The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0743-2023·Announced 2022-12-28

HeartWare Model 1101 Implant: Hardened Driveline Cover May Delay Connector Access

The driveline cover on some HeartWare Model 1101 implanted pumps may harden over time, making it difficult to access the driveline connector. This could delay urgent maintenance, potentially causing 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: This is a Class II medical device recall for an implantable cardiac pump where a component may harden, delaying access to critical connectors needed for urgent maintenance. No illnesses or injuries have been reported, but the potential consequence of delayed pump access—prolonged pump stoppage causing patient harm—qualifies this as a risk-of-harm product where injury has not yet been reported.

Plain-English summary

HeartWare, Inc. is recalling the HeartWare Model 1101 implantable left ventricular assist device. The FDA has identified that the driveline cover on affected units may become hardened over time.

As the driveline cover hardens, it becomes difficult or impossible to slide back to access the driveline to controller connector. When urgent maintenance or troubleshooting is needed, delayed access to this connector may result in prolonged pump stoppage and patient harm.

The recall affects 82 units with specific serial numbers distributed worldwide. If you are using a HeartWare Model 1101 and observe a hardened driveline cover, contact your Medtronic field representative for further assessment and servicing.

The recalled product

Product
HeartWare Model 1101
Manufacturer
Heartware, Inc.
Category
Medical Device — Implantable Cardiac Pump
Hazard
Affected units
82

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: HW1146
  • HW1205
  • HW1209
  • HW1247
  • HW1454
  • HW1533
  • HW1634
  • HW1688
  • HW1951
  • HW200
  • HW281
  • HW378
  • HW383
  • HW469
  • HW492
  • HW557
  • HW816
  • HW933
  • HW1091
  • HW1143

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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