Heartware, Inc. recalls Medtronic HVAD Pump Implant Kits, labeled as: a. PUMP 1103, b. PUMP 1104, c. PUMP 1104JP, d. PUMP 1100, e. Model 1101,…

Recall date

November 19, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0946-2021

FDA classification

Class I

Brand / firm

Heartware, Inc.

Sold / distributed

Worldwide - US Nationwide

Why it was recalled

Pumps manufactured with impellers from a subset of lots from a single supplier are failing to initially start, restart, or experiencing a delay in restart within the maximum number of restart attempts at a rate substantially higher than pump in the overall population.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

Medtronic HVAD Pump Implant Kits, labeled as: a. PUMP 1103, b. PUMP 1104, c. PUMP 1104JP, d. PUMP 1100, e. Model 1101, f. Model 1102, g. Model 1104CA-CLIN, h. Model 1205, i. Model MCS1705PU