openFDA Device Enforcement
Report-date coverage
June 20, 2012–July 08, 2026
Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall
event_date_initiated coverage
June 01, 1997–June 30, 2026
Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.
Product dates, classifications, firms, and source wording remain attached to their individual rows.
Opening this dossier never hides products that did not match a prior timeline filter.
device · product 1 of 14
ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 401814RMC
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.
These labels are deterministic app interpretations, not FDA categories.
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.
Code information
UDI/DI 20705032053508; Lot Numbers: 35262517, 35263334, 35264204, 35264222, 35265345.
Distribution pattern
Worldwide distribution.
device · product 2 of 14
ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 501814RMC
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.
These labels are deterministic app interpretations, not FDA categories.
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.
Code information
UDI/DI 20705032054802; Lot Numbers: 35264208, 35264212, 35265329, 35265654, 35265649, 35265667.
Distribution pattern
Worldwide distribution.
device · product 3 of 14
ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 601814RMC
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.
These labels are deterministic app interpretations, not FDA categories.
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.
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.
These labels are deterministic app interpretations, not FDA categories.
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.
Code information
UDI/DI 20705032056851; Lot Numbers: 35265661
Distribution pattern
Worldwide distribution.
device · product 5 of 14
ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 801814RMC
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.
These labels are deterministic app interpretations, not FDA categories.
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.
Code information
UDI/DI 20705032056943; Lot Numbers: 35265335, 35264202
Distribution pattern
Worldwide distribution.
device · product 6 of 14
ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 603014MC
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.
These labels are deterministic app interpretations, not FDA categories.
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.
Code information
UDI/DI 20705032056790; Lot Numbers: 35265492
Distribution pattern
Worldwide distribution.
device · product 7 of 14
ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 501814REC
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.
These labels are deterministic app interpretations, not FDA categories.
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.
Code information
UDI/DI 20705032054789; Lot Numbers: 35264223
Distribution pattern
Worldwide distribution.
device · product 8 of 14
ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 401814RM
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.
These labels are deterministic app interpretations, not FDA categories.
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.
Code information
UDI/DI 20705032053492; Lot Numbers: 35265339, 35265670
Distribution pattern
Worldwide distribution.
device · product 9 of 14
ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 501814RE
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.
These labels are deterministic app interpretations, not FDA categories.
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.
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.
These labels are deterministic app interpretations, not FDA categories.
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.
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.
These labels are deterministic app interpretations, not FDA categories.
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.
Code information
UDI/DI 20705032056820; Lot Numbers: 35264219, 35265391, 35265392, 35265399, 35265668, 35265660
Distribution pattern
Worldwide distribution.
device · product 12 of 14
ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 601814RM
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.
These labels are deterministic app interpretations, not FDA categories.
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.
Code information
UDI/DI 20705032056738; Lot Numbers: 35265658, 35264211, 35264225, 35265647
Distribution pattern
Worldwide distribution.
device · product 13 of 14
ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 501814RM
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.
These labels are deterministic app interpretations, not FDA categories.
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.
Code information
UDI/DI 20705032054796; Lot Numbers: 35265644
Distribution pattern
Worldwide distribution.
device · product 14 of 14
ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 801814RE
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.
These labels are deterministic app interpretations, not FDA categories.
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.
