NA 6057-58 (UDI 00763000058937)Recalls & reported problems
Medtronic, Inc. · STYLET 6057-58 STRGHT BALL GLBL EIFU · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- 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 00763000058937), received between Oct 28, 2025 and Oct 28, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Packaging Problem” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Packaging Problem1
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.
MalfunctionOct 28, 2025Packaging Problem; Packaging Problem
IT WAS REPORTED THAT PRIOR TO USE THE STYLETS STERILE BARRIER WAS BREACHED. IT WAS NOTED THAT A CONTAINER WITH A BAG OF ICE WAS INAD VERTENTLY LEFT NEAR STYLETS AND ICE SEEPED INTO THE STYLET PACKAGING. IT WAS NOTED THAT WATER INSULATION WAS FOUND IN STYLET PACKAGING. THE STYLETS WERE ATTEMPTED/NOT USED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23400761 ↗
Other STYLET, CATHETER devices
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- LLD #2 Lead Locking Device 518-019Spectranetics Corporation · Stylet, Catheter2 deaths62 reports
- LLD EZ Lead Locking Device 518-067Spectranetics Corporation · Stylet, Catheter1 death23 reports
- Liberator Beacon Tip G26550Cook Vandergrift Inc. · STYLET, CATHETER2 deaths20 reports
- LLD E Lead Locking Device 518-039Spectranetics Corporation · Stylet, Catheter18 reports
- LLD #2 Lead Locking Device 518-022Spectranetics Corporation · Stylet, Catheter10 reports
- LLD #1 Lead Locking Device 518-018Spectranetics Corporation · Stylet, Catheter7 reports
- NA 6057-58Medtronic, Inc. · STYLET, CATHETER2 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.
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