More than 110,000 iCross Coronary Imaging catheters have been recalled because the tip of the catheter can break off while inside the blood vessel. The catheters are used by doctors and hospitals in coronary intervention procedures to conduct ultrasound imaging. The catheters subject to the recall included catheters that were provided as a replacement for catheters that were recalled earlier this year for the same problem.
The manufacturer of the defective medical device, Boston Scientific, says that the problem occurs when the material used in the catheter becomes brittle. The company reports that, to date, there have been eight instances of the catheter tips breaking off during a procedure because the material had become too brittle. Apparently it is impossible to detect that the tip has become brittle prior to its use. This leaves practitioners with no means of determining the safety of the device, thus requiring a recall of all of the devices.
When the tip of the catheter breaks off inside a blood vessel, it can cause damage to the wall of the vessel and lead to a number of serious complications including death. Patients are at additional risk of injury when the tip breaks off because surgeons then will be required to retrieve the object.
The Food and Drug administration has determined this to be a Class I recall, meaning that there is a reasonable probability that use of this product will cause serious adverse health effects or death.
Source: Reuters, "FDA extends recall on Boston Scientific's catheters," June 14, 2011