PlainRecalls

Cardiac Assist, Inc

Compiled from official public sources by the publisher.

14 recalls on record · Latest: Sep 6, 2023

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Agency notice ledger

Federal filing book Cardiac Assist, Inc LIGHT-BOOK · SINGLE-AGENCY

#1,079 of 14,151 · 14 notices · 0.013% archive

  • BOOK 14 notices
  • RANK #1,079 of 14,151
  • SHARE 0.013% archive
  • AGENCY FDA Devices (14)
  • CAT medical devices
  • CATS 1 category
  • LATEST Sep 6, 2023
  • PHOTO Actavis Elizabeth LLC

Nearest notice-volume peer: Actavis Elizabeth LLC (0 notice gap)

Cardiac Assist, Inc accounts for about 0.013% of the 104,423-notice archive on 14 distinct filings — a mid share signal beside absolute volume. FDA · CPSC · USDA FSIS · NHTSA notice stamps for this firm. Read with this firm → · Dominant category → · Similar-volume firm →

How Cardiac Assist, Inc compares to 14,151 recalling firms

Cardiac Assist, Inc ranks 1,079th of 14,151 tracked firms by distinct recall-event count. Archive size reflects filing volume, not inherent product danger.

Cardiac Assist, Inc vs all firms by recall-notice count

Where this firm's archive sits among every tracked recalling manufacturer

14 1079th of 14151 higher than 13,008 of 14,151 firms

Firms, banded by distinct federal recall-event inventory

Each bar is a band; taller bars hold more firms. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source FDA · CPSC · USDA FSIS · NHTSA federal recall filings · 2026-09-13

Cardiac Assist, Inc in the notice-volume neighbourhood

Distinct federal recall events among this firm and nearest nationwide peers

notices

What this shows Cardiac Assist, Inc holds about 0.013% of archive notices alongside 14 distinct filings.

Source FDA · CPSC · USDA FSIS · NHTSA filings aggregated by PlainRecalls As of September 2026
FDA Devices Moderate Sep 6, 2023

LifeSPARC Pump (part number 5800-0000) contained within TandemLife LifeSPARC Priming Tray part number: 5800-1000. Note: The 5800-1000 model number is an individually packaged component contained within the Kit numbers: 5830-2916 LS TANDEMLIFE KIT DL29 5840-2417 LS TANDEMLIFE KIT - V24, A17
FDA Devices Critical Jan 25, 2023

SHIP KIT, LIFESPARC, CONTROLLER AND ACCESSORIES - 5900-0000; SHIP KIT, LIFESPARC, CONTROLLER ONLY - 5900-0001. Component of LifeSPARC System, used to pump the blood through an extracorporeal circuit.
FDA Devices Critical Oct 5, 2022

TANDEM LIFE LivaNova LIFESPARC Controller; Controller and Accessories Model 5900-0000; Controller Only Model 5900-0001. For circulatory or cardiopulmonary bypass.
FDA Devices Low Dec 8, 2021

SHIP KIT, PROCEDURE KIT, PROTEKDUO LS - DL31 for temporary Cardiopulmonary bypass. Including the following components: a) 31 Fr ProtekDuo Veno-Venous Cannula Set b) LifeSPARC Pump c) 14Fr to 26 Fr Dilator Set d) TandemHeart Wrap. Kit Number: 5820-3118 Intended use is applicable to the intended use of specific devices included in the kit.
FDA Devices Moderate May 5, 2021

Protek Solo Venous Dilator Set: dilator, vessel, for percutaneous catheterization. Catalog #: 5840-2417 - LS Tandem Life Kit - V24/A17 Catalog #: 5840-2415 - LS Tandem Life Kit - V24/A15 Catalog #: 5740-2417 - TandemLife Kit - V24/A17 Catalog #: 5100-1422 - ProtekSolo Venous Dilator Set (14-22 Fr)
FDA Devices Moderate May 20, 2020

TandemHeart pump is assembled into kits: TandemLung Kit - DL31, Product: 5730-3118 - Product Usage: provides temporary extracorporeal circulatory system support with the unique ability to locally deliver an anticoagulant through the infusion system.
FDA Devices Moderate May 20, 2020

TandemHeart pump is assembled into kits: TandemHeart Kit - TS62/A17, Product: 5710-6217 - Product Usage: provides temporary extracorporeal circulatory system support with the unique ability to locally deliver an anticoagulant through the infusion system.
FDA Devices Moderate May 20, 2020

