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 corpus and the live FDA recall database.
- Total reports
- 5,311
- Deaths
- 112
- Injuries
- 3,335
- Malfunctions
- 1,842
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused twice in 2026 during FDA reporting-system changes and has since resumed.
Recent recalls
- 2026-08-20Open, ClassifiedUnder Investigation by firm
Boston Scientific ENROUTE Transcarotid Neuroprotection System, Material Number SR-200-NPS; Percutaneous catheter
Potential for arterial sheath tip separation or partial tip separation during use.
- 2026-08-20Open, ClassifiedUnder Investigation by firm
Boston Scientific ENROUTE Transcarotid Neuroprotection System Plus, Material Number SR-250-NPS; Percutaneous catheter
Potential for arterial sheath tip separation or partial tip separation during use.
- 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.
Monitor temporary carotid catheter for embolic capture automatically
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