On 28-May-2020, US-FDA has released a recall alert for class I medical Device–HeartWare HVAD Pump Outflow Graft and Outflow Graft Strain Relief

Device Use:

“HeartWare HVAD Pump Outflow Graft and Outflow Graft Strain Relief” are the parts of HeartWare Ventricular Assist Device (HVAD) System which help the heart in delivering blood to the rest of the body. The HVAD system is used as a bridge to cardiac transplant in patients who are at risk of death from end-stage left ventricular heart failure, for heart tissue recovery, or as destination therapy (DT) in patients where new transplants are not planned.

Device Issue:

Medtronic (the manufacturer of this device medical device)-recalled this device due to the tear of outflow graft of the HVAD Pump and the strain relief screw might break during assembly prior to implant but might not be observed until  during or after the pre-implant pump assembly and attachment to the HVAD pump. Use of these affected devices might cause serious patient harm including dizziness, loss of consciousness, bleeding, accumulation of fluids around the heart, requiring additional medical procedures and death.

Device Case Reports:

Medtronic has received 92 medical device incident reports (complaints) pertaining to the pre-implant pump assembly process, which includes both the strain relief screw breaking and outflow graft tears. 38 complaints were associated with strain broken strain relief screws and 54 complaints were associated with outflow graft tears with two fatal case reports (2 patients died due to outflow graft tears). These tears might result in bleeding and could led to critical patient harm at a rate of 0.13%. With outflow graft tears, there is a potential for peri-operative/post-operative bleeding. This possibility should be considered in patients being treated for post-operative bleeding.

Class I MD recall:

is device falls under the category of Class I medical device, as per the classification system by US-FDA. This is the most serious type of recall because use of these devices might cause serious injuries or death.

Recalled Devices:

On 03-Apr-2020, Medtronic initiated the recall for total 4,924 devices which were distributed during the period of 01-Mar-2018 to 01-Apr-2020. The below models of the device were affected with recall.

Device Design:

Medtronic has updated the design of device to reduce the risk of damage during the assembly of the outflow graft and strain relief and attachment onto the pump during the pre-implant procedure. Company is now working with the FDA for approval of the change in device design.

Voluntary MD Incident/complaints reporting:

Health care professionals and consumers are advised to report the adverse reactions or quality problems experienced with the use of this medical device to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.

• Complete and voluntarily submit the report Online.
• Regular Mail or Fax: Download form FDA’s MedWatch zone, or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800- FDA-0178.