STIMULONG SONO 531156-35URecalls & reported problems
Pajunk GmbH Medizintechnologie · 531156-35U · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04048223117262), received between Feb 11, 2022 and Feb 11, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Separation” (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.
Most reported problems
Device problems
- Material Separation1
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.
MalfunctionFeb 11, 2022Material Separation; Material Separation
IRN# (B)(4). DR. WAS HAVING DIFFICULTY FEEDING THE CATHETER ONCE IT REACHED THE END OF THE TOUCHY NEEDLE AND DECIDED TO ABORT THE PROCEDURE AND PULLED THE CATHETER OUT. WHEN CATHETER WAS REMOVED HE NOTICED THE GOLD TIP OF THE CATHETER DID NOT RETURN AND WAS DISLODGED INSIDE THE PATIENT. HE DESCRIBED THAT HE COULD NOT RETRIEVE IT WITH THE TOUCHY NEEDLE AND WAS CONSULTING WITH THE SURGEON ON HOW TO REMOVE. DR. (B)(6) IS OFF FOR A COUPLE DAYS AND PLANNING ON MEETING WITH HIM NEXT WEEK TO GAIN MORE DETAILS. HE HAD TO SEND THE PRODUCT TO PATH/RISK AND HE IS NOT AWARE AS TO HOW THEY WILL RELEASE IT TO US FOR INVESTIGATION BUT WE WILL COVER WITH THEM IN OUR MEETING NEXT WEEK. ANOTHER PROCEDURE WAS DONE TO REMOVE THE PIECE LEFT BEHIND AND THEY WERE SUCCESSFUL IN REMOVING IT. (DOCTOR) DID NOT DISCLOSE IF THERE WERE ANY COMPLICATIONS.
Patient problems: Foreign Body In Patient
MAUDE report 13511667 ↗
Other Anesthesia conduction kit devices
- BD Luer-Lok, BD Glaspak 405671Becton, Dickinson And Company · Anesthesia conduction kit1 recall68 reports
- ARROW IPN922678Teleflex Incorporated · Anesthesia conduction kit2 recalls0 reports
- 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.
How reports and recalls are matched · Editorial policy · Report an error on this page