SL orders withdrawal of 3 types of Indian cardiac stents over safety concerns

The National Medicines Regulatory Authority (NMRA) has reportedly instructed all state and private healthcare institutions to immediately withdraw 03 models of Drug-eluting coronary stents that have been identified as defective.

The affected stents are manufactured by Meril Life Sciences Pvt. Ltd., an India-based medical device company.

It has been reported that the use of these stents has led to several complications, including failure to position correctly within the patient’s coronary arteries, dislodgement of the stent, Acute Stent Thrombosis (sudden blood clotting), and failure of the stent to expand properly.

These issues were identified during an investigation conducted by the Medical Device Evaluation Committee (MDEC) of the NMRA.

According to circular number MSD/Q/S/2026/7 issued by the Medical Supplies Division (MSD), it has been highlighted that these stents pose a risk of causing various complications for patients.

In addition, it has been noted that these defects necessitate the use of supplementary devices, result in wasted time, and lead to inflated medical expenses.

Accordingly, 03 models of stents registered under the serial numbers SR 13501504, SR 13501409, and SR 13501506, alongside their corresponding batch numbers BLG 16 and BLG 11, have been withdrawn from clinical use. Sri Lanka Mirror