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# Boston Scientific Recalls PolarSheath Steerable
- URL: https://www.fdaweb.com/boston-scientific-recalls-polarsheath-steerable/
- Published: 2024-03-27T12:00:00.000Z
- Updated: 2026-09-14T14:26:40.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5156648

Boston Scientific has recalled the PolarSheath Steerable Sheath 12F after the company identified a tooling error in manufacturing which may have caused delamination of the inner lumen of the sheath shaft in a subset of devices. If delamination should happen, 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), an FDA [recall notice](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=206263&ref=fdaweb.com) says, which attributes the recall to a process control failure. Boston Scientific issued an urgent field safety notice last month that explained the issue, potential risks, and requested that healthcare providers immediately discontinue use of the affected products.