Temporary Carotid Catheter For Embolic Capture
FDA adverse event reports and recall history for temporary carotid catheter for embolic capture (product code NTE), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 5,280
- Deaths
- 111
- Injuries
- 3,320
- Malfunctions
- 1,827
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2023-11-17Open, ClassifiedProcess control
Medtronic Mo.Ma Ultra Proximal Cerebral Protection Device, Model Number MUS0130069X6
The Mo.Ma Ultra device manifold is labelled with 2 stickers, an inferior and superior sticker, one on each side of the manifold. These stickers label the common carotid artery (CCA) proximal balloon and external carotid artery (ECA) distal balloon inflation and deflation ports. Both sides of the complaint units manifold were labelled with the superior label leading to an incorrect identification of the proximal and distal inflation /deflation ports when viewing the devices from the inferior side.
- 2023-11-17Open, ClassifiedProcess control
Medtronic Mo.Ma Ultra Proximal Cerebral Protection Device, Model Number MOM0130069X6
The Mo.Ma Ultra device manifold is labelled with 2 stickers, an inferior and superior sticker, one on each side of the manifold. These stickers label the common carotid artery (CCA) proximal balloon and external carotid artery (ECA) distal balloon inflation and deflation ports. Both sides of the complaint units manifold were labelled with the superior label leading to an incorrect identification of the proximal and distal inflation /deflation ports when viewing the devices from the inferior side.
- 2023-11-17Open, ClassifiedProcess control
Medtronic Mo.Ma Ultra Proximal Cerebral Protection Device, Model Number MOM0130068X5
The Mo.Ma Ultra device manifold is labelled with 2 stickers, an inferior and superior sticker, one on each side of the manifold. These stickers label the common carotid artery (CCA) proximal balloon and external carotid artery (ECA) distal balloon inflation and deflation ports. Both sides of the complaint units manifold were labelled with the superior label leading to an incorrect identification of the proximal and distal inflation /deflation ports when viewing the devices from the inferior side.
- 2023-05-11Open, ClassifiedVendor change control
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.
- 2023-05-11Open, ClassifiedVendor change control
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.
- 2023-05-11Open, ClassifiedVendor change control
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.
- 2023-05-11Open, ClassifiedVendor change control
ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 701814RMC
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.
- 2023-05-11Open, ClassifiedVendor change control
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.
- 2023-05-11Open, ClassifiedVendor change control
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.
- 2023-05-11Open, ClassifiedVendor change control
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.
Monitor temporary carotid catheter for embolic capture automatically
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