S 60-F 124697Recalls & reported problems
BIOTRONIK SE & Co. KG · 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 04035479145057), received between Jan 29, 2019 and Jan 29, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “Delivered as Unsterile Product” (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.
Most reported problems
Device problems
- Delivered as Unsterile Product1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 29, 2019Delivered as Unsterile Product; Delivered as Unsterile Product
THE INNER PACKAGING OF THIS STYLET WAS NOT SEALED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8285924 ↗
Other STYLET, CATHETER devices
- LLD EZ Lead Locking Device 518-062Spectranetics Corporation · Stylet, Catheter18 deaths322 reports
- 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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