The FDA labeled the recall as a Class I, according to Boston Scientific. A Class 1 is the most serious type of recall issued by the federal watchdog, indicating “there is a reasonable probability that use of these products will cause serious adverse health consequences or death.”
Boston Scientific said it received 14 complaints over shaft separation issues, 4 of which involved separation of the distal shaft, all of which occurred during device preparation or use.
The company warned of possible embolism of device fragments during such a failure, which could lead to obstruction of blood flow and necessitate re-intervention to remove fragments, according to a press release.
Obstruction of blood flow could result in stroke, kidney damage or damage to the intestines or limbs. Boston Scientific said it has not received any reports of permanent injury or death due to the malfunction.
The Marlborough, Mass.-based company said all affected facilities were advised to discontinue use of the devices. The voluntary recall affects all UPNs of Chariot guiding sheaths.
Boston Scientific encouraged physicians to contact patients who’ve undergone procedures with the devices to confirm their status in case of possible malfunctions.
Boston Scientific warned doctors of the potential problem in October, after receiving 3 reports that the catheter’s guidewire fractured during procedures to remove plaque from the coronary arteries. In 1 case, the patient died 4 days after the wire fractured and the device’s rotating burr, moving at 195,000 to 200,000 rpm, pierced the artery wall, according to the FDA’s adverse events database.