FDA Device recall Z-1774-2018

Thoratec HeartMate 3 LVAS Implant Kit, Rx Only, Catalog # 106524US, 106524, 10652INT - LVAS KIT, HM 3 Indicated for providing short-term he…

FDA Device
Class I
terminated
Published 2018-05-23

On 2018-05-23 the FDA classified a Class I recall of Thoratec HeartMate 3 LVAS Implant Kit, Rx Only, Catalog # 106524US, 106524, 10652INT - LVAS KIT, HM 3 Indicated for providing short-term he… by Abbott, citing reports of outflow graft twist occlusions. Patients whose devices experience outflow graft occlusions will experience a persistent low flow alarm. Outflow graft occlusions can res….

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-1774-2018
Classification	Class I
Status	terminated
Initiated	2018-04-05
Published	2018-05-23
Last updated	2026-09-13 11:54 UTC
Company	Abbott
Distribution	AL, AR, AZ, CA, CO, CT, DC, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, NC, NE, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI

Product

Thoratec HeartMate 3 LVAS Implant Kit, Rx Only, Catalog # 106524US, 106524, 10652INT - LVAS KIT, HM 3 Indicated for providing short-term hemodynamic support in patients with advanced refractory left ventricular heart failure.

Reason

Reports of outflow graft twist occlusions. Patients whose devices experience outflow graft occlusions will experience a persistent low flow alarm. Outflow graft occlusions can result in serious adverse events such as hemodynamic compromise, thrombus, and death.

Identifiers

code_info	United States: UDI: 00813024013297, Serial Numbers: MLP 000976, MLP 000989, MLP 000991, MLP 000999, MLP 001002, M… United States: UDI: 00813024013297, Serial Numbers: MLP 000976, MLP 000989, MLP 000991, MLP 000999, MLP 001002, MLP 002020, MLP 002041, MLP 002048, MLP 002049, MLP 002056, MLP 002057, MLP 002058, MLP 002059, MLP 002066, MLP 002069, MLP 002070, MLP 002071, MLP 002072, MLP 002074, MLP 002075, MLP 002076, MLP 002080, MLP 002082, MLP 002084, MLP 002087, MLP 002088, MLP 002090, MLP 002091, MLP 002093, MLP 002096, MLP 002117, MLP 002118, MLP 002119, MLP 002120, MLP 002121, MLP 002123, MLP 002124, MLP 002125, MLP 002126, MLP 002127, MLP 002128, MLP 002130, MLP 002132, MLP 002133, MLP 002134, MLP 002135, MLP 002136, MLP 002137, MLP 002141, MLP 002144, MLP 002152, MLP 002155, MLP 002156, MLP 002157, MLP 002158, MLP 002159, MLP 002160, MLP 002162, MLP 002163, MLP 002161, MLP 002164, MLP 002165, MLP 002188, MLP 002189, MLP 002191, MLP 002192, MLP 002197, MLP 002198, MLP 002200, MLP 002201, MLP 002203, MLP 002204, MLP 002205,

code_info

United States: UDI: 00813024013297, Serial Numbers: MLP 000976, MLP 000989, MLP 000991, MLP 000999, MLP 001002, M…

United States: UDI: 00813024013297, Serial Numbers: MLP 000976, MLP 000989, MLP 000991, MLP 000999, MLP 001002, MLP 002020, MLP 002041, MLP 002048, MLP 002049, MLP 002056, MLP 002057, MLP 002058, MLP 002059, MLP 002066, MLP 002069, MLP 002070, MLP 002071, MLP 002072, MLP 002074, MLP 002075, MLP 002076, MLP 002080, MLP 002082, MLP 002084, MLP 002087, MLP 002088, MLP 002090, MLP 002091, MLP 002093, MLP 002096, MLP 002117, MLP 002118, MLP 002119, MLP 002120, MLP 002121, MLP 002123, MLP 002124, MLP 002125, MLP 002126, MLP 002127, MLP 002128, MLP 002130, MLP 002132, MLP 002133, MLP 002134, MLP 002135, MLP 002136, MLP 002137, MLP 002141, MLP 002144, MLP 002152, MLP 002155, MLP 002156, MLP 002157, MLP 002158, MLP 002159, MLP 002160, MLP 002162, MLP 002163, MLP 002161, MLP 002164, MLP 002165, MLP 002188, MLP 002189, MLP 002191, MLP 002192, MLP 002197, MLP 002198, MLP 002200, MLP 002201, MLP 002203, MLP 002204, MLP 002205,

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1774-2018%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.