Three types of cardiac stents withdrawn immediately due to safety concerns

Colombo, June 19 (Daily Mirror) - The Medical Supplies Division (MSD) have ordered the immediate withdrawal of three types of 'inferior' cardiac stents and instructed hospitals across Sri Lanka to isolate all remaining stocks without using them, in a major nationwide safety alert affecting heart treatment services.

The directive comes as health authorities move swiftly to prevent potential risks to patients undergoing angioplasty procedures, after regulatory reviews found serious concerns regarding the performance and safety of the devices in clinical use. Hospitals have been told to urgently identify affected stocks, remove them from circulation, and ensure they are not used under any circumstances.

The decision involves coronary stents that are widely used to treat blocked arteries and improve blood flow in heart patients. According to health sector officials, the withdrawal is a precautionary but urgent measure aimed at protecting patient safety following warnings raised through regulatory assessments and expert evaluations.

Under the instructions issued by the National Medicines Regulatory Authority (NMRA), all Provincial Health Directors, Hospital Directors, and Heads of Medical Institutions have been directed to strictly enforce the recall. Remaining stocks of the affected stents must be set aside immediately and reported, while usage has been completely prohibited pending further investigation.

The MSD have highlighted that the move is necessary due to potential risks associated with the devices, including complications that could arise during or after cardiac procedures. Medical professionals have been advised to closely monitor patients who have already received the stents, as part of ongoing clinical safety surveillance.

The Division has also informed all relevant institutions to comply without delay, warning that failure to implement the directive could endanger patient safety. The circular has been circulated to major hospitals, including national and teaching hospitals, as well as regional health authorities, ensuring nationwide enforcement.

Meanwhile, discussions are continuing within the medical community over the need for a full investigation into how the stents were approved and distributed. Health officials have not yet confirmed whether further batches or related devices may also be reviewed, leaving the situation under close observation.

For now, hospitals remain on high alert as they work to remove the affected devices and ensure uninterrupted cardiac care services, while authorities stress that patient safety remains the top priority.

The controversy has intensified after Chairman of the Doctors' Trade Union Alliance for Medical and Civil Rights, Specialist Dr. Chamal Sanjeewa publicly called for a comprehensive investigation into the incident. He urged the Health Secretary to immediately disclose whether any patient deaths have occurred due to complications linked to the stents. His statement has added pressure on health authorities to provide clearer answers and publish full clinical findings.

Dr. Sanjeewa also requested that authorities conduct a transparent probe into how the stents entered the national supply chain and whether proper quality checks were followed before distribution to hospitals. His comments reflect growing concern within parts of the medical community about regulatory oversight and patient safety safeguards.