Cadwell 302875-000Recalls & reported problems
Technomed Engineering B.V. · Disposable Subdermal Needle Electrode 14x0.38mm 2.5m parallel wire 12pairs · 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 08720791374877), received between Apr 1, 2026 and Apr 1, 2026 — 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
- Burn(s)1
- 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 1, 2026Break
TECHNOMED RECEIVED COMPLAINT VIA DISTRIBUTOR CADWELL 10 MARCH 2026 WITH REGARDS TO THE SUBDERMAL NEEDLE PART NUMBER: 302875-000 (NEEDLE, PARALLEL,14X0.38MM (27G) 100IN12PR), EITHER LOT: 103210: THE COMPLAINT IS THAT THE NEEDLE BROKE OFF IN THE PATIENT, REQUIRING AN ADDITIONAL PROCEDURE TO REMOVE IT. THE EVENT DATE WAS TODAY, MARCH 10TH. "WHILE REMOVING NEEDLES AT THE END OF THE CASE, I NOTICED ONE SHARP HAD BROKEN OFF ABOVE THE HUB FROM THE LEFT VL MUSCLE. I CHECKED THE TAPE AND SURROUNDING AREA BUT COULD NOT FIND THE SHARP. I IMMEDIATELY NOTIFIED THE RN AND RESIDENT WHO WAS STILL IN THE ROOM. WE BOTH FELT AROUND THE INSERTION AREA (WHICH ALSO SHOWED TWO BURN MARKS); NEITHER OF US COULD FEEL THE NEEDLE AND WE WERE NOT CERTAIN IT WAS IN THERE. I SUGGESTED WE ASK (B)(6) TO COME BACK IN THE ROOM TO CONFIRM THE SHARP WAS NO LONGER IN THE PATIENT. THE RESIDENT AGREED. FLAT PLATE IMAGES WERE TAKEN AND THE BROKEN SHARP WAS LOCATED. DR. (B)(6) CAME BACK INTO THE OPERATING ROOM AND PERFORMED ANOTHER PROCEDURE TO REMOVED THE SHARP. THIS ENDED UP IN AN ADDITIONAL HOUR OF OPERATING ROOM TIME, ADDITIONAL (B)(6) TIME, ADDITIONAL LOCAL ANESTHETIC, SILVER NITRATE MATCHSTICKS FOR HEMOSTASIS AND TWO
Patient problems: Burn(s); Foreign Body In Patient
MAUDE report 24752006 ↗
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- Rhythmlink® RLSND121-2.5Rhythmlink International, LLC · Electrode, Needle5 reports
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- Rhythmlink® RLSP503Rhythmlink International, LLC · Electrode, Needle3 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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