PlainRecalls

Heartware, Inc.

Compiled from official public sources by the publisher.

72 recalls on record · Latest: Dec 13, 2023

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Agency notice ledger

Federal filing book Heartware, Inc. MID-BOOK · SINGLE-AGENCY

#246 of 14,151 · 72 notices · 0.069% archive

  • BOOK 72 notices
  • RANK #246 of 14,151
  • SHARE 0.069% archive
  • AGENCY FDA Devices (72)
  • CAT medical devices
  • CATS 1 category
  • LATEST Dec 13, 2023
  • PHOTO McCain Foods USA

Nearest notice-volume peer: McCain Foods USA (0 notice gap)

Heartware, Inc. accounts for about 0.069% of the 104,423-notice archive on 72 distinct filings — a heavy 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, Inc. sits among 14,151 recalling firms

Heartware, Inc. ranks 246th of 14,151 tracked firms by distinct recall-event count. Archive size reflects filing volume, not inherent product danger.

Heartware, Inc. vs all firms by recall-notice count

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

72 246th of 14151 higher than 13,904 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 · 2026-09-14

Heartware, Inc. in the notice-volume neighbourhood

Distinct federal recall events among this firm and nearest nationwide peers

notices

What this shows Heartware, Inc. holds about 0.069% of archive notices alongside 72 distinct filings.

Source FDA · CPSC · USDA FSIS · NHTSA filings aggregated by PlainRecalls As of September 2026
FDA Devices Critical Jun 3, 2020

Heartware HVAD Pump Outflow Graft, Product (REF) Number 1125
FDA Devices Critical Jun 3, 2020

Heartware HVAD Pump Implant Kit, Product (REF) Number 1104
FDA Devices Critical Jun 3, 2020

Heartware HVAD Pump Implant Kit, Product (REF) Number 1104JP
FDA Devices Critical Jun 3, 2020

Heartware HVAD Pump Implant accessories, Product (REF) Number 1153
FDA Devices Critical Mar 18, 2020

HeartWare HVAD System Battery Charger The HeartWare HVAD System is indicated for hemodynamic support in patients with advanced, refractory left ventricular heart failure; either as a Bridge to Cardiac Transplantation (BTT), myocardial recovery, or as Destination Therapy (DT) in patients for whom subsequent transplantation is not planned.
FDA Devices Critical Mar 18, 2020

HeartWare HVAD System Battery Charger AC Adapter The HeartWare HVAD System is indicated for hemodynamic support in patients with advanced, refractory left ventricular heart failure; either as a Bridge to Cardiac Transplantation (BTT), myocardial recovery, or as Destination Therapy (DT) in patients for whom subsequent transplantation is not planned.
FDA Devices Moderate Dec 19, 2018

Medtronic HeartWare Ventricular Assist HVAD System Battery Charger Model 1600US - Product Usage: The HeartWare Ventricular Assist System (HVAD) is indicated in the United States (US) and European Union (EU) for use as a bridge to cardiac transplantation (BTT) as well as an alternative to transplantation as destination therapy (DT) for patients who are at risk of death from refractory end-stage left ventricular heart failure. The HVAD Pump Controller is a microprocessor unit that controls and man
FDA Devices Moderate Oct 10, 2018

Heart Ware(TM) HVAD(TM) System Controller/Controller Kits, Model Numbers: 1403, 1407, and 1420 Product Usage: The HeartWare HVAD System is indicated for hemodynamic support in patients with advanced, refractory left ventricular heart failure; either as a Bridge to Cardiac Transplantation (BTT), myocardial recovery, or as Destination Therapy (DT) in patients for whom subsequent transplantation is not planned.
FDA Devices Critical Oct 26, 2016

HeartWare Ventricular Assist System Controller Product Usage: 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 HVAD is designed for in-hospital and out-of-hospital settings, including transportation via fix-wing aircraft or helicopter
FDA Devices Critical Oct 19, 2016

HeartWare Ventricular Assist System (HVAD), US product: Model No.: 1103; and International Product: Model No.: 1104XX. Product Usage: For use as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure. Designed for in-hospital and out-of-hospital settings, including transportation via fix-wing aircraft or helicopter.
FDA Devices Critical Jul 20, 2016

