Z-1207-2022Class I

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

Name: Z-1207-2022 HeartWare HVAD Pump Implant Kit, a) Model Number 1104JP, b) Model Number MCS1705PU
Creator: Medtronic Inc
Published: 2022-04-14
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2022-04-14 / Open, Classified / root cause: manufacturing process

FDA source

Medtronic Inc began a recall of HeartWare HVAD Pump Implant Kit, a) Model Number 1104JP, b) Model Number MCS1705PU on 2022-04-14. FDA classified it as Class I and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1207-2022
Classification: Class I
Status: Open, Classified
Initiated: 2022-04-14
Posted: 2022-06-03
Recalling firm: Medtronic, Inc.
Product: HeartWare HVAD Pump Implant Kit, a) Model Number 1104JP, b) Model Number MCS1705PU
Product code: DSQ Ventricular (Assist) Bypass
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.
Root cause tag: manufacturing process
FDA root cause: Under Investigation by firm
Action: The firm issued letters flagged "Urgent Medical Device Recall" dated April 2022 on 4/14/2022 via 2-day UPS delivery. The letter provided the issue description and requested the consignee to take the following actions: Immediately quarantine and return the unused affected product, complete the enclosed Customer Confirmation Form and email it to the firm, share the notice with all those who need to be aware within their organization or to any organization where the existing product has been transferred, and retain the notification for their records regarding the retrieval of the unused affected product. The Customer Confirmation Form confirms the consignee has read the letter and taken appropriate action. The consignee is to indicate the product and serial number that is being returned. The consignee is also supposed to list the product and serial number of the HVAD Pump implant kits that have been implanted. Return instructions are also provided. Beginning April 26, 2022, the firm send a follow-up communication to all VAD centers with patients on support to communicate that this retrieval has been conducted as well as informing them of the ongoing investigation and providing patient management recommendations.
Quantity in commerce: 21 pump implant kits
Distribution: Worldwide distribution - US Nationwide DE and TX. There was no military/government distribution. The countries of Germany and Japan.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1207-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1207-2022	Class I	Ongoing	Voluntary: Firm initiated	2022-06-15	2022-06-03

Product code DSQ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)