HeartWare HVAD Pump Implant Kit, a) Model Number 1104JP, b) Model Number MCS1705PU
Summary
The FDA issued a Class I for HeartWare HVAD Pump Implant Kit, a) Model Number 1104JP, b) Model Number MCS1705 by Medtronic Inc. Reason: 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 de.
Details
Source
Device Recall
External ID
Z-1207-2022
Action Date
2022-06-15
Status
Ongoing
Category
device
Product Description
HeartWare HVAD Pump Implant Kit, a) Model Number 1104JP, b) Model Number MCS1705PU
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.
Quantity Affected: 21 pump implant kits
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-04-14
Company
Minneapolis, MN
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 178 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Medtronic Inc has 83 FDA actions in our database, including 46 recalls and 37 clearances.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Medtronic Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Medtronic Inc have FDA actions?
Medtronic Inc has 83 FDA actions in our database, including 46 recalls and 37 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1207-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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