EpiLong I Soft Tip Plus 0431157-51Recalls & reported problems
Pajunk GmbH Medizintechnologie · EpiLong · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 14048223013134), received between Mar 13, 2019 and Mar 13, 2019 — classified as 1 injury.
The most frequently reported specific device problem is “Material Split, Cut or Torn” (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 18, 2026.
Most reported problems
Device problems
- Material Split, Cut or Torn1
Patient problems
- Device Embedded In Tissue or Plaque1
- 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.
InjuryMar 13, 2019Material Split, Cut or Torn; Material Split, Cut or Torn
(B)(4). TENTATIVE SUMMARIZING TRANSLATION FROM INITIAL REPORTER´S NARRATIVE: PT UNDERWENT UNEVENTFUL IVOR LEWIS MINIMAL INVASIVE ESOPHAGECTOMY. ANALGESIA WAS ADMINISTERED THROUGH A THORACOSCOPIC PLACED PARAVERTEBRAL CATHETER PLACED BY THE SURGEON DURING THE OPERATION, WITH GOOD EFFECT. AFTER REMOVAL OF CATHETER, 5 DAYS POST OPERATION, THE NURSE NOTICED THE END OF THE CATHETER WAS DESTRUCTED.
Patient problems: Device Embedded In Tissue or Plaque; No Known Impact Or Consequence To Patient
MAUDE report 8415334 ↗
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- BD Luer-Lok, BD Glaspak 405672Becton, Dickinson And Company · Anesthesia conduction kit1 recall27 reports
- BD Luer-Lok, BD Glaspak 405673Becton, Dickinson And Company · Anesthesia conduction kit1 recall10 reports
- BD Luer-Lok, BD Glaspak 405637Becton, Dickinson And Company · Anesthesia conduction kit1 recall7 reports
- BD Luer-Lok, BD Glaspak 405707Becton, Dickinson And Company · Anesthesia conduction kit1 recall4 reports
- BD Glaspak 405675Becton, Dickinson And Company · Anesthesia conduction kit1 recall3 reports
- BD Luer-Lok, BD Glaspak 405609Becton, Dickinson And Company · Anesthesia conduction kit1 recall3 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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