PlainRecalls

SynCardia Systems Inc.

Compiled from official public sources by the publisher.

3 recalls on record · Latest: Dec 14, 2016

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Agency notice ledger

Federal filing book SynCardia Systems Inc. LIGHT-BOOK · SINGLE-AGENCY

#4,108 of 14,151 · 3 notices · 0.003% archive

  • BOOK 3 notices
  • RANK #4,108 of 14,151
  • SHARE 0.003% archive
  • AGENCY FDA Devices (3)
  • CAT medical devices
  • CATS 1 category
  • LATEST Dec 14, 2016
  • PHOTO 3B Medical, Inc.

Nearest notice-volume peer: 3B Medical, Inc. (0 notice gap)

SynCardia Systems Inc. accounts for about 0.003% of the 104,423-notice archive on 3 distinct filings — a light 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 SynCardia Systems Inc. compares to 14,151 recalling firms

SynCardia Systems Inc. ranks 4,108th of 14,151 tracked firms by distinct recall-event count. Archive size reflects filing volume, not inherent product danger.

SynCardia Systems Inc. vs all firms by recall-notice count

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

3 4108th of 14151 higher than 9,908 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

SynCardia Systems Inc. in the notice-volume neighbourhood

Distinct federal recall events among this firm and nearest nationwide peers

notices

What this shows SynCardia Systems Inc. holds about 0.003% of archive notices alongside 3 distinct filings.

Source FDA · CPSC · USDA FSIS · NHTSA filings aggregated by PlainRecalls As of September 2026
FDA Devices Critical Dec 14, 2016

5000 Series Freedom Drivers. Freedom Driver System for Temporary Total Artificial Heart (TAH-t). Part number 595000-001
FDA Devices Critical Sep 23, 2015

Temporary Total Artificial Heart (TAH-t) with Freedom Driver System REF 595000-001 Product Usage: Freedom Drivers are components of the SynCardia temporary Total Artificial Heart (TAH-t) System, which is indicated for use in transplant-eligible candidates at risk of imminent death from biventricular failure. Freedom Drivers are intended for use in and out of the hospital.
FDA Devices Moderate Jan 9, 2013

Companion External Battery, Part Number: 293001-001 The Companion External Battery is a component of the Companion 2 Driver System and the Companion Driver System. Both Driver Systems, with the temporary Total Artificial Heart (TAH-t) are indicated for use as a bridge to transplantation in cardiac transplant-eligible candidates at risk of imminent death from biventricular failure.

SynCardia Systems Inc. is a small archive contributor

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 (3 here).

3B Medical, Inc. 3 7-Eleven, Inc. 3 A & C Best Food Trading 3 A B Nutrition, Inc. 3 A L I Technologies Ltd 3

Similar medical devices volume

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

3B Medical, Inc. 3 A L I Technologies Ltd 3 Abeon Medical Corporation 3 Acist Medical Systems 3

Frequently Asked Questions

How many federal recall notices name SynCardia Systems Inc.? ▼
PlainRecalls indexes 3 distinct federal recall events naming SynCardia Systems 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 SynCardia Systems Inc. sit among other recalling firms? ▼
SynCardia Systems Inc. ranks #4,108 of 14,151 by distinct recall-event count among 14,151 firms in this archive (70th percentile of firms with fewer notices). Rank tracks filing frequency, not product danger.
Which agency issues most of SynCardia Systems Inc.'s notices? ▼
FDA Devices accounts for 3 of this firm's 3 indexed notices.
What product category dominates SynCardia Systems Inc.'s filing book? ▼
Filings for SynCardia Systems 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.
SynCardia Systems Inc.: 3 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 SynCardia Systems Inc.; individual notices remain authoritative on each linked recall page.

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