After Medline pulled off a massive $6.26 billion IPO late last year, the company now finds itself facing serious concerns being leveled by the FDA.
The company is a mammoth medical device distributor that has largely worked behind the scenes and out of the headlines to stock hospitals and operating rooms.
The FDA has put the firm back into the headlines, however, taking umbrage with its NAMIC brand Angiographic Control Syringes for certain heart procedures.
In a warning letter (PDF) dated March 25 and made public this week, the U.S. regulator said the company had failed to deal with issues identified during an inspection of Medline’s manufacturing site in Glens Falls, New York, as well as hundreds of complaints about its device.
This New York site creates both the syringes and procedure kits used to inject contrast dye into patients' blood vessels for several heart procedures.
The concerns date back to 2023, when “an increase in complaints” began to accumulate “regarding disconnection from manifolds you attributed to the presence of excess silicone,” according to the letter.
A year later, Medline deemed the risk “low,” a condition the FDA found “inconsistent with your design failure modes and effectiveness analysis,” the document goes on.
Medline’s own Health Hazard Evaluation found “air embolism" as being the highest-severity issue for loose connections, according to the FDA. The term describes when air is forced into patients' bloodstreams—a potentially fatal defect.
The FDA letter goes on to detail 221 complaints with 177 safety reports to regulators surrounding the device. This included one report “involving the injection of air into a patient and one involving biohazard exposure of a clinician,” the FDA said.
Earlier this year, Medline pledged to “conduct a removal of NAMIC Angiographic Control Syringes based on multiple discussions with the agency,” the FDA explains in the letter. A recall plan was put in place last month.
Medline also drew the FDA’s ire regarding inadequate cleaning practices at its manufacturing facility and weak safety tests.
A Medline spokesperson told Fierce Medtech: "Medline is committed to quality, patient safety and regulatory compliance. We are aware of the FDA Warning Letter following a recent inspection of our NAMIC facility. We take these matters seriously, are working directly with the FDA to address the observations and have initiated actions to strengthen our processes where needed."