Dive Brief:
- Smiths Medical, now part of ICU Medical, notified customers May 29 that some Bivona adult and pediatric tracheostomy tubes have a manufacturing defect that may cause the device to tear, become displaced and contribute to a “catastrophic adverse event.”
- One death and 35 serious injuries were associated with the issue, according to the company’s Urgent Medical Device Notification, which the Food and Drug Administration published last week. The agency labeled the recall a Class I event, the severest classification.
- Smiths Medical has had a string of recalls involving infusion pumps, ventilators and syringe pumps. ICU Medical CEO Vivek Jain told investors at a conference on Friday that integrating the 2022 acquisition of the Smiths medical device business has proved more challenging than expected.
Dive Insight:
ICU Medical paid $2.35 billion to buy Smiths Medical from London-based industrial conglomerate Smiths Group, adding syringe and ambulatory infusion pumps and vascular access and vital care devices to its portfolio of hospital products.
However, a series of quality system issues that weakened customer relationships and hurt revenue have taken time to resolve, Jain said at the Morgan Stanley Global Healthcare Conference.
“We walked into a situation that we knew was going to be challenging, but it was more challenging than we had expected,” the CEO said.
Smiths Medical this year has recalled ambulatory infusion pumps and syringe pumps due to software problems and recalled emergency ventilators linked to eight serious injuries.
ICU Medical, which also inherited a warning letter in the Smiths acquisition, believes it can successfully integrate the business, as it did with its past acquisitions of Hospira Infusion Systems and Pursuit Vascular.
The San Clemente, California-based company has targeted cost reductions and plans to cut the number of its manufacturing sites to 10 facilities remaining by 2026, down from 20 sites in 2022. ICU Medical is also eliminating 83 jobs in Minnesota as it closes a service and distribution facility.
The Smiths business is beginning to turn the corner, Jain said at the conference. “It’s certainly moving in the right direction,” he said. “We’ve had a little bit of revenue growth and improving margins, and cash generation and a more stable balance sheet.”
In the tracheostomy tubes notice, Smiths Medical said problems can arise if the flange on the item is torn or broken, which can cause the tube to move from its position in the trachea. This could interfere with proper ventilation or protection of the airway.
The company instructed customers to check all inventories for the catalog numbers of affected devices and discard the products. Customers can receive a replacement product or credit.