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 Moderate Dec 13, 2023

PUMP 1103 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT, Model Number 1103
FDA Devices Moderate Dec 13, 2023

HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT/IMPLANT KIT OUS, Model Number 1205
FDA Devices Moderate Dec 13, 2023

PUMP 1104 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT EN JA, Model Number 1104JP
FDA Devices Moderate Dec 13, 2023

HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT, Model Number 1100
FDA Devices Moderate Dec 13, 2023

PUMP 1104 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT, Model Number 1104
FDA Devices Moderate Dec 13, 2023

PUMP MCS1705PU HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT US, Model Number MCS1705PU
FDA Devices Moderate Dec 13, 2023

STERILE HVAD (HeartWare Ventricular Assist Device) PUMP (US), Model Number 1101
FDA Devices Moderate Dec 13, 2023

HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT, Model Number 1102
FDA Devices Moderate Dec 13, 2023

1104CA-CLIN - HVAD (HeartWare Ventricular Assist Device) PUMP, Model Number 1104CA-CLIN
FDA Devices Moderate Jun 28, 2023

HeartWare Ventricular Assist Device System. a) Monitor 1521US Explore Tech, b) Monitor 1521GB Explore Tech, c) Monitor 1521IL Explore Tech, d) Monitor 1521DE Explore Tech
FDA Devices Moderate Dec 28, 2022

HeartWare Model 1100
FDA Devices Moderate Dec 28, 2022

HeartWare HVAD Pump Kit, REF 1104CA-CLIN
FDA Devices Moderate Dec 28, 2022

HeartWare Model 1101
FDA Devices Moderate Dec 28, 2022

HeartWare HVAD Pump Kit, REF 1103
FDA Devices Moderate Dec 28, 2022

HeartWare HVAD Pump Kit, REF 1104
FDA Devices Moderate Dec 28, 2022

HeartWare HVAD Pump Kit, REF MCS1705PU
FDA Devices Moderate Dec 28, 2022

HeartWare Model 1102
FDA Devices Moderate Dec 28, 2022

HeartWare HVAD Pump Kit, REF 1205
FDA Devices Moderate Dec 28, 2022

HeartWare HVAD Pump Kit, REF 1104JP
FDA Devices Critical Aug 24, 2022

HeartWare Ventricular Assist Device (HVAD) System Batteries, Product Number 1650DE
FDA Devices Moderate May 25, 2022

HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1407DE Kit
FDA Devices Moderate May 25, 2022

HeartWare Ventricular Assist Device (HVAD) System, Model Number 1521DE, MONITOR 1521DE EXPLORE TECH
FDA Devices Moderate May 25, 2022

HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1420
FDA Devices Moderate May 25, 2022

HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1420-Controller 2.0
FDA Devices Moderate May 25, 2022

HeartWare Ventricular Assist Device (HVAD) System, individual pamphlets: HVAD¿ System Emergency Responder Guide (FI-Finnish) HVAD¿ System Emergency Responder Guide (FI-Finnish) HVAD¿ System Emergency Responder Guide (FI-Finnish) HVAD¿ System Emergency Responder Guide (FI-Finnish) HVAD¿ System Instructions For Use (FI) HVAD¿ System Instructions For Use (FI) HVAD¿ System Patient Manual (FI-Finnish) HVAD¿ System Patient Manual (FI-Finnish) HVAD¿ System Patient Manual (FI-Finnish) HVAD¿ S
FDA Devices Moderate May 25, 2022

HeartWare Ventricular Assist Device (HVAD) System, Pump Implant Kit, Model Number1104
FDA Devices Moderate Mar 16, 2022

HeartWare Ventricular Assist Device (HVAD) System
FDA Devices Moderate Sep 22, 2021

Medtronic HVAD Pump Implant Kits
FDA Devices Critical Aug 18, 2021

HeartWare HVAD Pump Implant Kit, REF 1125
FDA Devices Critical Aug 18, 2021

HeartWare HVAD Pump Implant Kit, REF 1153
FDA Devices Critical Aug 18, 2021

HeartWare HVAD Outflow Graft, REF MCS1725OG
FDA Devices Critical Aug 18, 2021

HeartWare HVAD Pump Accessories, REF MCS1753AK
FDA Devices Critical Aug 18, 2021

HeartWare HVAD Driveline Extension Cable, REF 100
FDA Devices Critical Aug 18, 2021

HeartWare HVAD Pump Implant Kit, REF 1103
FDA Devices Critical Aug 18, 2021

HeartWare HVAD Pump Implant Kit, REF 1104
FDA Devices Critical Aug 18, 2021

HeartWare HVAD Implant Kit, REF 1104JP
FDA Devices Critical Aug 18, 2021

HeartWare HVAD Driveline Extension Cable, REF 100US
FDA Devices Critical Aug 18, 2021

