HeartWare HVAD Pump Implant Kit, a) Model Number 1104JP, b) Model Number MCS1705PU
Check against the official notice below — it lists the full affected range.
Medtronic Inc. is recalling 21 HeartWare HVAD Pump Implant Kits (Model Numbers 1104JP and MCS1705PU) due to a suspected welding defect on the center post cap. The defect may allow moisture to enter the center post and corrode the magnets responsible for keeping the impeller rotating properly, potentially causing unintended contact between the center post and impeller that could affect blood flow through the pump. The issue is under investigation and may present symptoms similar to pump thrombosis.
The affected pump kits were distributed worldwide, including to the United States (nationwide, Delaware, and Texas), Germany, and Japan. The specific affected units are identified by model number and serial number, with 14 units of Model 1104JP and 7 units of Model MCS1705PU involved in the recall. The source does not specify what action affected consumers should take.
Written by software from the official notice below. Not reviewed by a lawyer.
The 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.
Reason for recall: The 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. Distribution: Worldwide distribution - US Nationwide DE and TX. There was no military/government distribution. The countries of Germany and Japan. Quantity: 21 pump implant kits Lot/code info: a) 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.
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.