The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0742-2023·Announced 2022-12-28

HeartWare Model 1100 driveline cover hardening may delay urgent access

HeartWare Model 1100 driveline covers may harden over time, making it difficult or impossible to access the driveline-to-controller connector. A delay in accessing the connector during an urgent issue could result in prolonged pump stoppage and patient harm.

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: FDA Class II recall of a risk-of-harm product (critical implantable device) where injury has not yet been reported. The hazard could delay emergency access needed to prevent patient harm, but no actual illnesses or injuries are documented.

Plain-English summary

HeartWare, Inc. is recalling 45 units of the HeartWare Model 1100, an implantable ventricular assist device, due to a driveline cover defect.

Over time, the driveline cover may become hardened, creating difficulty or inability to slide the cover back to access the driveline-to-controller connector. When the cover hardens, accessing the connector may be delayed. A delay in accessing the connector when an urgent driveline connection or controller issue needs to be addressed may result in patient harm from a prolonged pump stop.

The affected devices have been distributed worldwide. Patients and healthcare providers should contact their Medtronic field representative for assessment and servicing if a hardened driveline cover is observed on an affected device. Unless otherwise advised by healthcare providers, continue normal use of the device.

The recalled product

Product
HeartWare Model 1100
Manufacturer
Heartware, Inc.
Category
Medical Device — Implantable Ventricular Assist Device
Hazard
Affected units
45

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)

  • Serial Numbers: HW001
  • HW012
  • HW016
  • HW017
  • HW023
  • HW025
  • HW028
  • HW044
  • HW045
  • HW046
  • HW047
  • HW049
  • HW050
  • HW051
  • HW061
  • HW064
  • HW083
  • HW084
  • HW086
  • HW091

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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