The FDA has posted 48 enforcement recalls from Boston Scientific Corporation since 2025, including 11 Class I (most serious) recalls. Most recent report: Sep 30, 2026.
Tip may fracture or detach, leading to device fragments remaining within the patient or migrating through the vasculature. Patient impact may include prolonged procedure or life-threatening embolism.
A subset of power adapters used with the connect console may exhibit higher-than-expected resistance in the electrical grounding path.…
There is potential for a delay in AF Burden Alert notification affecting the server software which supports the Insertable Cardiac Monitors (ICMs).…
There is potential for a delay in AF Burden Alert notification affecting the server software which supports the Insertable Cardiac Monitors (ICMs).…
There is potential for a delay in AF Burden Alert notification affecting the server software which supports the Insertable Cardiac Monitors (ICMs).…
Potential for arterial sheath tip separation or partial tip separation during use.
Device may fail to deploy the cinch implant and/or fail to cut the suture as intended.
Potential for arterial sheath tip separation or partial tip separation during use.
Device may fail to deploy the cinch implant and/or fail to cut the suture as intended.
Potential for breach in sterile barrier of device packaging.
Potential for breach in sterile barrier of device packaging.
Potential for breach in sterile barrier of device packaging.
Firm name as filed with the FDA: “Boston Scientific Corporation”. Related firm entities may file under separate names. Source: U.S. FDA openFDA device enforcement reports. Informational only — verify with the FDA before acting.