Dive Brief:
- Smiths Medical, now part of ICU Medical, has recalled certain implantable ports because of a manufacturing error, after two injuries were reported. The defect can cause the plastic port housing to separate from the port reservoir, according to a notice posted Wednesday by the Food and Drug Administration.
- The recall, which instructs customers and distributors to remove the port devices from the market and return them, comes as Smiths has warned separately of a size problem with some oral/nasal endotracheal tubes. The company received eight reports of serious injury potentially related to the tube size issue.
- ICU Medical has juggled multiple Smiths recalls and quality issues since acquiring the business in 2022 from London-based conglomerate Smiths Group to expand its lineup of infusion therapy products.
Dive Insight:
ICU Medical, which gained Smiths’ syringe and ambulatory infusion pumps and vascular access and vital care devices in the $2.35 billion acquisition, is working to integrate the business into its existing operations.
That has proved harder than anticipated, due to a series of quality system issues, CEO Vivek Jain told investors last fall. ICU Medical also inherited an October 2021 warning letter stemming from a Minneapolis facility inspection in the deal.
“If we fail to effectively complete the integration of our business in a manner that preserves our reputation with customers and the key aspects of our corporate culture, our business, financial condition and results of operations could be harmed,” ICU Medical said, referring to the acquisition, in its annual report filed Feb. 27.
Smiths told customers in a Feb. 13 letter to stop using the ProPort implantable ports and return them to the company. The devices are part of a system for accessing patients’ veins.
Patients with an implanted device should be monitored for any signs of adverse events, and clinicians should ensure the housing and reservoir feel secure and stable when palpating the portal.
Serious health consequences including death, air entering the bloodstream or complications from the interruption of therapy are possible due to the defect.
On March 7, Smiths said it issued an urgent medical device correction to notify customers of a possible problem with the 2.0, 2.5, 3.0 and 3.5 mm sizes of its intubation oral/nasal endotracheal tubes. The products could be smaller than expected, resulting in inadequate ventilation to the patient. Patients could experience inadequate oxygen supply, underdose or cardiopulmonary collapse, which could lead to death.
Customers and distributors received instructions for determining if devices are affected.
