Thoratec Corporation
Active in EUDAMEDUnited Statesfrom SRN EUDAMED FDA SRN US-MF-000010045 FEI 1218444
- Devices
- 255
- Registrations
- EUDAMED·FDA
- FDA recalls
- 33 ongoing
DeviceDevice · Authorizations Verified Status Regime Registry Class
- None Registry: GUDID ClassClass:III
- None Registry: GUDID ClassClass:II
- None Registry: GUDID ClassClass:III
- None Registry: GUDID ClassClass:III
- None Registry: GUDID ClassClass:III
- None Registry: GUDID ClassClass:III
- None Registry: GUDID ClassClass:II
- Active Regimes: CE AIMDD Registry: EUDAMEDGUDID ClassClass:III
- None Registry: GUDID ClassClass:III
- None Registry: GUDID ClassClass:III
- None Registry: GUDID ClassClass:III
- None Registry: GUDID ClassClass:III
- None Registry: GUDID ClassClass:III
- None Registry: GUDID ClassClass:III
- None Registry: GUDID ClassClass:III
- None Registry: GUDID ClassClass:III
- None Registry: GUDID ClassClass:III
- Active Regimes: CE AIMDD Registry: EUDAMEDGUDID ClassClass:III
- None Registry: GUDID ClassClass:III
- Active Regimes: CE AIMDD Registry: EUDAMEDGUDID ClassClass:III
- None Registry: GUDID ClassClass:III
- None Registry: GUDID ClassClass:III
- None Registry: GUDID ClassClass:III
- None Registry: GUDID ClassClass:III
- None Registry: GUDID ClassClass:III
- None Registry: GUDID ClassClass:II
- Active Regimes: CE AIMDD Registry: EUDAMEDGUDID ClassClass:III
- None Registry: GUDID ClassClass:II
- None Registry: GUDID ClassClass:III
- None Registry: GUDID ClassClass:III
- None Registry: GUDID ClassClass:III
- None Registry: GUDID ClassClass:III
- Active Regimes: CE AIMDD Registry: EUDAMEDGUDID ClassClass:III
- None Registry: GUDID ClassClass:III
- None Registry: GUDID ClassClass:III
- None Registry: GUDID ClassClass:III
- Active Regimes: CE AIMDD Registry: EUDAMEDGUDID ClassClass:III
- Active Regimes: CE AIMDD Registry: EUDAMEDGUDID ClassClass:III
- Active Regimes: CE MDR Registry: EUDAMEDGUDID ClassClass:I
- Active Regimes: CE AIMDD Registry: EUDAMEDGUDID ClassClass:III
- None Registry: GUDID ClassClass:III
- None Registry: GUDID ClassClass:III
- None Registry: GUDID ClassClass:II
- None Registry: GUDID ClassClass:III
- Active Regimes: CE MDR Registry: EUDAMEDGUDID ClassClass:I
- Withdrawn Registry: GUDID ClassClass:III
- None Registry: GUDID ClassClass:III
- None Registry: GUDID ClassClass:III
- None Registry: GUDID ClassClass:III
- None Registry: GUDID ClassClass:III
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Company details
- EUDAMED SRN
- US-MF-000010045
- FDA FEI number
- 1218444
- DUNS number
- 070156955
- EUDAMED status
- Active
- EUDAMED registered name
- Thoratec Corporation
- Registered address
- 6035, Stoneridge Drive, 94588, Pleasanton, California, United States
- Website
- www.abbott.com
- linkedin.com/company/1612
- facebook.com/Abbott
- [email protected]
- Phone
- +1(855)478-5833
- PRRC contact
- Carolyn Tabion(public in EUDAMED)
FDA recalls3
Recalls are matched to the firm by name. FDA recall data as of 1 Nov 2026.
Recalls initiated per year
- 2017 0
- 2018 0
- 2019 0
- 2020 0
- 2021 0
- 2022 0
- 2023 0
- 2024 0
- 2025 0
- 2026 3
2026
- 13 May 2026 Z-2518-2026 Class II Ongoing Due to 11 volt Backup Battery failures. Distribution: Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, DC, DE, FL, GA, IA, IL, IN, KS, KY,…Submission number: P160054
Full distribution text
Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NJ, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI and the countries of Canada, Germany, Japan, Netherlands, Poland, Spain. - 13 May 2026 Z-2519-2026 Class II Ongoing Due to 11 volt Backup Battery failures. Distribution: Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, DC, DE, FL, GA, IA, IL, IN, KS, KY,…Submission number: P160054
Full distribution text
Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NJ, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI and the countries of Canada, Germany, Japan, Netherlands, Poland, Spain. - 13 May 2026 Z-2520-2026 Class II Ongoing Due to 11 volt Backup Battery failures. Distribution: Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, DC, DE, FL, GA, IA, IL, IN, KS, KY,…Submission number: P160054
Full distribution text
Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NJ, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI and the countries of Canada, Germany, Japan, Netherlands, Poland, Spain.
- 13 May 2026 Z-2518-2026 Class II Ongoing Due to 11 volt Backup Battery failures. Distribution: Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, DC, DE, FL, GA, IA, IL, IN, KS, KY,…