Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 1–12 of 48 recalls
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.
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.
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.