SonoLong SoftSecure 521189-31ARecalls & reported problems
Pajunk GmbH Medizintechnologie · SonoLong SoftSecure SonoLong NanoLine® cannula 19G x 100mm with facet tip S and · Class 2
- 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 04048223088241), received between Jun 13, 2025 and Jun 13, 2025 — 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Material Split, Cut or Torn1
Patient problems
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 13, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
IRN# (B)(4). INCIDENT OCCURRED IN USA: DURING PLACEMENT OF A SUBGLUTEAL SCIATIC CATHETER USING THE SONOSOFT SECURE CATHETER, THE CATHETER SHEARED DURING LIGHT WITHDRAWAL THROUGH THE NEEDLE. WE WANTED TO REPORT THIS AS A POSSIBLE DEVICE MALFUNCTION. THE CATHETER WAS PLACED UNDER STERILE CONDITIONS AND WAS POSITIONED FAIRLY DEEP, SO WE DECIDED NOT TO ATTEMPT SURGICAL REMOVAL TO AVOID FURTHER TISSUE DAMAGE. THE PATIENT WAS INFORMED OF THE INCIDENT.
Patient problems: Foreign Body In Patient
MAUDE report 22200930 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.