US FDA warns Medline over defective heart procedure syringes

April 8 (Reuters) - The U.S. Food and Drug Administration has warned medical device maker Medline MDLN.O that its syringes used in heart procedures are defective and that the company has failed to fix the problem adequately.

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 manufactures 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 rose in June 2023 over NAMIC syringes disconnecting from manifolds, a problem the company linked to excess silicone on the connectors.

According to the letter, Medline received 221 complaints and filed 177 safety reports with regulators, including one case where air was injected into a patient and another where a clinician was exposed to a biohazard.

The health regulator said Medline's own internal risk analysis had identified air embolism, a potentially fatal condition caused by air entering the bloodstream, as the most serious possible failure. Despite this, 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 own safety limits every quarter.

The company eventually recalled the syringes after talks with the FDA and filed a product removal report in March 2026.

The FDA also cited the Northfield, Illinois-based company for poor cleaning practices at its manufacturing facility and for inadequate safety testing following design changes.

It warned that failure to address the violations could result in seizure of products, court action or financial penalties.

Medline, which made its Nasdaq debut last year and has a market value of $56.7 billion, did not immediately respond to a Reuters request for comment.