Recall Z-1774-2018
Abbott · initiated April 5, 2018
Class I – dangerous or defective products that could cause serious health problems or death
Product
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.
Codes / lots: United States: UDI: 00813024013297, Serial Numbers: MLP 000976, MLP 000989, MLP 000991, MLP 000999, MLP 001002, MLP 002020, MLP 002041, MLP 002048, MLP 002049, MLP 002056, MLP 002057, MLP 002058, MLP 002059, MLP 002066, MLP 002069, MLP 002070, MLP 002071, MLP 002072, MLP 002074, MLP 002075, MLP 002076, MLP 002080, MLP 002082, MLP 002084, MLP 002087, MLP 002088, MLP 002090, MLP 002091, MLP 002093, MLP 002096, MLP 002117, MLP 002118, MLP 002119, MLP 002120, MLP 002121, MLP 002123, MLP 002124, MLP 002125, MLP 002126, MLP 002127, MLP 002128, MLP 002130, MLP 002132, MLP 002133, MLP 002134, MLP 002135, MLP 002136, MLP 002137, MLP 002141, MLP 002144, MLP 002152, MLP 002155, MLP 002156, MLP 002157, MLP 002158, MLP 002159, MLP 002160, MLP 002162, MLP 002163, MLP 002161, MLP 002164, MLP 002165, MLP 002188, MLP 002189, MLP 002191, MLP 002192, MLP 002197, MLP 002198, MLP 002200, MLP 002201, MLP 002203, MLP 002204, MLP 002205, MLP 002206, MLP 002207, MLP 002208, MLP 002209, MLP 002211, MLP 002213, MLP 002214, MLP 002216, MLP 002217, MLP 002218, MLP 002219, MLP 002220, MLP 002221, MLP 002222, MLP 002223, MLP 002224, MLP 002226, MLP 002227, MLP 002228, MLP 002229, MLP 002236, MLP 002237, MLP…
Reason for recall
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.
FDA-determined cause: Device Design
Action taken
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.
Details
- Recall number
- Z-1774-2018
- Initiated
- April 5, 2018
- Posted by FDA
- May 17, 2018
- Terminated
- October 15, 2021
- Product code
- DSQ – Ventricular (Assist) Bypass
- Quantity
- 5,607
- Distribution
- 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…
- Recalling firm
- Abbott, Pleasanton, CA