The Recall Desk
HighFDA (Devices)·Z-2478-2021·Announced 2021-09-22

Medtronic HVAD Pump Implants: Driveline Cover May Impede Connector Access

Medtronic HVAD Pump Implant Kits may require increased force to remove the driveline cover after strain relief repair, potentially making controller exchanges difficult and risking further repair damage.

What this means for you

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 an implanted cardiac support device with a functional issue affecting serviceability and repair integrity. No injuries or illnesses have been reported, but the issue presents a risk of harm during necessary clinical procedures, meeting the rubric criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Medtronic HVAD Pump Implant Kits are being recalled due to an issue affecting the driveline cover (boot cover) assembly after strain relief repair procedures.

The problem occurs after a Driveline Strain Relief Repair is completed. The repair increases the force needed to slide the driveline cover away from the connector. This increased resistance may make it difficult to pull back the driveline cover when accessing the driveline connector during a controller exchange. Additionally, sliding the driveline cover over a strain relief repair may cause damage to the repair itself.

The affected products are Model Numbers 1100, 1101, 1102, 1103, 1104, 1104JP, 1205, and MCS1705PU across all serial numbers. These devices have been distributed throughout the United States and internationally.

Patients with these implanted devices should contact their cardiologist or Medtronic if they require a controller exchange or if they have questions about their device. Clinicians should be aware of this issue when planning any procedures that require access to the driveline connector.

The recalled product

Product
Medtronic HVAD Pump Implant Kits
Manufacturer
Heartware, Inc.
Category
Medical Device — Cardiac Support Device
Hazard
  • connector-access-difficulty
  • repair-compromise

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 (8)

  • Product Numbers: 1100
  • 1101
  • 1102
  • 1103
  • 1104
  • 1104JP
  • 1205
  • and MCS1705PU - all serial numbers

Distribution

Distribution scope not specified by the agency.

Related recalls

Same category