Thoratec HeartMate 3 LVAS Implant Kit, Rx Only, Catalog # 106524US, 106524, 10652INT - LVAS KIT, HM 3 Indicated for providing short-term hemodynamic support in patients with advanced refractory left ventricular heart failure.
Recall
- Recall Number
- Z-1774-2018
- Event Number
- 79893
- Firm
- Abbott
- FEI Number
- 2916596
- Product Code
- DSQ
- Status
- Terminated
- Root Cause
- Device Design
- Initiated
- April 5, 2018
- Posted
- May 17, 2018
- Terminated
- October 15, 2021
- Address
- 6035 Stoneridge Dr, Pleasanton, CA, 94588-3270
Description
Thoratec HeartMate 3 LVAS Implant Kit, Rx Only, Catalog # 106524US, 106524, 10652INT - LVAS KIT, HM 3 Indicated for providing short-term hemodynamic support in patients with advanced refractory left ventricular heart failure.
Reports of outflow graft twist occlusions. Patients whose devices experience outflow graft occlusions will experience a persistent low flow alarm. Outflow graft occlusions can result in serious adverse events such as hemodynamic compromise, thrombus, and death.
Customers were notified via an Important Medical Device Advisory letter, dated 04/05/2018, that the firm has received reports of outflow graft twist occlusions in the HeartMate 3 (HM3) Left Ventricular Assist System. As a result, patients whose devices experience this issue will experience a persistent low flow alarm. Outflow graft twist occlusions can result in serious adverse events such as hemodynamic compromise, thrombus, and death. Physicians managing patients that will be implanted or already implanted with HM3 devices should follow the recommendations provided in the letter. Additionally, physicians managing patients that exhibit a persistent low flow alarm should determine patient care recommendations based on each unique clinical case. Questions should be directed to customers' local Abbott MCS Clinical Specialist or MCS HeartLine 1-800-456-1477. The firm issued a press release, dated 05/04/2018, notifying physicians about a field corrective action related to the HeartMate 3 Left Ventricular Assist Device (LVAD). Outflow graft twisting could occur post-implant in the HeartMate 3 LVAD, resulting in a persistent low flow alarm that may signal a potential safety risk to patients, such as low blood flow or clotting. No devices are being recalled from patients or hospitals as a result of the corrective action, and the recommendations made by the firm remain in place for physicians managing patients implanted with HeartMate 3. On 10/17/2018, the firm mailed an Urgent Medical Device Correction notice to consignees informing them that the Outflow Graft Clip was now available. The Outflow Graft Clip is intended to be used with all new patient implants and may be used on patient cases where an Outflow Graft twist is confirmed and surgical intervention is required. All HM3 implanting centers are required to be trained on the proper attachment of the clip prior to use of the clip.
Worldwide Distribution -- U.S., including the states of MN, PA, IL, WI, AZ, AR, TN, MO, TX, MA, NE, MI, CA, NC, OH, NY, GA, VA, FL, OK, MD, ME, SC, IN, LA, OR, WA, AL, CO, IA, KS, KY, UT, DC, and CT; and, the countries of Australia, Austria, Belgium, Brazil, Brunei, Canada, Cayman Islands, Colombia, Croatia, Czech Republic, Denmark, Egypt, France, Germany, Greece, Hong Kong, Hungary, India, Italy, Kuwait, Lebanon, Malaysia, Montenegro, Netherlands, Poland, Qatar, Romania, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, Spain, Sweden, Switzerland, United Arab Emirates, and United Kingdom.
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