Product group Injections / Infusions / Transfusions / Dialysis - catheters
Reference 01723/12

Due to manufacturing variability, some catheters in the affected lots may have endoscope stops with weaker than desired bond strengths. If the endoscope stop dislodges (comes loose) during clinical use of the catheter, it is possible that the endoscope could put a hole in the EAS balloon.

Recall of CardioFocus Endoscopic Ablation System (EAS) – HeartLight Catheters Lots 7957, 7975, 8006 and 8011, CardioFocus, Inc. , Download_VeroeffentlichtAm_EN 2012.04.10 PDF, 203KB, File does not meet accessibility standards