Heartware, Inc.: Medical Device Recall in 2021 - (Recall #: Z-1337-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

Power Supply: 1. Medtronic HVAD Controller AC Adapter, Product Numbers: 1425AU, 1425CA, 1425DE, 1425GB, 1425IL, 1425IT, 1425US, 1430AR, 1430AU, 1430CA, 1430CH, 1430DE, 1430GB, 1430IL, 1430IN, 1430IT, 1430JP, 1430US 2. Medtronic HVAD Controller DC Adapter, Product Number: 1440

Product Classification:

Class I

Date Initiated: February 26, 2021

Date Posted: April 14, 2021

Recall Number: Z-1337-2021

Event ID: 87446

Reason for Recall:

There is the potential for the Controller power cables (AC Adapter, DC Adapter, and Battery cables), HVAD Alarm Adapter, and HVAD Monitor data cables to cause damage to the HVAD Controller ports when inserting the cables into the Controller ports, due to wear from misalignment of the cables to the port.

Status: Ongoing

Product Quantity: 17992 units (8054 US)

Code Information:

All lot codes

Distribution Pattern:

Worldwide

Voluntary or Mandated:

Voluntary: Firm initiated