Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 25–36 of 111 recalls
Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable resulting from difficulty deploying the stent is prolongation of the procedure to exchange the device for a new o…
Boston Scientific is initiating the removal of certain batches of Coyote" Over-the-Wire (OTW) Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter devices due to the potential for inflation/deflation d…
The potential for devices to experience inflation and/or deflation performance issues or difficulties.
The potential for devices to experience inflation and/or deflation performance issues or difficulties.
The potential for devices to experience inflation and/or deflation performance issues or difficulties.
The potential for devices to experience inflation and/or deflation performance issues or difficulties.
The potential for devices to experience inflation and/or deflation performance issues or difficulties.
The potential for devices to experience inflation and/or deflation performance issues or difficulties.
The potential for devices to experience inflation and/or deflation performance issues or difficulties.
Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes AC…
Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes AC…
Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes AC…