The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0478-2024·Announced 2023-12-13

Medical Device Instruction Update: HVAD Ventricular Assist Device Clarifications

HeartWare is issuing clarifications to instructions for the PUMP 1103 HVAD ventricular assist device regarding when Controller Fault alarms sound and component useful life. No illnesses or injuries have been reported.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall of a life-critical implantable ventricular assist device. Although no illnesses or injuries have been reported, the issue involves instruction clarity on alarm conditions and component lifespan for a device upon which implant recipients depend for survival, presenting a risk-of-harm scenario. The recall addresses this through instructional updates rather than device replacement.

Plain-English summary

HeartWare, Inc. is recalling the PUMP 1103 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT, Model Number 1103, with an estimated 7,438 units distributed worldwide. The recall involves issuing updated instructions for use (IFU) and a patient manual to clarify two critical areas: the conditions under which the HVAD Controller Fault alarm may sound and the recommended troubleshooting actions when this alarm occurs.

Additionally, the updates will provide clarified instructions regarding the useful life of HVAD system components. A ventricular assist device is an implantable pump that helps maintain blood circulation for patients with severe heart failure. Unclear instructions about alarm conditions and component lifespan could lead patients and clinicians to misunderstand when intervention or component replacement is necessary, potentially affecting device performance and patient safety.

Patients who have received the PUMP 1103 HVAD implant and their healthcare providers should review the updated instructions and patient manual when received from HeartWare, Inc. No illnesses or injuries have been reported in connection with this recall to date. Patients with questions about the updated instructions should contact their implanting physician or HeartWare, Inc. directly.

The recalled product

Product
PUMP 1103 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT, Model Number 1103
Manufacturer
Heartware, Inc.
Category
Medical Device — Implantable Cardiovascular Device
Hazard
Affected units
7,438

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • GTIN none
  • Serial Numbers: HW10991
  • HW11011
  • HW11012
  • HW11013
  • HW11017
  • HW11019
  • HW11020
  • HW11022
  • HW11023
  • HW11024
  • HW11026
  • HW11030
  • HW11032
  • HW11033
  • HW11034
  • HW11035
  • HW11036
  • HW11037
  • HW11038

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 9 recalled by Heartware, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 9 products in this recall →

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