Alerts

 
 
  • Alert Medtronic CRT-D and ICD Advisory Medtronic Inc has issued a warning about battery problems in 6300 implantable defibrillation devices, but said there is no safety concern for patients.
  • Alert Abbott Recalls Four Lots of Powersail PTCA Catheter The voluntary class I recall was prompted after the company received four reports of catheters with damage to the distal shaft.
  • Medtronic Pacemaker Advisory Now a Class-1 Recall The wire-separation issues in some of Medtronic's Kappa and Sigma pacemakers, which the company warned physicians about last month, may warrant device replacement in patients who are pacemaker dependent, according to the company.
  • Alert FDA Recalls IAB Catheters The FDA has issued a class 1 recall for a number of intra-aortic balloon pump catheters manufactured by Arrow International because of a fault in the connector of the pump tubing assembly. The problem could have serious consequences, the agency notes, although the company said this week there have been no reports of injury or death.