |
| Z-2071-2019 | Class I | ELLIPSE VR, REF: CD1377-36QC Implantable cardioverter defibrillators (ICDs) | June 20, 2019 |
| Z-2072-2019 | Class I | ELLIPSE VR, Tiered-therapy cardioverter/defibrillator, REF: CD1411-36Q, UDI: 05414734507738 | June 20, 2019 |
| Z-2074-2019 | Class I | ELLIPSE DR, Tiered-therapy cardioverter/defibrillator, REF: CD2411-36C, UDI: 05414734507585 | June 20, 2019 |
| Z-2070-2019 | Class I | ELLIPSE VR, REF: CD1377-36C Implantable cardioverter defibrillators (ICDs) | June 20, 2019 |
| Z-2075-2019 | Class I | ELLIPSE DR, Tiered-therapy cardioverter/defibrillator, REF: CD2411-36Q, UDI: 05414734507615 | June 20, 2019 |
| Z-2320-2018 | Class II | Fortify, Sterile EO, Model #/ Part #: CD1231-40/100029238,100030095, 100041981; CD1231-40Q/10002 | April 16, 2018 |
| Z-2327-2018 | Class II | Unify Assura, Sterile EO, Model #/ Part #: CD3257-40/100042333, 100059944; CD3257-40Q/100042334, | April 16, 2018 |
| Z-2319-2018 | Class II | Ellipse, Sterile EO, Model #/ Part #: CD1275-36/100116115; CD1275-36Q/100116116; CD1277-36/1000 | April 16, 2018 |
| Z-2334-2018 | Class II | St. Jude Medical CONFIRM Rx Insertable Cardiac Monitor, Sterile EO, Model #: DM3500 The Confirm R | April 16, 2018 |
| Z-2328-2018 | Class II | Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, | April 16, 2018 |
| Z-2329-2018 | Class II | Merlin PCS programmer (Model # 3650), Software (Model # 3330) | April 16, 2018 |
| Z-2326-2018 | Class II | Unify, Sterile EO, Model #/ Part #: CD3231-40/100029240, 100030104, 100041904; CD3231-40Q/100029 | April 16, 2018 |
| Z-2335-2018 | Class II | Merlin PCS Programmer Software: 3330 The Merlin PCS programmer (model 3650) is a portable, extern | April 16, 2018 |
| Z-2322-2018 | Class II | Promote, Sterile EO, Model #/ Part #: 3207-30/60010740-207, 60010740-407; 3207-36/60010743-207, | April 16, 2018 |
| Z-2318-2018 | Class II | Current, Sterile EO, Model #/ Part #: 1207-30/50020236-001, 60010739-207, 60010739-407; 1207-36/5 | April 16, 2018 |
| Z-2324-2018 | Class II | Quadra Assura, Sterile EO, Model #/ Part #: CD3265-40/100042335, 100059846; CD3265-40Q/100042336, | April 16, 2018 |
| Z-2321-2018 | Class II | Fortify Assura, Sterile EO, Model #/ Part #: CD1257-40/100042322, 100059623; CD1257-40Q/10004234 | April 16, 2018 |
| Z-2325-2018 | Class II | Quadra Assura MP, Sterile EO, Model #/ Part #: CD3269-40/100043177; CD3269-40Q/100043178; CD32 | April 16, 2018 |
| Z-2323-2018 | Class II | Promote Quadra, Sterile EO, Model # / Part #: CD3221-36/100025054, 60019195; CD3223-36P/10001376 | April 16, 2018 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K181382 | GuardianTM Burr Hole Cover System | July 20, 2018 |
| K172396 | EnSite Velocity Cardiac Mapping System v5.2 | April 23, 2018 |
| K173232 | myMerlin(TM) Mobile Application Model APP1001 | November 2, 2017 |
| K160218 | AutoMark Module | December 13, 2016 |
| K160210 | EnSite Precision Cardiac Mapping System v2.0 | December 13, 2016 |
| K162643 | MediGuide Technology System | December 13, 2016 |
| K160335 | Advisor FL 15mm 12 Pole 333 Uni D, Advisor FL 20mm 12 Pole 555 Uni D, Advisor FL 15mm 12 Pole 333 Bi | December 13, 2016 |
| K161873 | Pacel Flow Directed Pacing Catheter | November 22, 2016 |
| K160187 | Ensite Velocity Cardiac Mapping System v5.0, Ensite Automap Module v1.0 | October 21, 2016 |
| K160186 | EnSite Velocity Surface Electrode Kit | October 7, 2016 |
| K152342 | Guardian Burr Hole Cover System, Guardian Screw, Burr Hole Cover | June 9, 2016 |
| K151911 | WorkMate Claris System, WorkMate Claris System Display Plus | October 22, 2015 |
| K152784 | Pacel Bipolar Pacing Catheters | October 22, 2015 |
| K151622 | St.Jude Medical MediGuide Enabled Livewire Steerable Electrophysiology Catheter, Livewire Electrophy | July 15, 2015 |
| K150631 | St. Jude Medical MediGuide Enabled Livewire Steerable Electroohysiology Catheter, Livewire Electroph | April 1, 2015 |
| K142235 | CPS Aim MediGuide Enabled inner catheter, CPS Aim Mediguide Enabled inner Catheter | December 18, 2014 |
| K142239 | CPS Direct MediGuide Enabled outer catheter | December 18, 2014 |
| K142254 | CPS Excel MediGuide Enabled Guidewire, CPS Excel MediGuide Torque clip, CPS Excel MediGuide Guidewir | November 13, 2014 |
| K141050 | ENSITE VELOCITY SYSTEM | June 6, 2014 |
| K140272 | SWIFT-LOCK ANCHOR | May 2, 2014 |