NovaCross XtremeRecalls & reported problems
Nitiloop Ltd · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07290017436012), received between Feb 14, 2020 and Feb 14, 2020 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Fracture” (2 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Fracture2
Patient problems
- No Consequences Or Impact To Patient2
- Peripheral Vascular Disease2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 14, 2020Fracture; Fracture
TIP OF DEVICE BROKE OFF IN SUBINTIMAL SPACE OF TIBIAL ARTERY. LEFT IN PLACE. PROCEDURE COMPLETED SUCCESSFULLY.
Patient problems: No Consequences Or Impact To Patient; Peripheral Vascular Disease
MAUDE report 9714168 ↗MalfunctionFeb 14, 2020Fracture; Fracture
TIP OF DEVICE BROKE OFF IN CALCANEAL ARTERY. LEFT IN PLACE. THE USER PLACED A STENT TO ATTACH THE TIP TO THE ARTERY ENDOTHELIUM. PROCEDURE COMPLETED SUCCESSFULLY.
Patient problems: No Consequences Or Impact To Patient; Peripheral Vascular Disease
MAUDE report 9711168 ↗
Other Catheter, Percutaneous devices
- WATCHMAN FXD Curve™ Access System M635TU80020Boston Scientific Corporation · Catheter, percutaneous1 recall47 deaths654 reports
- NA C315HIS02Medtronic, Inc. · Catheter, percutaneous1 recall369 reports
- WATCHMAN TruSteer™ Access System M635TU90050Boston Scientific Corporation · Catheter, percutaneous1 recall28 deaths302 reports
- Guidezilla™ II H7493933515060Boston Scientific Corporation · CATHETER, PERCUTANEOUS1 recall3 deaths278 reports
- Velocity Delivery Microcatheter VEL160STR-APenumbra, Inc. · CATHETER, PERCUTANEOUS297 reports
- Guidezilla™ H7493924215050Boston Scientific Corporation · CATHETER, PERCUTANEOUS294 reports
- WATCHMAN™ TruSeal™ Access System M635TU70020Boston Scientific Corporation · Catheter, percutaneous1 recall11 deaths217 reports
- Lantern Delivery Catheter PXSLIMLAN135T45Penumbra, Inc. · CATHETER, PERCUTANEOUS220 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page