TandemHeart Pump Kit, Product: 5120-0000 - Product Usage: provides temporary extracorporeal circulatory system support with the unique ability to locally deliver an anticoagulant through the infusion system.
FDA Devices Moderate May 20, 2020

TandemHeart pump is assembled into kits: ProtekDuo Kit - DL29, Product: 5720-2916 - Product Usage: provides temporary extracorporeal circulatory system support with the unique ability to locally deliver an anticoagulant through the infusion system.
FDA Devices Moderate May 20, 2020

TandemHeart pump is assembled into kits: ProtekDuo Kit - DL3, Product: 5720-3118 - Product Usage: provides temporary extracorporeal circulatory system support with the unique ability to locally deliver an anticoagulant through the infusion system.
FDA Devices Moderate May 20, 2020

TandemHeart pump is assembled into kits: TandemLife Kit Product: 5740-0000 - Product Usage: provides temporary extracorporeal circulatory system support with the unique ability to locally deliver an anticoagulant through the infusion system.
FDA Devices Moderate May 20, 2020

TandemHeart pump is assembled into kits: ProtekDuo Kit - DL31 RD, Product: 5720-3631 - Product Usage: provides temporary extracorporeal circulatory system support with the unique ability to locally deliver an anticoagulant through the infusion system.
FDA Devices Moderate May 20, 2020

TandemHeart pump is assembled into kits: TandemHeart Kit - TS62/A15, Product: 5710-6215 - Product Usage: provides temporary extracorporeal circulatory system support with the unique ability to locally deliver an anticoagulant through the infusion system.
FDA Devices Moderate Feb 19, 2020

TandemLife ECLS Procedure Kit - V24/A17, Catalog Number 5740-2417 - Product Usage: The function of the 24Fr ProtekSolo Venous Cannula is to provide a conduit for blood to travel from the patient s venous system when connected to accessory extracorporeal equipment. The Venous Cannula is intended to cannulate vessels, perfuse vessels or organs and/or connect with accessory extracorporeal circulatory support equipment. The introducer is intended to facilitate proper insertion and placement of the

Cardiac Assist, Inc holds a measurable archive slice

Drug and device firms outside this manufacturer and state, matched by notice volume and category footprint.

Similar recall count

Nearest multi-notice firms by distinct-event totals (14 here — thin-book).

Actavis Elizabeth LLC 14 Albertsons Companies, Inc. 14 Allergan Sales, LLC 14 Aurolife Pharma, LLC 14 B&g Foods North America, Inc 14

Similar medical devices volume

Nearest multi-notice firms in the same narrow category lane.

Bd Switzerland Sarl 14 Biomet Spine, LLC 14 Cardinal Health, Medical Products & Services 14 Carefusion 211 Inc dba Carefusion 14

Frequently Asked Questions

How many federal recall notices name Cardiac Assist, Inc? ▼
PlainRecalls indexes 14 distinct federal recall events naming Cardiac Assist, Inc, aggregated from FDA, CPSC, USDA FSIS, and NHTSA filings (archive as of September 2026). That count is an issuance inventory, not a hazard score.
Where does Cardiac Assist, Inc sit among other recalling firms? ▼
Cardiac Assist, Inc ranks #1,079 of 14,151 by distinct recall-event count among 14,151 firms in this archive (92nd percentile of firms with fewer notices). Rank tracks filing frequency, not product danger.
Which agency issues most of Cardiac Assist, Inc's notices? ▼
FDA Devices accounts for 14 of this firm's 14 indexed notices.
What product category dominates Cardiac Assist, Inc's filing book? ▼
Filings for Cardiac Assist, Inc span 1 product category, led by medical devices. Browse that category archive for peer firms and related notices.
Is a higher notice count more dangerous? ▼
No. Archive size reflects how often federal agencies publish recalls naming the firm — reporting volume, coverage, and product range all move the number. Always verify the individual notice with the issuing agency before acting on a specific product.
Cardiac Assist, Inc: 14 federal recall notices aggregated from FDA, CPSC, USDA FSIS, and NHTSA filings (lead agency FDA Devices). Verify individual notices with FDA directly before acting on a specific recall.

Firm-level totals aggregate distinct federal recall events naming Cardiac Assist, Inc; individual notices remain authoritative on each linked recall page.

Methodology · Corrections · FDA · CPSC · USDA FSIS · NHTSA · Archive as of September 2026