Thoratec HeartMate 3 LVAS Implant Kit — Class I medical device recall Z-1774-2018
Terminated recall by Abbott, reported 2018-05-23, distributed in AL, AR, AZ, CA, CO, CT, DC, FL…. Reports of outflow graft twist occlusions. Patients whose devices experience outflow graft occlusions will exp
| Recall number | Z-1774-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Abbott, Pleasanton, CA, United States |
| Recall initiated | 2018-04-05 |
| Classified | 2018-05-16 |
| Reported by FDA | 2018-05-23 |
| Terminated | 2021-10-15 |
| Distributed | 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 |
| Countries outside the US | AE, AT, AU, BE, BR, CA, CH, CO, CZ, DE, DK, EG, ES, FR, GB, GR, HK, HR, HU, IN, IT, KW, KY, LB, MY, NL, PL, QA, RO, RS, SA, SE, SG, SI, SK |
| Quantity | 5,607 |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 00813024013297 |
| Serial numbers | 000976, 000989, 000991, 000999, 001002, 002020, 002041, 002048, 002049, 002056, 002057, 002058, 002059, 002066, 002069, 002070, 002071, 002072, 002074, 002075, 002076, 002080, 002082, 002084, 002087 and 475 more |
| Model numbers | 106524, 106524US, 10652INT |
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 for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1774-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.