NA CR-10Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00813250012200), received between Oct 2, 2018 and Oct 5, 2018 — classified as 2 injuries.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryOct 5, 2018Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  A REPORT WAS RECEIVED THAT A WEEK FOLLOWING THE RF ABLATION PROCEDURE THE PATIENT DEVELOPED 4 WHEALS OR BUMPS AT THE LOCATION OF THE NEEDLE INSERTION.

  Patient problems: Hypersensitivity/Allergic reaction; Superficial (First Degree) Burn

  MAUDE report 7939801 ↗
• InjuryOct 2, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A REPORT WAS RECEIVED THAT THE PATIENT DEVELOPED TWO WELTS OR BUMPS ON THE SKIN WHERE THE NEEDLES HAD BEEN PLACED. THE PHYSICIAN BELIEVED IT WAS A BURN BUT DID NOT DO DIAGNOSTIC CHECKS TO CONFIRM. THERE WAS NO INTERVENTION TO TREAT THE BURN.

  Patient problems: Superficial (First Degree) Burn

  MAUDE report 7928058 ↗