Lower riskMedical device recall · FDA · Published February 26, 2021
Heartware HVAD System Instructions Update: Clarify Carrying Cases and Driveline Safety
Heartware recalls updated instructions for use and patient manuals for HVAD System components to address carrying case orientation, driveline cover safety, and power-up sequence clarity. These updates prevent potential misuse of the critical heart failure support device.
Medtronic HeartWare HVAD System Instructions for Use (IFU) and Patient Manual (PM) updates regarding: Carrying Cases, Driveline Cover Orientation, and Controller Power Up Sequence issues. The PM is being updated to clarify use of the support strap and wear instructions in addition to cleaning instructions of the carrying cases. The IFU and PM are being updated to add a useful life for the carrying cases. The PM is being updated to inform users to keep the driveline cover on when disconnecting and reconnecting the driveline. The IFU and PM are being updated to clarify the power-up sequence that causes the alarm indicator LEDs and both sets of battery LEDs to turn red for 2.5 seconds while the LCD displays the power-on message. NOTE: this update is included in the February 2021 Urgent Medical Device Notice also covered in recalls 87603 and 87604
Heartware is recalling updated instructions for use and patient manuals for their HVAD heart failure support system. These updates clarify how to safely handle carrying cases, properly orient the driveline cover, and follow the correct power-up sequence to avoid potential misuse of this critical medical device. Read more at govinfonow.com/recall/63212-heartware-hvad-system-instructions-update-clarify-carrying-cases-and-driveline.
“Heartware HVAD System Instructions Update: Clarify Carrying Cases and Driveline Safety.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63212-heartware-hvad-system-instructions-update-clarify-carrying-cases-and-driveline. Based on FDA recall #Z-1426-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1426-2021%22&limit=1).
The FDA announced on Feb. 26, 2021, that Heartware, Inc. is recalling Instructions for Use and Patient Manuals for the HeartWare HVAD System due to updates regarding carrying cases, driveline cover orientation, and controller power-up sequences. The agency issued recall number Z-1426-2021 for the Class I voluntary recall.
How to tell if you have it
Brand: Heartware
Product: Instructions for Use and Patient Manual for HeartWare HVAD System
Accompanying components include HVAD Sterile Implant Kit (Models 1100, 1101, 1102, 1103, 1104, 1104JP, 1205), HVAD Controller Kit (Models 1403US, 1407AU, 1407CA, 1407CH, 1407DE, 1407GB, 1407IL, 1407IN, 1407IT, 1407JP, 1407KR, 1420, 1420JP), HVAD AC Adapter Controller (Models 1430AR, 1430AU, 1430CA, 1430CH, 1430DE, 1430GB, 1430IL, 1430IN, 1430IT, 1430JP, 1430US), HVAD DC Adapter Controller (Model 1440), HVAD DATA CABLE 1575-MONITOR (Model 1575), HVAD Battery Pack (Models 1650, 1650CA-CLIN, 1650DE), HeartWare Patient Pack (Model 1475), HeartWare Waist Pack (Models 2050, 2050IL, 2050OUS), and HeartWare Shoulder Pack (Models 2060, 2060IL, 2060OUS)
Quantity: 23123 devices worldwide (11292 in the US)
The hazard
The recall addresses updates to the Instructions for Use and Patient Manual concerning carrying cases, driveline cover orientation, and controller power-up sequence issues. The updates clarify the use of the support strap, wear instructions, cleaning of carrying cases, useful life for cases, keeping the driveline cover on during connection, and clarifying the power-up sequence that triggers specific LED alarms.
Context
GovInfoNow's records show Heartware, Inc. has had 17 other recalls since Aug. 28, 2018. On Oct. 31, 2023, the company recalled a Sterile Implant Kit to clarify controller faults in system instructions. A May 16, 2023 recall addressed logfiles from Model 1521 monitors that were not processable by the Autologs Portal. Another recall on Nov. 29, 2022 involved a Model 1102 driveline cover hardening that may delay pump access.
How to tell if you have this one
Check if you own the Heartware HVAD System components with model numbers listed in the recall notice, including the HVAD Sterile Implant Kit (models 1100-1104, 1205, MCS1705PU), HVAD Controller Kit (models 1403US-1420), and other specified components. The recall applies to all units with the listed model numbers and serial numbers.
Brand
Heartware
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Review Updated Instructions
Check the updated Instructions for Use and Patient Manual for Heartware HVAD System components to ensure you have the latest version addressing carrying cases, driveline cover orientation, and power-up sequence.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Worldwide distribution: US (nationwide) and countries of: ARGENTINA, Armenia, Australia, AUSTRIA, Bahrain, BELGIUM, Brazil, CANADA, Chile, Colombia, Croatia, Czech Republic, Denmark, Egypt, Estonia, FINLAND, France, GERMANY, Greece, Hong…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 2 months after the firm started it.
1Firm started the recall
2FDA classified it Class I
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1426-2021 (February 26, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1426-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.