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HVAD Pump Implant Kit recallZ-1207-2022 · Medtronic Inc · initiated Apr 14, 2022

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Medtronic Inc or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Under Investigation by firm

What the company is doing

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.

Recall details

Recall number
Z-1207-2022
Status
Open, Classified
Initiated by the company
Apr 14, 2022
Recalling firm
Medtronic Inc
Quantity
21 pump implant kits
Product code
DSQ
FDA submissions
P100047
Distribution
Worldwide distribution - US Nationwide DE and TX. There was no military/government distribution. The countries of Germany and Japan.

Product description

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

Code information (models, lots, serial numbers)

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.

Devices named in this recall

2 devices in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

31 devices cleared under P100047 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Sources and updates

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