FDA (Devices) recall action 91922
The FDA (Devices) publishes a recall like this one as 14 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 14 pages.
There is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath which include but are not limited to situations of an intra-procedural delay, unplanned percutaneous or surgical intervention, or stroke; while a replacement device is prepared.
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.
Cordis US Corp is recalling the ANGIOGUARD RX / XP Emboli Capture Guidewire System because the device may separate during procedures, risking stroke or requiring emergency intervention.
The ANGIOGUARD RX/XP Emboli Capture Guidewire System may separate during medical procedures, potentially delaying treatment or requiring unplanned intervention. The recall affects 471 units distributed worldwide.
ANGIOGUARD RX/XP emboli capture guidewire systems may separate from their delivery sheaths during interventional procedures, potentially causing stroke. Cordis is recalling 56 units distributed worldwide.
The ANGIOGUARD RX/XP Emboli Capture Guidewire System may separate from its delivery sheath during medical procedures, potentially causing stroke or requiring emergency surgery. Cordis US Corp is recalling 146 units worldwide.
Cordis's Angioguard RX/XP Emboli Capture Guidewire System is recalled due to potential separation of the delivery system and capture sheath, which could cause procedural delays, unplanned intervention, or stroke during use.
Cordis US Corp is recalling the ANGIOGUARD RX/XP Emboli Capture Guidewire System (1,087 units worldwide) due to potential separation of the delivery system and capture sheath, which could lead to stroke.
Cordis is recalling an emboli capture guidewire system due to potential separation of components during medical procedures. The separation could cause procedural delays, unplanned interventions, or stroke.
Cordis has recalled 684 units of ANGIOGUARD RX/XP Emboli Capture Guidewire System due to potential separation of the delivery system and capture sheath during use, which could cause stroke or require unplanned surgical intervention.
Cordis US Corp recalls 54 units of the ANGIOGUARD RX/XP Emboli Capture Guidewire System due to potential separation of device components. This could delay procedures or result in unplanned intervention, including possible stroke.
The ANGIOGUARD RX / XP emboli capture guidewire system may separate from its delivery sheath during medical procedures, potentially leading to stroke or complications requiring emergency intervention.
The FDA has recalled the ANGIOGUARD RX/XP Emboli Capture Guidewire System because the delivery system and capture sheath could separate during use, potentially causing stroke or requiring emergency surgery.
Cordis US Corp is recalling ANGIOGUARD RX/XP Emboli Capture Guidewire Systems worldwide due to potential separation of the delivery system and capture sheath during procedures, which could cause stroke or require emergency intervention.
The ANGIOGUARD RX/XP Emboli Capture Guidewire System is being recalled because the delivery system and capture sheath may separate during procedures, potentially causing stroke or requiring emergency surgical intervention.
Cordis US Corp's ANGIOGUARD RX/XP Emboli Capture Guidewire System is being recalled by the FDA (Class I) because the delivery system and capture sheath may separate during medical procedures, potentially requiring emergency intervention.