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Medtronic Inc Recall 89966

Description: HeartWare HVAD Pump Implant Kit, a) Model Number 1104JP, b) Model Number MCS1705PU

Medtronic Inc Recall 89966 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-1207-2022
Event ID89966
Event DescriptionHeartWare HVAD Pump Implant Kit, a) Model Number 1104JP, b) Model Number MCS1705PU
Product TypeDevices
DistributionWorldwide distribution - US Nationwide DE and TX. There was no military/government distribution. The countries of Germany and Japan.
Quantity21 pump implant kits
Recall ReasonThe pump may have a welding defect that can lead the pump to malfunction. The issue is under investigation by the firm. It is suspected that a weld defect on the center post cap may allow moisture into the center post and corrode the magnets that keep the impeller rotating concentrically, leading to unintended contact between the center post and impeller. If this occurs, it may affect blood flow through the pump. The issue may present clinical signs and symptoms that resemble pump thrombosis.
Device Classification20220615
Device Code Infoa) Model Number 1104JP: GTIN: 00763000170967 Serial numbers: HW41784, HW41825, HW41829, HW41849, HW41852, HW41853, HW41863, HW42312, HW42352, HW42775, HW42818, HW42879, HW42882, and HW42884. b) Model Number MCS1705PU: GTIN 00888707005364, Serial Numbers: HW42448 and HW42571; GTIN 00888707007139, Serial Numbers: HW42955 and HW42962; GTIN 00888707009041, Serial Numbers HW43483 and HW43484; and GTIN 00888707003070, Serial number HW42153.
Center Classification Date20220603
Recall Initiation Date20220414
Recalling FirmMedtronic Inc
Initial Notification Letter
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