STIMULONG SONO 521187-32CRecalls & reported problems
Pajunk GmbH Medizintechnologie · 521187-32C · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04048223117095), received between Nov 20, 2024 and Mar 28, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Complete Blockage” (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.
Reports received per month
Most reported problems
Device problems
- Complete Blockage1
- Nonstandard Device1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 28, 2025Complete Blockage; Complete Blockage
IRN # 062-25_968 INCIDENT OCCURRED IN BRAZIL: DURING THE MATERIAL TESTING, IT WAS FOUND THAT THE DEVICE WAS OBSTRUCTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21717188 ↗MalfunctionNov 20, 2024Nonstandard Device; Nonstandard Device
(B)(4) COMPLAINT TOOK PLACE IN GERMANY. ORIGINAL TEXT GERMAN: DRAHT GAR NICHT VORSCHIEBBAR, HÄNGT IN DER KATHETERSCHNECKE FEST. DRAHT IST DIE VERBINDUNG ZUM STIMULIERBAREN KATHETER. TRANSLATION INTO ENGLISH: WIRE CANNOT BE ADVANCED AT ALL, IS STUCK IN THE CATHETER SCREW. THE WIRE IS THE CONNECTION TO THE STIMULABLE CATHETER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20734153 ↗
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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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