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Thoratec Corporation

Active in EUDAMED

United Statesfrom SRN EUDAMED FDA SRN US-MF-000010045 FEI 1218444

Devices
255
Registrations
EUDAMEDFDA
FDA recalls
33 ongoing

At a glance

Counted by deviCERTS from registry records

Market reach

European Union
EUDAMED actor
United States
FDA FEI, FDA recalls

Catalogue255

Newest first, rows 1-50 of 255

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Rows 1-50 of 255

Showing 1-50 of 255

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
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,…
      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.
      Submission number: P160054
    • 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,…
      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.
      Submission number: P160054
    • 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,…
      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.
      Submission number: P160054

Frequently asked questions

How many devices does Thoratec Corporation have in the registry?

The registry currently lists 255 devices for Thoratec Corporation. Devices recorded under merged duplicate company entries are counted once.

Which registries list Thoratec Corporation's devices?

Among its 50 most recently registered devices, Thoratec Corporation has devices listed in EUDAMED (28 devices) and FDA GUDID (26 devices). A device can be listed in more than one registry, so these counts overlap.

What risk classes do Thoratec Corporation's devices fall under?

Among its 50 most recently registered devices, the classes recorded for Thoratec Corporation's devices are Class I, Class III and active implantable (AIMDD). Each device page shows its own class and authorisation.

Are there FDA recall records for Thoratec Corporation?

FDA recall records list 3 recalls initiated by Thoratec Corporation, the most recent initiated on 13 May 2026. 3 of them are recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What are the newest devices from Thoratec Corporation in the registry?

The most recently registered devices listed for Thoratec Corporation include HEARTMATE®, Thoratec® HeartMate II®, Thoratec® HeartMate® and Thoratec® HeartMate III™.

Generated automatically from registry data and not verified by a human reviewer.