Red Dot™ 2670-5Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10707387499966), received between Dec 5, 2018 and Apr 10, 2026 — classified as 1 death, 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryApr 10, 2026

  A PATIENT PRESENTED FOR A PORTA CATH PLACEMENT (AIRWAY TYPE USED: LARYNGEAL MASK #5). SEVERAL HOURS POST DISCHARGE, PATIENT EXPERIENCED EXCRUCIATING THROAT PAIN & SOUGHT IMMEDIATE MEDICAL ADVICE FOLLOWED BY MEDICAL ATTENTION ON MULTIPLE OCCASIONS. PATIENT ARRIVED AT AN OUTSIDE FACILITY, ED TO OR FOR DIRECT LARYNGOSCOPY W/ [WITH] REMOVAL OF RETAINED LARYNGEAL FOREIGN BODY WHERE A TRANSLUCENT SHEET OF UNKNOWN MATERIAL, 4.0 X 3.5 CM BY LESS THAN 0.1 CM, CORRELATING W/ BACKING OF ELECTRODE USED IN PROCEDURAL AREAS WAS REMOVED JUST ABOVE TRUE VOCAL FOLDS, LODGED AGAINST ARYTENOIDS. PATIENT REPORTED IMMEDIATE IMPROVEMENT IN SYMPTOMS AND DISCHARGED IN STABLE CONDITION. A TRANSLUCENT FOREIGN OBJECT ENTERED THE INTUBATION/SURGICAL FIELD AND WENT UNNOTICED BY THE SURGICAL TEAM BECAUSE IT WAS DIFFICULT TO VISUALLY DETECT. THIS OCCURRED IN PART BECAUSE THE MANUFACTURERS DID NOT EVALUATE VISIBILITY RISKS OF CLEAR MATERIALS WITH NO MARKING.

  Patient problems: Foreign Body In Patient; Sore Throat

  MAUDE report 24839153 ↗
• InjuryFeb 1, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HOSPITAL IMAGING MANAGER ALLEGED THREE 2670-5 3M¿ RED DOT¿ SOFT CLOTH MONITORING ELECTRODES WERE APPLIED TO A PATIENT IN THE EMERGENCY ROOM. A FEW HOURS FOLLOWING APPLICATION OF THE ELECTRODES, THE PATIENT WAS TRANSFERRED TO THE IMAGING AREA FOR AN MRI PROCEDURE. THE PATIENT DID NOT HAVE CARDIAC MONITORING DURING THE MRI, BUT THE ELECTRODES WERE REPORTEDLY LEFT ON HIS SKIN. THE PATIENT STATED HE FELT PAIN UNDER THE ELECTRODES DURING THE MRI BUT DID NOT SAY ANYTHING UNTIL THE TEST WAS COMPLETED. THE PATIENT ALLEGEDLY EXPERIENCED CIRCULAR BURNS UNDER THE ELECTRODE STUBS. HE WAS SEEN BY A PHYSICIAN IN THE ER AND WAS TREATED WITH RX SILVADENE CREAM.

  Patient problems: Burn(s)

  MAUDE report 8297707 ↗
• DeathDec 13, 2018Device-Device Incompatibility; Device-Device Incompatibility

  A NURSE REPORTED A PATIENT IN ICU EXPERIENCED A SLIGHT DELAY WITH AN URGENT CARDIOVERSION WHEN 2670-5 RED DOT ELECTRODE STUBS WERE FOUND STUCK IN THE DEFIBRILLATOR LEAD WIRES FROM A PREVIOUS USE. THE SLIGHT DELAY OCCURRED WHEN THE STAFF OBTAINED ANOTHER DEFIBRILLATOR FROM THE UNIT FOR THE CARDIOVERSION. THE PATIENT IN THIS REPORT LATER EXPIRED. NO INFORMATION WAS PROVIDED RELATED TO THE PATIENT'S MEDICAL CONDITION/DIAGNOSIS, TIME OF THE INCIDENT OR TIME OF THE PATIENT DEATH. THE NURSE REPORTED THERE WAS NO ASSOCIATION OR FINDINGS THAT THE PATIENT DEATH WAS RELATED TO THIS EVENT.

  Patient problems: Death

  MAUDE report 8160628 ↗
• MalfunctionDec 5, 2018Physical Resistance/Sticking

  A PATIENT IN THE ICU WAS BEING PREPARED FOR SYNCHRONIZED CARDIOVERSION USING DEFIBRILLATION ON THE UNIT AND THERE WAS A DELAY DUE TO 3M RED DOTS BEING STUCK IN THE DEFIBRILLATOR LEADS. IT APPEARED AS THOUGH THE CONNECTORS HAD RIPPED OFF THE STICKY PART OF THE RED DOTS MAKING IT DIFFICULT TO ATTACH NEW RED DOTS. THE OLD ONES HAD TO BE REMOVED USING KELLY CLAMPS.

  Patient problems: No Information

  MAUDE report 8132586 ↗