BLOOMINGTON, Ind.--(BUSINESS WIRE)--Physicians will now have access to Cook Medical’s Word catheter, a silicone balloon catheter used to treat cysts of the Bartholin gland, company officials announced ...
The recall involves 17,827 devices globally and involves potential catheter tip fracture and/or separation. Nancy Crotti Cook Medical has issued the second major catheter recall due to tip splitting ...
FDA has issues a Class I designation for a Cook Medical catheter recall involving 95,167 devices around the world. Cook (Bloomington, IN) said Monday that it initiated the voluntary recall on July 2, ...
Potential for Delivery System Catheter Separation Prompts Cook Medical To Initiate Voluntary Global Recall of Zilver® PTX® Drug Eluting Stent Based on its investigation into a small number of ...
Bloomington-based Cook Medical has issued a voluntary recall of more than four million catheters with Beacon Tip technology. Cook says the catheters have been found to have degradation of the tip, ...
Balloon catheters are in abundant use across the human vasculature. Thus, the January U.S. FDA draft guidance for angioplasty and specialty catheters captured a range of critical devices. However, ...