INFILTRALONG 001158-30CRecalls & reported problems
Pajunk GmbH Medizintechnologie · 001158-30C · Class 2
Data updated Oct 16, 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 04048223049624), received between Apr 28, 2025 and Apr 28, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Break” (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
- Break1
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.
InjuryApr 28, 2025Break; Break
IRN# (B)(4), INCIDENT OCCURRED IN AUSTRALIA: "PT HAD A BRACHIAL PLEXUS BLOCK PLACED DURING SURGERY ON THE (B)(6) 2025. THE CATHETER WAS FOR REMOVAL ON (B)(6) 2025. ON REMOVAL BY NURSING STAFF THE PLASTIC SEPARATED FROM THE METAL COIL AND THE COIL REMAINED STUCK IN THE PATIENTS WOUND. THE METAL WAS THEN REMOVED BY THE SURGEONS AND AN X-RAY WAS PERFORMED. I HAVE NOT YET HEARD THE RESULTS OF X-RAY.
Patient problems: Foreign Body In Patient
MAUDE report 21916576 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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