United States of America. The manufacturer of a coronary stent delivery system (NIR ON Ranger with Sox; Boston Scientific Corporation) has announced that it has stopped distribution and is voluntarily withdrawing the product from the market due to a serious risk of patient injury. The Sox system is one of two delivery systems marketed for the stent.
The Food and Drug Administration considers the withdrawal to be a total product recall and urges hospitals to immediately stop using this device because of potential risk to patients.
The device is implanted in patients to help keep open previously blocked heart arteries after the blockage has been cleared. The company took the decision after receiving more than 100 reports of balloon leakage, including 26 injuries and one death.
The company has stated that the reports of injury were possibly attributable to a change in the manufacturing process that affected the balloon only.
There are two delivery systems for the NIR ON Ranger: one with Sox and one without. As the firm has recalled the NIR ON Ranger with Sox, the NIR ON Ranger without Sox will continue to be available. The company has evaluated the system and informed the FDA that it performs as specified and as labelled.
Reference: HHS News P98-29 dated 8 October 1998.