HeartWare International (NSDQ:HTWR) said it’s issuing a "field correction" to cardiac surgeons, advising them to check a component of its HVAD implanted heart pump that’s been reported to fail in less than 0.004% of some 2,900 implants.
The Framingham, Mass.-based company said the rear portion of the left ventricular assist device’s driveline connector housing became partially or fully separated from the front of the driveline connector after extended use in 11 of 2,900 cases.
"In the unlikely event of a separation, a repair may be necessary. If left unattended, electrical connection to the controller could be affected and a VAD stop alarm could result. None of the confirmed events have resulted in harm to the patient," according to a press release. "In the event of a separation, hand-tightening of the connector housing may be sufficient as a temporary measure; however, healthcare professionals are instructed to contact HeartWare to arrange for an inspection and permanent repair by a HeartWare clinical engineer. No product replacement or exchange is required."
HeartWare said it’s in the process of changing its manufacture of the device to prevent future occurrences. The action is not expected to have much of an effect on HeartWare’s finances, according to the release.
"We believe this recall will prove to be a non-event as it should not impact: 1) HTWR’s ability to continue to drive U.S. bridge-to-transplant (BTT) market share and 2) [operating expenses] in a meaningful way," Leerink Swann analyst Danielle Antalffy wrote in a note to investors this morning. "Some key additional points from our follow-up call with HTWR: (1) Of the 11 patients who experienced a driveline disconnection, 6 had alarms sound and none of the 11 suffered serious adverse events; (2) This issue occurred on average 590 days after implant and involved both U.S. and EU patients; (3) HTWR is implementing a manufacturing fix that will directly attach the driveline housing to the cable, which should eliminate risk of disconnection. This manufacturing fix will be rolled out on Feb. 15th; (4) HTWR does not have to remove or replace any product from the market; (5) FDA has not yet classified the recall. Because these are life-saving devices, we believe FDA will likely classify this as Class I – the most serious level – much like other LVAD recalls in the past."
