FDA Device recall Z-0946-2021

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. Mo…

FDA Device
Class I
ongoing
Published 2021-02-10

On 2021-02-10 the FDA classified a Class I recall of 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. Mo… by Heartware, citing 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 numbe….

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-0946-2021
Classification	Class I
Status	ongoing
Initiated	2020-11-19
Published	2021-02-10
Last updated	2026-09-13 11:56 UTC
Company	Heartware
Distribution	US

Product

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

Reason

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.

Identifiers

code_info	a. Model Number 1103: GTIN 00888707003261, Serial Numbers HW40002, HW40004, HW40006, HW40009, HW40017, HW40025, HW4004… a. Model Number 1103: GTIN 00888707003261, Serial Numbers HW40002, HW40004, HW40006, HW40009, HW40017, HW40025, HW40045, HW40046, HW40048, HW40049, HW40051, HW40054, HW40061, HW40067, HW40068, HW40073, HW40074, HW40075, HW40079, HW40085, HW40087, HW40089, HW40090, HW40094, HW40097, HW40099, HW40100, HW40109, HW40112, HW40120, HW40121, HW40122, HW40138, HW40139, HW40143, HW40145, HW40147, HW40149, HW40152, HW40153, HW40154, HW40157, HW40166, HW40168, HW40169, HW40176, HW40177, HW40178, HW40186, HW40189, HW40190, HW40192, HW40197, HW40199, HW40200, HW40201, HW40202, HW40206, HW40209, HW40210, HW40211, HW40212, HW40223, HW40226, HW40230, HW40232, HW40238, HW40240, HW40245, HW40247, HW40259, HW40262, HW40263, HW40270, HW40271, HW40272, HW40273, HW40281, HW40283, HW40288, HW40292, HW40293, HW40294, HW40295, HW40298, HW40299, HW40301, HW40302, HW40303, HW40305, HW40307, HW40317, HW40322, HW40324, HW40326, HW40329, HW40334, HW40337, HW40340, HW40359, HW40371, HW40373, HW40376, HW40381, HW403

code_info

a. Model Number 1103: GTIN 00888707003261, Serial Numbers HW40002, HW40004, HW40006, HW40009, HW40017, HW40025, HW4004…

a. Model Number 1103: GTIN 00888707003261, Serial Numbers HW40002, HW40004, HW40006, HW40009, HW40017, HW40025, HW40045, HW40046, HW40048, HW40049, HW40051, HW40054, HW40061, HW40067, HW40068, HW40073, HW40074, HW40075, HW40079, HW40085, HW40087, HW40089, HW40090, HW40094, HW40097, HW40099, HW40100, HW40109, HW40112, HW40120, HW40121, HW40122, HW40138, HW40139, HW40143, HW40145, HW40147, HW40149, HW40152, HW40153, HW40154, HW40157, HW40166, HW40168, HW40169, HW40176, HW40177, HW40178, HW40186, HW40189, HW40190, HW40192, HW40197, HW40199, HW40200, HW40201, HW40202, HW40206, HW40209, HW40210, HW40211, HW40212, HW40223, HW40226, HW40230, HW40232, HW40238, HW40240, HW40245, HW40247, HW40259, HW40262, HW40263, HW40270, HW40271, HW40272, HW40273, HW40281, HW40283, HW40288, HW40292, HW40293, HW40294, HW40295, HW40298, HW40299, HW40301, HW40302, HW40303, HW40305, HW40307, HW40317, HW40322, HW40324, HW40326, HW40329, HW40334, HW40337, HW40340, HW40359, HW40371, HW40373, HW40376, HW40381, HW403

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0946-2021%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.