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

Recall Insight

This FDA Devices action (record #Z-1207-2022) was formally reported on June 15, 2022, with the manufacturer initiating the action on April 14, 2022. It is classified under Critical severity (Class I), with a current status of Ongoing. Medtronic Inc is listed as the recalling firm, operating out of Minneapolis, MN. Federal records indicate 21 pump implant kits units are affected.

The documented reason for this recall is: 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 a… Distribution data in the federal record shows the product reached: Worldwide distribution - US Nationwide DE and TX. There was no military/government distribution. The countries of Germany and Japan.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 4 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.