An FDA-recorded root-cause determination. The FDA lists 10 recalls with this root cause since 2025. Most recent report: Sep 30, 2026.
Communication to recommend reviewing the IFU and ensuring that all treatment preparation and handling steps are performed as instructed.
Boston Scientific's complaint investigations have identified that a subset of air ingress complaints are associated with hemostatic valve damage related to dilator insertion orientation during device preparation.…
Boston Scientific's complaint investigations have identified that a subset of air ingress complaints are associated with hemostatic valve damage related to dilator insertion orientation during device preparation.…
Boston Scientific's complaint investigations have identified that a subset of air ingress complaints are associated with hemostatic valve damage related to dilator insertion orientation during device preparation.…
Boston Scientific's complaint investigations have identified that a subset of air ingress complaints are associated with hemostatic valve damage related to dilator insertion orientation during device preparation.…
Due to adapter not being properly aligned or locked in place.
Due to a modification by a vendor and may be reinstalled without properly engaging the outside rear seat brackets that are used to keep the seat in place.
Due to an error when defining a new stereotactic reference that users fail to first change an already defined obsolete reference to a pre-plan reference.…
Due to an error when defining a new stereotactic reference that users fail to first change an already defined obsolete reference to a pre-plan reference.…
Emphasizing instructions for LVP duration programming located in the IFU.
Source: U.S. FDA openFDA device enforcement + RES recall records. Informational only — verify against the FDA before acting.