HeartWare Ventricular Assist System: HeartWare Battery, Lithium Ion, 14.8 V, Rx only. Catalog 1650 (US) and 1650, 1650-DE and A00035 (OUS) Product Usage: Used 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 is designed for in-hospital and out-of-hospital settings, including transportation via fixed-wing aircraft or helicopter.
FDA Devices Moderate Jul 8, 2015

HeartWare Ventricular Assist System (HVAD) For use as a bridge-to-cardiac transplantation in patient who are at risk of death from refractory end-stage left ventricular heart failure.
FDA Devices Critical Jun 24, 2015

HeartWare Ventricular Assist System (HVAD). Catalog #'s US: 1101 and 1103 / OUS: 1100,1101,1102,1104,1104JP and 1205. For use as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure.
FDA Devices Moderate Jun 17, 2015

HeartWare Ventricular Assist System (HVAD) For use as a bridge-to-cardiac transplantation in patient who are at risk of death from refractory end-stage left ventricular heart failure.
FDA Devices Critical Jun 17, 2015

HeartWare Ventricular Assist System (HVAD). Catalog #: 1101, 1103, 1100, 1101, 1102, 1104, 1104JP, and 1205. Intended for use as a bridge to cardiac transplantation in patients who are at risk of death from refractory end-stage heart failure.
FDA Devices Critical Jun 17, 2015

HeartWare Ventricular Assist System (HVAD). Catalog #'s US: 1101 and 1103 / OUS: 1100, 1101,1102,1104,1104JP and 1205. Product Usage: For use as a bridge-to-cardiac transplantation in patient who are at risk of death from refractory end-stage left ventricular heart failure.
FDA Devices Critical May 20, 2015

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 Mar 4, 2015

HeartWare Ventricular Assist System (HeartWare Controller) Product Usage: 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 System is designed for in-hospital and out-of-hospital settings, including transportation via fix-wing aircraft or helicopter.
FDA Devices Moderate May 21, 2014

HeartWare HVAD Pump Implant Kit (Heartware Ventricular Assist Device) - HeartWare Battery For use as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage ventricular heart failure.The HeartWare VAS is designed for in-hospital and out-of-hospital settings, including transportation via fix-wing aircraft or helicopter.
FDA Devices Critical Apr 30, 2014

Heartware HVAD Pump Implant Kit (Heartware Ventricular Assist Device) Catalog Numbers: 1100, 1101, 1102, 1103, 1104, and 1205. 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 VAS is designed for in-hospital and out-of-hospital settings, including transportation via fix-wing aircraft or helicopter.
FDA Devices Moderate Aug 7, 2013

Heartware HVAD Pump Implant Kit (Heartware Ventricular Assist Device)
FDA Devices Moderate May 22, 2013

Heartware HVAD Pump Implant Kit (Heartware Ventricular Assist Device)

Heartware, Inc. carries an outsized archive share

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 (72 here — heavy-book).

McCain Foods USA 72 Hobbs Medical, Inc. 73 Navilyst Medical, Inc 73 Nephron Sterile Compounding Center LLC 73 Acura,Honda 71

Similar medical devices volume

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

Hobbs Medical, Inc. 73 Navilyst Medical, Inc 73 Karl Storz Endoscopy 71 Zavation 71

Frequently Asked Questions

How many federal recall notices name Heartware, Inc.? ▼
PlainRecalls indexes 72 distinct federal recall events naming Heartware, 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 Heartware, Inc. sit among other recalling firms? ▼
Heartware, Inc. ranks #246 of 14,151 by distinct recall-event count among 14,151 firms in this archive (98th percentile of firms with fewer notices). Rank tracks filing frequency, not product danger.
Which agency issues most of Heartware, Inc.'s notices? ▼
FDA Devices accounts for 72 of this firm's 72 indexed notices.
What product category dominates Heartware, Inc.'s filing book? ▼
Filings for Heartware, 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.
Heartware, Inc.: 72 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, Inc.; individual notices remain authoritative on each linked recall page.

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