Accurian AC0010Recalls & reported problems
Medtronic Sofamor Danek, Inc. · CANNULA AC0010 100MM 20G 10MM SS · Class 2
Data updated Oct 16, 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 20763000153582), received between Apr 29, 2026 and Jun 29, 2026 — classified as 2 malfunctions.
6 other recalls cover devices cleared under the same FDA submission (K181864); they may or may not involve this specific model.
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
Patient problems
- Cramp(s) /Muscle Spasm(s)1
- Electric Shock1
- Neck Pain1
- Undesired Nerve Stimulation1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 29, 2026
ACCORDING TO THE PHYSICIAN THIS HAS BEEN REPORTED BEFORE. UNPROMPTED PULSATION (ELECTRICAL CURRENT) FROM RFA MACHINE TO PATIENT THROUGH NEEDLE CANNULAS.
Patient problems: Electric Shock
MAUDE report 25650462 ↗MalfunctionApr 29, 2026
AFTER DOING ONE SENSORY TEST AND THEN TURNING OFF SENSORY STIMULI, THERE REMAINED A PULSATING STIMULI THAT WAS OBSERVED WITH QUIVERING OF THE PATIENT'S POSTERIOR NECK MUSCULATURE. PATIENT ALSO ENDORSED FEELING THE HIGH-FREQUENCY PULSATION. FROM HAVING EXPERIENCE WITH THIS UNFORTUNATELY HAPPENING ON RARE OCCURRENCE PREVIOUSLY, I HAD CONCERNED THAT THE MEDTRONIC NEEDLES MAY HAVE BAH SOME FORM OF A DEFECT. WE INITIALLY REPLACED THE PROBES TO SEE IF THIS WOULD CORRECT THE ISSUE, WHICH IT DID NOT. AT THAT TIME, AGAIN BEING FAMILIAR WITH THE SITUATION FROM A HANDFUL OF TIMES OVER SEVERAL YEARS, THE NEEDLE CANNULAS WERE REMOVED. NEW NEEDLES WERE THEN USED. SENSORY AND MOTOR TESTING WAS THEN CONDUCTED WITHOUT ANY FURTHER TECHNICAL ISSUES SUCH AS PREVIOUSLY SEEN AND DESCRIBED ABOVE. - STATED BY PHYSICIAN [REDACTED].
Patient problems: Cramp(s) /Muscle Spasm(s); Neck Pain; Undesired Nerve Stimulation
MAUDE report 25027904 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K181864. One submission often covers many models, so check the product and lot details in each record.
- Z-2693-2020 · Jun 8, 2020 · TerminatedAccurian RF Ablation, Cannula pk, Accurian, 150mm, 20G, 10mm, CS Product Number: AC0012 GTIN / UPN: 20763000153629 - Product Usage: (sterile, single-use) comprises an electrically
- Z-2692-2020 · Jun 8, 2020 · TerminatedAccurian RF Ablation, Cannula pk, Accurian, 100mm, 20G, 10mm, CS Product Number: AC0009 GTIN / UPN: 20763000153599 - Product Usage: (sterile, single-use) comprises an electrically
- Z-2690-2020 · Jun 8, 2020 · TerminatedAccurian RF Ablation, Cannula pk, Accurian, 100mm, 18G, 10mm, CS Product Number: AC0005 GTIN /UPN: 20763000153551 - Product Usage: (sterile, single-use) comprises an electrically i
- Z-2694-2020 · Jun 8, 2020 · TerminatedAccurian RF Ablation, Cannula pk, Accurian, 100mm, 22G, 5mm, CS Product Number: AC0016 GTIN / UPN: 20763000153674 - Product Usage: (sterile, single-use) comprises an electrically i
- Z-2691-2020 · Jun 8, 2020 · TerminatedAccurian RF Ablation, Cannula pk, Accurian, 150mm, 18G, 10mm, CS Product Number: AC0007 GTIN / UPN: 20763000153568 - Product Usage: (sterile, single-use) comprises an electrically
- Z-2695-2020 · Jun 8, 2020 · TerminatedAccurian RF Ablation,Cannula pk, Accurian, 100mm, 22G, 10mm, SS Product Number: AC0019 GTIN / UPN: 20763000153667 - Product Usage: (sterile, single-use) comprises an electrically
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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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