SilverHawk™ P4044 (UDI 00763000918927)Recalls & reported problems
Medtronic, Inc. · ATHERECTOMY P4044 EXL SILVERHAWK BTK UNI · Class 2
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00763000918927), received between Jun 6, 2025 and Jun 6, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).
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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 6, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE SILVERHAWK DEVICE TIP DETACHED DURING CLEANING AFTER USE IN A PROCEDURE TO TREAT A PERIPHERAL ARTERY LESION IN THE ANTERIOR TIBIAL ARTERY. THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT, AND THE CASE WAS COMPLETED WITHOUT COMPLICATIONS OR ISSUES. THE GUIDEWIRE LUMEN WAS NOT TORN/RIPPED. THE VESSEL WAS PRE-DILATED USING A NON-MEDTRONIC DEVICE.THE PROCEDURE WAS COMPLETED WITH NO COMPLICATIONS OR ISSUES. NO PATIENT INJURY OR HEALTH CONSEQUENCES OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22160157 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.