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Cardiacassist, Inc.

United StatesFDA 510(k) applicant, unverified

Devices
87
FDA recalls
152 ongoing

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA recalls

What Cardiacassist, Inc. makes

CardiacAssist, Inc. manufactures a range of extracorporeal circulation components, including transseptal and femoral arterial cannula sets, venous cannula sets, a 15 Fr arterial cannula, a veno‑venous cannula, the TandemLung oxygenator, the LifeSPARC pump and controller system, the AB‑180 XC system, and the Tandem Heart Escort (T.H.E.) controller.

All of these devices are classified as Class II medical devices and are listed under the FDA 510(k) registry. CardiacAssist, Inc. is based in the United States.

AI-generated from registry data, 26 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue87

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Company details

DUNS number
948683941
Phone
18003737421

FDA recalls15

Recalls are matched to the firm by name. FDA recall data as of 22 Oct 2026.

FDA recall records list 15 recalls initiated by CARDIACASSIST, INC., the earliest on 2010-12-02 and the most recent on 2023-06-30. By recorded status: 2 ongoing and 13 terminated. The reasons filed fall into these groups: labeling or instructions for use, software or firmware, packaging and manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.

Generated automatically from FDA recall records, as a summary of the records listed below. It describes what the records state and is not an assessment of this manufacturer.

Recalls initiated per year

  • 2017 0
  • 2018 0
  • 2019 1
  • 2020 8
  • 2021 2
  • 2022 2
  • 2023 1
  • 2024 0
  • 2025 0
  • 2026 0

1 initiated before 2017

Showing the 10 most recent of 15 recalls.

  • 2023

    • 30 Jun 2023 Z-2465-2023 Class II Ongoing Epoxy used during manufacturing of the LifeSPARC Pump may have uncured epoxy. if undetectable curing may result in added risk of early pump failure, Distribution: US Nationwide distribution in the states of IL, FL. Submission number: K183623

  • 2022

    • 5 Dec 2022 Z-0926-2023 Class I Terminated A software update (v1.1.5) has been developed to address the issue of Critical Failure which can occur on the LifeSPARC Controller. The Critical Failure was first addressed in the firm's recall initiated July 21, 2022. During the Critical Failure, the software freezes or crashes and the screen does not display data. Distribution: US Nationwide distribution. Submission number: K183623
    • 21 Jul 2022 Z-1763-2022 Class I Terminated Critical Failure of the LifeSPARC controller when the software freezes or crashes and the screen does not display data. Distribution: US Nationwide distribution. Submission number: K183623

  • 2021

    • 14 Oct 2021 Z-0311-2022 Class III Ongoing Top label of the outer package of the collection kit Item 5820-3118 showed expiration date of 2022/05/01 (correct expiration date) while side label showed expiration date of 2021/05/01 (incorrect expiration date) Distribution: US Distribution to states of: DC, MA, SC, and VA. Submission number: K160257
    • 19 Mar 2021 Z-1486-2021 Class II Terminated On 02/26/2021, it was found that there were incorrectly packaged Dilator sets in Finished Goods. On 03/1/2021, it was confirmed that 14 kits containing the impacted products had been distributed to the field. Distribution: US Nationwide distribution in the states of AL, AZ, IL, TN. Submission number: K162181

  • 2020

    • 6 Mar 2020 Z-1948-2020 Class II Terminated Failure to prime due to an assembly error Distribution: US Nationwide distributions. Submission number: K110493
    • 6 Mar 2020 Z-1949-2020 Class II Terminated Failure to prime due to an assembly error Distribution: US Nationwide distributions. Submission number: K110493
    • 6 Mar 2020 Z-1950-2020 Class II Terminated Failure to prime due to an assembly error Distribution: US Nationwide distributions. Submission number: K110493
    • 6 Mar 2020 Z-1951-2020 Class II Terminated Failure to prime due to an assembly error Distribution: US Nationwide distributions. Submission number: K110493
    • 6 Mar 2020 Z-1952-2020 Class II Terminated Failure to prime due to an assembly error Distribution: US Nationwide distributions. Submission number: K110493
Show all 15 recalls

  • 2020

    • 6 Mar 2020 Z-1953-2020 Class II Terminated Failure to prime due to an assembly error Distribution: US Nationwide distributions. Submission number: K110493
    • 6 Mar 2020 Z-1954-2020 Class II Terminated Failure to prime due to an assembly error Distribution: US Nationwide distributions. Submission number: K110493
    • 6 Mar 2020 Z-1955-2020 Class II Terminated Failure to prime due to an assembly error Distribution: US Nationwide distributions. Submission number: K110493

  • 2019

    • 19 Nov 2019 Z-1106-2020 Class II Terminated The kit contained a 29Fr ProtekDuo cannula instead of a 24Fr Protek Solo Venous cannula. Distribution: US Nationwide distribution in the states of AZ, AL, ME, LA, PA. Submission number: K162214

  • 2010

    • 2 Dec 2010 Z-0889-2011 Unclassified (pre-2012) Terminated Component (Dilator of TandemHeart Transseptal Cannula Set-EF) does not meet specifications Distribution: Nationwide distribution including AZ, CA, CO, CT, DC, FL, GA, IL, LA, MA, MD, MI, MN, NC, NH, NJ, NY, OH, OK, OR, PA,…
      Full distribution text Nationwide distribution including AZ, CA, CO, CT, DC, FL, GA, IL, LA, MA, MD, MI, MN, NC, NH, NJ, NY, OH, OK, OR, PA, SC, TN, TX, VA, WA, and WI.
      Submission number: K052570

Frequently asked questions

How many devices does CARDIACASSIST, INC. have in the registry?

The registry currently lists 87 devices for CARDIACASSIST, INC.. Devices recorded under merged duplicate company entries are counted once.

Which registries list CARDIACASSIST, INC.'s devices?

Among its 50 most recently registered devices, CARDIACASSIST, INC. has devices listed in FDA GUDID (50 devices).

What risk classes do CARDIACASSIST, INC.'s devices fall under?

Among its 50 most recently registered devices, the classes recorded for CARDIACASSIST, INC.'s devices are Class I and Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for CARDIACASSIST, INC.?

FDA recall records list 15 recalls initiated by CARDIACASSIST, INC., the most recent initiated on 2023-06-30. 2 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 CARDIACASSIST, INC. in the registry?

The most recently registered devices listed for CARDIACASSIST, INC. include TandemHeart 2100-0113, LifeSPARC 5800-1000, TandemHeart 5150-0040 and TandemLife LifeSPARC 5840-2415.

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