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Thoratec HeartMate 3 recallZ-2348-2019 · Thoratec Corp. · initiated Mar 30, 2019

Terminated

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 Thoratec Corp. 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

Outflow Graft leaking at the pump connection during the implantation process. If the C-Ring is insufficiently seated, it renders the device nonfunctional because the Outflow Graft connection will leak during the implant procedure.

FDA root cause category: Process design

What the company is doing

On March 30, 2019 all consignees were hand delivered the "Urgent Medical Device Recall" letter. The recall letter stated the following: 1. Abbott is recalling 208 HeartMate 3 Outflow Graft units globally (87 within the US). An Abbott Representative will be contacting you within the coming weeks to identify the specific units that are impacted in your inventory and replace them. 2. In the interim, continued implants with the current HeartMate 3 Outflow Grafts can still be conducted with standard implant procedures by following the HeartMate 3 Instructions for Use. However, in addition to following the existing instruction of checking for blood leaks and bleeding at the Outflow Graft When the flow through the blood pump is satisfactory, we now recommend that adequate performance of the Screw Ring attachment to the pump be evaluated before the device is brought to the surgical field. If the Screw Ring does not function properly, the Outflow Graft should be replaced with a backup Outflow Graft. Patient Management Recommendations 3. For patients implanted with the HeartMate 3 Left Ventricular Assist System (LVAS), Abbott confirms there is no risk due to this issue. Patients should be managed per standard clinical practice. 4. Please complete the acknowledgement form included in this packet and return to Abbott. If you are a consignee of this letter within your organization, please notify all users of the device within your organization. 5. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDAs MedWatch Adverse Event Reporting program either online, by regular mail, or by fax. " Complete and submit the report Online: www.fda.gov/medwatch/report.htm " Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed from, or submit by fax to 1-800-FDA-0178. 6. If you have questions,

Recall details

Recall number
Z-2348-2019
Status
Terminated
Initiated by the company
Mar 30, 2019
Recalling firm
Thoratec Corp.
Quantity
7200 left ventricular assist systems
Product code
DSQ
FDA submissions
P160054
Distribution
Worldwide distribution. US nationwide, Australia, Austria, Brazil, Canada, Cayman Islands, Chile, Colombia, Egypt, France, Germany, Greece, Singapore, Iran, Italy, Kuwait, Lebanon, Romania, Switzerland, Thailand, United Kingdom.

Product description

Thoratec HeartMate 3 LVAS Implant Kit, Sterile, REF 106524/106524US, RX only, Left Ventricular Assist System

Code information (models, lots, serial numbers)

106524/106524US: The shelf life is 36 months from date of manufacture. All batch/lot numbers 6613000 or 50000000 or higher.   UDI/GMDN 00813024013297 / 47533

Devices named in this recall

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

Product lines

Other devices under the same FDA submission

25 devices cleared under P160054 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 83357).

Sources and updates

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