Z-2349-2019Class II

Thoratec Heartmate 3 Sealed Outflow Graft with Bend Relief, Sterile, REF 105581US/105581, RX only, Part of...

Name: Z-2349-2019 Thoratec Heartmate 3 Sealed Outflow Graft with Bend Relief, Sterile, REF 105581US/105581, RX only, Part of...
Creator: Thoratec Corp.
Published: 2019-03-30
License: https://open.fda.gov/license/

Abbott Medical / initiated 2019-03-30 / Terminated / root cause: manufacturing process

FDA source

Thoratec Corp. began a recall of Thoratec Heartmate 3 Sealed Outflow Graft with Bend Relief, Sterile, REF 105581US/105581, RX only, Part of Left Ventricular Assist Device (LVAD) UDI... on 2019-03-30. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2349-2019
Classification: Class II
Status: Terminated
Initiated: 2019-03-30
Posted: 2019-08-22
Terminated: 2020-08-24
Recalling firm: Abbott Medical
Product: Thoratec Heartmate 3 Sealed Outflow Graft with Bend Relief, Sterile, REF 105581US/105581, RX only, Part of Left Ventricular Assist Device (LVAD) UDI: 00813024013266
Product code: DSQ Ventricular (Assist) Bypass
Reason for recall: 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.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: 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,
Quantity in commerce: 149 outflow graft units
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 codes and lots: 105581/105581US: The shelf life is 60 months from date of manufacture. All batch/lot numbers 6613000 and below or 50000000 and higher. UDI/GMDN 00813024013266 / 61747

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2349-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2348-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-28	2019-08-22
Z-2349-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-28	2019-08-22

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)