SonoPlex® II Facet 001285-74Recalls & reported problems
Pajunk GmbH Medizintechnologie · SonoPlex® II Facet 22G (0,70) x 50mm, with injection tube and connecting cable · 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 04048223131008), received between Nov 11, 2025 and Sep 2, 2026 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Break” (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.
Reports received per month
Most reported problems
Device problems
- Break2
Patient problems
- Foreign Body In Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjurySep 2, 2026Break
Patient problems: Foreign Body In Patient
MAUDE report 50564542 ↗MalfunctionNov 11, 2025Break; Break
IRN# (B)(4). INCIDENT OCCURRED IN BELGIUM. TENTITIVE TRANSLATION: WHILE REPOSITIONING THE NEEDLE DURING LOCAL ANESTHESIA, THE NEEDLE BROKE OFF INSIDE THE PATIENT; FORTUNATELY, A SMALL PIECE WAS VISIBLE AND THE DOCTOR WAS ABLE TO REMOVE THE NEEDLE COMPLETELY.
Patient problems: Foreign Body In Patient
MAUDE report 23521676 ↗
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- ARROW IPN923597Teleflex Incorporated · NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)1 recall0 reports
- ARROW IPN922631Teleflex Incorporated · NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)1 recall0 reports
- ARROW IPN922605Teleflex Incorporated · NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)1 recall0 reports
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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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