WASHINGTON, D.C. — Medtronic, a global corporation involved in medical device development and production, announced another recall of one of its faulty medical devices. In this particular recall, which the U.S. Food and Drug Administration, or FDA, considers to be a Class I recall, Medtronic’s heart ventricular assist device (HVAD) and its system parts, such as the HVAD Pump Outflow Graft along with the Outflow Graft Strain Relief were recalled. According to Bloomberg Law News, the outflow graft of the HVAD pump is in danger of tearing away from its implant. A screw used for strain relief could break during the assembly process before the device is implanted in the patient. The FDA classifies this recall as one of its most urgent recall campaigns because of the threat to kill or significantly injure the patient wearing Medtronic’s HeartWare Device. The FDA indicated that a total of 4,924 devices are included in this recall campaign. Medtronic distributed the defective devices between March 1, 2018, to April 1, 2020.
Medtronic’s HVAD system helps transport blood around the patient’s body. Medtronic designed the device to aid patients who could die from left ventricular heart failure while waiting for a heart transplant. The recalled device is also used during heart tissue recovery, and as therapy for patients who are not scheduled for a heart transplant.
The FDA said that continued use of the recalled medical devices could inflict severe pain and harm to the patient. Injuries include loss of consciousness, fluid buildup around the heart, dizziness, bleeding, further medical procedures, and potentially death. At this time, Medtronic indicated it received 92 complaints regarding pre-implant pump assembly process failures, including relief screws breaking and grafts from the outflow tearing.
The FDA counsels that physicians must carefully examine the graft after assembling the device but before implanting it to discover any tears. The FDA also counseled physicians to continue performing pre- and post-operation examinations to detect any problems.
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