Sri Lanka NMRA Orders Immediate Withdrawal of Defective Meril Life Sciences Stents
Sri Lankaβs National Medicines Regulatory Authority has ordered state and private medical centers to stop using three models of drug-eluting coronary stents immediately. The regulatory body issued the emergency directive after identifying critical manufacturing flaws that present immediate risks to cardiac patients undergoing angioplasty procedures.
Key Highlights
- The regulatory action impacts 3 specific models of drug-eluting coronary stents manufactured by India-based Meril Life Sciences.
- An official probe revealed dangerous malfunctions, including placement failure, device dislodgement, and sudden blood clotting.
- The defective devices have caused significant surgical delays, forced the use of secondary equipment, and increased healthcare costs.
- Medical authorities have listed the exact serial and batch numbers required for immediate clinical removal across Sri Lanka.
The National Medicines Regulatory Authority (NMRA) has 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 patientβs 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SR 13501504, SR 13501409, and SR 13501506, alongside their corresponding batch numbers BLG 16 and BLG 11, have been withdrawn from clinical use.
Future Outlook
The blanket withdrawal is expected to prompt stricter scrutiny of imported cardiovascular devices by the Medical Device Evaluation Committee. Moving forward, the NMRA will likely implement more rigorous pre-market validation protocols for foreign medical manufacturers to safeguard domestic patient health. Hospitals are currently auditing their inventories to ensure full compliance with the newly issued health ministry circular.
FAQs
Which stent models have been recalled by the NMRA?
The regulatory authority has banned three specific drug-eluting models registered under serial numbers SR 13501504, SR 13501409, and SR 13501506. The affected products belong to production batches BLG 16 and BLG 11.
Who is the manufacturer of the defective coronary stents?
The recalled cardiovascular devices are produced by Meril Life Sciences Pvt. Ltd., a medical device manufacturing corporation headquartered in India.
What clinical risks do these faulty medical devices pose to patients?
Investigating officials found that the stents can fail to expand or position correctly inside coronary arteries. Serious complications include device dislodgement and Acute Stent Thrombosis, which is a sudden, life-threatening blood clot.
How does this recall impact healthcare operations in Sri Lanka?
The defects force cardiologists to deploy additional secondary medical apparatus during emergency procedures. This technical failure results in wasted surgical time and significantly inflates overall medical expenses for both patients and healthcare facilities.