HeartWare HVAD Implant Kit, REF MCS1705PU
FDA Devices Moderate Jul 21, 2021

HeartWare, HVAD Pump Implant Kit, REF MCS1705PU - Product Usage: 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 Apr 28, 2021

Instructions for Use and Patient Manual for HeartWare HVAD System. Accompanies these devices: Heartware HVAD pump implant kits Models 1100, 1101, 1102, 1103, 1104, 1104JP, 1205, and MCS1705PU. Heartware HVAD controller kits Models 1403US, 1407AU, 1407CA, 1407CH, 1407DE, 1407GB, 1407IL, 1407IN, 1407IT, 1407JP, 1407KR, 1420, and 1420JP. Heartware HVAD controller AC adapter Models 1430AR, 1430AU, 1430CA, 1430CH, 1430DE, 1430GB, 1430IL, 1430IN, 1430IT, 1430JP, and 1430US. Heartware
FDA Devices Moderate Apr 28, 2021

Instructions for Use and Patient Manual for HeartWare HVAD System. Accompanies these devices: Heartware HVAD pump implant kits Models 1100, 1101, 1102, 1103, 1104, 1104JP, 1205, and MCS1705PU. Heartware HVAD controller kits Models 1403US, 1407AU, 1407CA, 1407CH, 1407DE, 1407GB, 1407IL, 1407IN, 1407IT, 1407JP, 1407KR, 1420, and 1420JP. Heartware HVAD controller AC adapter Models 1430AR, 1430AU, 1430CA, 1430CH, 1430DE, 1430GB, 1430IL, 1430IN, 1430IT, 1430JP, and 1430US. Heartware HVAD co
FDA Devices Critical Apr 28, 2021

Instructions for Use and Patient Manual for HeartWare HVAD System. Accompanies these system components: HVAD Sterile Implant Kit, Model Numbers: 1100, 1101, 1102, 1103, 1104, 1104JP, 1205, MCS1705PU HVAD Controller Kit, Model Numbers: 1403US, 1407AU, 1407CA, 1407CH, 1407DE, 1407GB, 1407IL, 1407IN, 1407IT, 1407JP, 1407KR, 1420, 1420JP HVAD AC Adapter Controller, Model Numbers: 1430AR, 1430AU, 1430CA, 1430CH, 1430DE, 1430GB, 1430IL, 1430IN, 1430IT, 1430JP, 1430US HVAD DC Adapter Controller: M
FDA Devices Critical Apr 14, 2021

Medtronic HVAD Controller, Product Numbers: 1400, 1401, 1401AU, 1401BR, 1401CA, 1401CH, 1401DE, 1401GB, 1401IL, 1401IN, 1401IT, 1401JP, 1401US, 1403US, 1407AR, 1407AU, 1407BR, 1407CA, 1407CA-CLIN, 1407CH, 1407DE, 1407GB, 1407IL, 1407IN, 1407IT, 1407JP, 1407KR
FDA Devices Critical Apr 14, 2021

Medtronic HVAD Battery, Product Number: 1650, 1650CA-CLIN, 1650DE
FDA Devices Critical Apr 14, 2021

Medtronic HVAD Monitor Data Cable, Product Number: 1575
FDA Devices Critical Apr 14, 2021

Power Supply: 1. Medtronic HVAD Controller AC Adapter, Product Numbers: 1425AU, 1425CA, 1425DE, 1425GB, 1425IL, 1425IT, 1425US, 1430AR, 1430AU, 1430CA, 1430CH, 1430DE, 1430GB, 1430IL, 1430IN, 1430IT, 1430JP, 1430US 2. Medtronic HVAD Controller DC Adapter, Product Number: 1440
FDA Devices Critical Apr 14, 2021

Medtronic HVAD Alarm Adapter, Product Number: 1450
FDA Devices Critical Apr 14, 2021

Medtronic HVAD Packaged Monitor, Model Numbers: 1500, 1500AU, 1500DE, 1510US, 1511AR, 1511AU, 1511BR, 1511CA, 1511CH, 1511DE, 1511GB, 1511IL, 1511IN, 1511IT, 1511JP, 1511MY, 1520CLIN-AU, 1520CLIN-DE, 1520CLIN-GB, 1520JP, 1520US, 1521AU, 1521BR, 1521CA, 1521CH, 1521DE, 1521GB, 1521IL, 1521IN, 1521IT, 1521JP, 1521KR, 1521TW, 1521US, 1522CA, 1522CA-CLIN
FDA Devices Critical Feb 10, 2021

Medtronic HVAD Pump Implant Kits, labeled as: a. PUMP 1103, b. PUMP 1104, c. PUMP 1104JP, d. PUMP 1100, e. Model 1101, f. Model 1102, g. Model 1104CA-CLIN, h. Model 1205, i. Model MCS1705PU
FDA Devices Critical Jun 3, 2020

Heartware HVAD Pump Implant Kit, Product (REF) Number 1103

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