PlainRecalls

Heartware

Compiled from official public sources by the publisher.

3 recalls on record · Latest: Jun 6, 2018

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Agency notice ledger

Federal filing book Heartware LIGHT-BOOK · SINGLE-AGENCY

#3,659 of 14,151 · 3 notices · 0.003% archive

  • BOOK 3 notices
  • RANK #3,659 of 14,151
  • SHARE 0.003% archive
  • AGENCY FDA Devices (3)
  • CAT medical devices
  • CATS 1 category
  • LATEST Jun 6, 2018
  • PHOTO 3B Medical, Inc.

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

Heartware 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 →

Where Heartware sits among 14,151 recalling firms

Heartware ranks 3,659th of 14,151 tracked firms by distinct recall-event count. Archive size reflects filing volume, not inherent product danger.

Heartware vs all firms by recall-notice count

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

3 3659th 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 · 2026-09-16

Heartware in the notice-volume neighbourhood

Distinct federal recall events among this firm and nearest nationwide peers

notices

What this shows Heartware 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 Jun 6, 2018

Heartware Medtronic HVAD System for cardiac use. Including the following parts: (a) Controller / Controller Kits, Product numbers: 1400, 1401, 1403, 1407, 1420 (b) DC Adapter, Product numbers: 1435, 1440 (c) AC Adapter, Product numbers: 1425, 1430 (d) Battery Pack, Product number: 1650DE Indication for Use for OUS HVAD System: The HVAD System is intended for use in patients at risk of death from refractory end-stage heart failure. The HVAD System is designed for in-hospital and out-
FDA Devices Critical May 3, 2017

HeartWare Ventricular Assist System (HVAD) Pump Driveline Splice Kit Product Usage: Is intended to repair the driveline cable once an electrical break has been identified. These repairs are limited to the portion of the driveline that is outside the patient boundary (exit side).
FDA Devices Critical May 3, 2017

HeartWare HVAD System Controller The HeartWare Ventricular Assist System (VAS is indicated for use as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure. The HeartWare Ventricular Assist System (VAS) is designed for in-hospital and out-of-hospital settings, including transportation via fix-wing aircraft or helicopter

Heartware 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 Heartware? ▼
PlainRecalls indexes 3 distinct federal recall events naming Heartware, 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 Heartware sit among other recalling firms? ▼
Heartware ranks #3,659 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 Heartware's notices? ▼
FDA Devices accounts for 3 of this firm's 3 indexed notices.
What product category dominates Heartware's filing book? ▼
Filings for Heartware 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.
Heartware: 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 Heartware; individual notices remain authoritative on each linked recall page.

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