FDA-Device2021-02-10Class I
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
Heartware, Inc.
Hazard
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.
Sold states
Worldwide - US Nationwide
Affected count
19,562 units
Manufactured in
14400 Nw 60th Ave, Miami Lakes, FL, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0946-2021Don't want to check this manually?
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