Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of AbbottLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 6 spellings of its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list Thoratec Corporation with 31 device recalls and 4 510(k) clearances. The most recent is a 510(k) clearance dated Jul 10, 2019: CentriMag Acute Circulatory Support System.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Date | Record | Source |
|---|---|---|
| Jul 10, 2019 | CentriMag Acute Circulatory Support SystemK191557 · DWA | 510(k) clearances |
| Mar 30, 2017 | HeartMate¿ II LVAS with Pocket Controller; 106762 - HMII POCKET CONTROLLER, NA; UDI: 00813024011286 Intended to provide hemodynamic suClass I · St. Jude Medical is providing all users of their HeartMate II LVAS with Pocket Controller with new software and updates | Device recalls |
| Mar 30, 2017 | HeartMate¿ II LVAS with Pocket Controller; 107801 - HMII PUMP & POCKET CTRL ONLY UDI:00813024011286 Intended to provide hemodynamic suClass I · St. Jude Medical is providing all users of their HeartMate II LVAS with Pocket Controller with new software and updates | Device recalls |
| Mar 30, 2017 | HeartMate¿ II LVAS with Pocket Controller; 106015 - HMII LVAD SEALED KIT-PCTRL, NA UDI: 00813024011224 Intended to provide hemodynamicClass I · St. Jude Medical is providing all users of their HeartMate II LVAS with Pocket Controller with new software and updates | Device recalls |
| Sep 18, 2015 | Thoratec CentriMag Return (Arterial) Cannula KitK152161 · DWF | 510(k) clearances |
| Sep 18, 2015 | Thoratec CentriMag Drainage (Venous) Cannula KitK152190 · DWF | 510(k) clearances |
| Mar 4, 2014 | HeartMate II System Controller Product Usage: HeartMate II is a mechanical device that circulates blood throughout the body when the heaClass I · Discovery of serious injuries and deaths associated with the process of changing from a primary System controller to the | Device recalls |
| Mar 4, 2014 | HeartMate II LVAD Pump and Pock Controller Kit; Product Usage: HeartMate II is a mechanical device that circulates blood throughout thClass I · Discovery of serious injuries and deaths associated with the process of changing from a primary System controller to the | Device recalls |
| Mar 4, 2014 | Heart Mate II Pocket Controllers removed from packaging Product Usage: HeartMate II is a mechanical device that circulates blood throuClass I · Discovery of serious injuries and deaths associated with the process of changing from a primary System controller to the | Device recalls |
| Mar 4, 2014 | HeartMate II Implant Kit with Pocket Controller; with sealed grafts (NAm) with sealed grafts (EU) Product Usage: HeartMate II is a mecClass I · Discovery of serious injuries and deaths associated with the process of changing from a primary System controller to the | Device recalls |
| Jul 18, 2013 | CENTRIMAG PRIMARY CONSOLE (2ND GENERATION); MAG MONITORK131179 · DWA | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
