Starting from 1 January 2022, active safety alerts related to medical devices listed under MDACS are listed below. For safety alerts before 1 January 2022, please refer to archive.
The United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA) has posted a medical device safety alert concerning Boston Scientific Corporation CRBS POLARSHEATH STEERABLE SHEATH [Material number: M004CRBS3050; Batch Number: 32895945, 32895947, 32903274, 32903275, 32903276, 32903277, 32903278, 32903340, 32999267, 33000331, 33000333, 33000334, 33000337, 33000338, 33000339, 33052646, 33052647, 33052648, 33052649, 33061576, 33171976] [HKMD number: 230430].
According to the MHRA, the manufacturer has identified a tooling error in manufacturing which may have caused delamination of the inner lumen of the sheath shaft in a subset of POLARSHEATH devices. This could result in the embolization of a fragment during use (such as flushing of the sheath or introduction of the dilator or ablation catheter). The most serious foreseeable harm that could occur if a liner fragment became dislodged and embolized during the procedure is a stroke. Other potential harms include myocardial ischemia or another distal vascular occlusion.
For further information, please visit https://mhra-gov.filecamp.com/s/d/eRxgzbBNK1eWTBPf
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 22 Feb 2024