Challenging times can often be the true test of the strength of a team.
In April, our teams faced one of those challenges when we decided to recall all products with Beacon Tip technology. Customers were telling us that, in some cases, the catheter tip was fracturing or separating. Decisions of this magnitude are never easy, but because of the potential impact to patients, a recall was the right thing to do.
The Beacon Tip issue is complicated and may have several causative factors that will take time to understand and resolve. Knowing how important these products are to physicians, we immediately dispatched teams to the field and to testing labs to identify the root causes and find a solution.
In the meantime, we have ramped up production on alternative products to get tools into the hands of our customers as quickly as possible. Cook Engineering and Regulatory teams have also been working around the clock to expand our product portfolio to address other clinical gaps.
“We know how important these devices are to physicians who use them every day. We heard from our customers that they needed a Cook catheter, so we moved quickly to find a solution,” said Mark Breedlove, vice president and global business unit leader of Cook’s Peripheral Intervention division.
The largest product line affected by the recall is the 5 Fr Beacon Tip Catheter that was manufactured in our Canton, Illinois, facility. The Canton team quickly re-tooled the production facility and trained additional employees to build alternative products. In just over a month, we’ve been able to fill 50% of the demand for products using the Beacon Tip technology with an alternative such as the Torcon NB Advantage Catheter.
“People from all corners of this the organization have come together to support our customers,” Mark said. “I’m proud of all of them for stepping up to meet this challenge head on.”
Refer to the Torcon NB Advantage Catheter product page for the complete Instructions for Use.