US FDA warns Medline over defective heart procedure syringes
April 8 (Reuters) - The U.S. Food and Drug Administration has told medical device maker Medline MDLN.O that its syringes used in heart procedures are defective and warned the company of penal actions if it fails to address the issues.
The warning letter, dated March 25, followed an FDA inspection in December 2025 at Medline's NAMIC division in Glens Falls, New York. The facility makes syringes and procedure kits used to inject contrast dye into patients' blood vessels during cardiovascular procedures.
The FDA said Medline did not take appropriate action after complaints in June 2023 over NAMIC syringes disconnecting from manifolds, a problem the company linked to excess silicone on the connectors.
It warned that failure to address the violations could result in seizure of products, court action or financial penalties.
A Medline spokesperson responded on Wednesday that the company takes "these matters seriously, are working directly with the FDA to address the observations and have initiated actions to strengthen our processes where needed."
According to the FDA letter, Medline got 221 complaints and filed 177 safety reports with regulators, including one case of air embolism, a potentially fatal condition caused by air entering the bloodstream, and another in which a clinician was exposed to a biohazard.
The health regulator said Medline's own internal risk analysis had identified the air embolism as the most serious possible failure. Still, the company rated the overall risk as low, a conclusion the FDA called inconsistent with its own data.
Medline's attempted fixes failed to stop the problem, with complaint rates rising throughout 2025 and breaching the company's safety limits every quarter, the FDA said.
The company eventually recalled the syringes and filed a product removal report in March 2026.
The FDA also cited the company for poor cleaning practices at its manufacturing facility and inadequate safety testing following design changes.
