FDA (Devices) recall action 85227
The FDA (Devices) publishes a recall like this one as 12 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 12 pages.
An increase in the rate of complaints for difficulty or inability to track over the guidewire, may result in a procedural delay due to the need to exchange the affected device
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Boston Scientific is recalling 50 units of Stretch VL Ureteral Stent Sets due to increased complaints about difficulty tracking over the guidewire, which may cause procedural delays.
Boston Scientific is recalling 40 units of Stretch VL Ureteral Stent Sets because they may be difficult to track over a guidewire, potentially delaying procedures.
Boston Scientific is recalling 32 Percuflex Plus Ureteral Stent Sets due to increased complaints about difficulty tracking over the guidewire, which may cause procedural delays.
Boston Scientific is recalling Contour VL Ureteral Stent Sets due to an increased rate of complaints regarding difficulty tracking over the guidewire.
Boston Scientific is recalling Sensor Nitinol Wires because an increased rate of complaints indicates difficulty tracking over the guidewire, which may cause procedural delays.
Boston Scientific is recalling specific lots of Sensor Nitinol Wire with Hydrophilic Tip because increased complaints indicate difficulty tracking over the guidewire, which may cause procedural delays.
Boston Scientific is recalling 19 Polaris Ultra Ureteral Stent Sets due to an increased rate of complaints regarding difficulty tracking over the guidewire.
Boston Scientific is recalling 225 units of Sensor Nitinol Wire with Hydrophilic Tip due to increased complaints about difficulty tracking over the guidewire.
Boston Scientific is recalling 5 units of Percuflex Plus Ureteral Stent Sets due to an increased rate of complaints regarding difficulty tracking over the guidewire.
Boston Scientific is recalling 57 units of Stretch VL Ureteral Stent Sets because they may be difficult to track over a guidewire, potentially delaying procedures.
Boston Scientific is recalling Sensor Nitinol Wires with Hydrophilic Tips because an increased rate of complaints indicates difficulty tracking over the guidewire, which may cause procedural delays.
Boston Scientific is recalling 91 Percuflex Plus Ureteral Stent Sets due to increased complaints about difficulty tracking over the guidewire, which may cause procedural delays.