Recall Z-1302-2024 · DRA Catheter, Steerable
Boston Scientific Corporation
Boston Scientific POLARSHEATH Steerable Sheath 12F, REF M004CRBS3050
| Date | Mar 26, 2024 (initiated Feb 12, 2024) |
| Status | Open, Classified |
| Reason | Boston Scientific 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). |
| Root cause | Process control |
| Action | Boston Scientific issued an Urgent Field Safety Notice - Urgent Medical Device Recall to its consignees on 02/12/2024 via hand delivery by sales representative. The notice explained the issue, potential risk, and requested the following actions be taken: Immediately cease distribution of the product and "1- Please immediately discontinue use of the Boston Scientific product reported in the list and remove all of the affected units from your inventory, regardless of where these units are stored in your facility. Segregate the units in a secure place, pending return to Boston Scientific. 2- |
| Quantity | 461 devices |
| Distribution | Austria, Belarus, Estonia, Finland, France, Germany, Great Britain, Greece, Ireland, Italy, Netherlands, Poland, Portugal, Spain, and Japan |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K223824 | POLARSHEATH Steerable Sheath 12F (UPN:M004CRBS3150), POLARMAP Circular Mapping Catheter (UPN:M004CRBS7210), POLARMAP Boston Scientific Corporation, Mar 22, 2023 |