InfiltraLong set consisting of: 001158-10ARecalls & reported problems
Pajunk GmbH Medizintechnologie · InfiltraLong set consisting of: InfiltraLong catheter 19G x 500mm with integrated metal spiral with 30 drill · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 14048223016036), received between Nov 23, 2018 and May 24, 2019 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Material Rupture” (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 18, 2026.
Most reported problems
Device problems
- Material Rupture2
- Fracture1
- Material Split, Cut or Torn1
Patient problems
- Foreign Body In Patient2
- Device Embedded In Tissue or Plaque1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 24, 2019Material Rupture; Material Split, Cut or Torn; Material Rupture; Material Split, Cut or Torn
IRN# 627_146-19. INITIAL REPORTER´S NARRATIVE: IN ATTEMPT TO REMOVE 001157-10A CATHETER AFTER 2 DAYS OF USE ON A C-SECTION PATIENT, THE DOCTOR NOTICED THAT PART OF THE CATHETER BROKE OFF. THE BROKEN PORTION OF CATHETER IS SCHEDULED TO BE REMOVED.
Patient problems: Foreign Body In Patient
MAUDE report 8639207 ↗InjuryNov 23, 2018Fracture; Material Rupture; Fracture; Material Rupture
IRN# (B)(4). CATHETER RUPTURED DURING REMOVAL. PIECE OF 20CM REMAINED IN PATIENT. HAD TO BE SURGICALLY REMOVED.
Patient problems: Device Embedded In Tissue or Plaque; Foreign Body In Patient
MAUDE report 8099226 ↗
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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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