Premier 1006065Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI D6911006065), received between Dec 23, 2021 and Dec 23, 2021 — classified as 3 injuries.

The most frequently reported specific device problem is “Fluid/Blood Leak” (3 reports).

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.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryDec 23, 2021Fluid/Blood Leak; Gas Output Problem; Material Twisted/Bent; Device Handling Problem; Fluid/Blood Leak; Gas Output Problem; Material Twisted/Bent; Device Handling Problem

  PRIOR TO CONTACTING THE MANUFACTURER ON (B)(6) 2021, (B)(6) USED NITROSPRAY PLUS LITE TO TREAT A PATIENT. PER THE EMAIL NOTIFICATION FROM THE ASSOCIATE CLINICAL DIRECTOR: "WE USE DIFFERENT BORE NEEDLES (SPRAY TIPS) TO USE FOR CRYOTHERAPY & HAVE EXPERIENCED 4 SEPARATE INCIDENCES OF CHEMICAL BURNS (BLISTERING) AFTER TREATMENT". THE PHYSICIAN IS TRYING TO UNDERSTAND WHY THIS HAS HAPPENED OVER THE PAST MONTH. SHE QUESTIONED THE SPRAY TIP SIZES & HAD CONTACTED THEIR GAS PROVIDER AS WELL. THE BURNS WERE NOT SERIOUS, ONE WAS DEEPER THAN THE OTHERS. SHE HAS BEEN ADVISED TO SEND THE THREE UNITS IN FOR EVALUATION ALONG WITH SPRAY TIPS THAT HAVE BEEN USED. THIS REPORT IS FOR PATIENT 1 OUT OF 3.

  Patient problems: Cryogenic Burn

  MAUDE report 13078677 ↗
• InjuryDec 23, 2021Fluid/Blood Leak; Gas Output Problem; Material Twisted/Bent; Fluid/Blood Leak; Gas Output Problem; Material Twisted/Bent

  PRIOR TO CONTACTING THE MANUFACTURER ON (B)(6) 2021, (B)(6) CENTER FOR FAMILY AND COMMUNITY MEDICINE USED NITROSPRAY PLUS LITE TO TREAT A PATIENT. PER THE EMAIL NOTIFICATION FROM THE ASSOCIATE CLINICAL DIRECTOR: "WE USE DIFFERENT BORE NEEDLES (SPRAY TIPS) TO USE FOR CRYOTHERAPY & HAVE EXPERIENCED 4 SEPARATE INCIDENCES OF CHEMICAL BURNS (BLISTERING) AFTER TREATMENT". THE PHYSICIAN IS TRYING TO UNDERSTAND WHY THIS HAS HAPPENED OVER THE PAST MONTH. SHE QUESTIONED THE SPRAY TIP SIZES & HAD CONTACTED THEIR GAS PROVIDER AS WELL. THE BURS WERE NOT SERIOUS, ONE WAS DEEPER THAN THE OTHERS. SHE HAS BEEN ADVISED TO SEND THE THREE UNITS IN FOR EVALUATION ALONG WITH SPRAY TIPS THAT HAVE BEEN USED. THIS REPORT IS FOR PATIENT 2 OUT OF 3.

  Patient problems: Cryogenic Burn

  MAUDE report 13078667 ↗
• InjuryDec 23, 2021Fluid/Blood Leak; Gas Output Problem; Material Twisted/Bent; Device Handling Problem; Fluid/Blood Leak; Gas Output Problem; Material Twisted/Bent; Device Handling Problem

  PRIOR TO CONTACTING THE MANUFACTURER ON (B)(6) 2021, (B)(6) CENTER FOR FAMILY AND COMMUNITY MEDICINE USED NITROSPRAY PLUS LITE TO TREAT A PATIENT. PER THE EMAIL NOTIFICATION FROM THE ASSOCIATE CLINICAL DIRECTOR: "WE USE DIFFERENT BORE NEEDLES (SPRAY TIPS) TO USE FOR CRYOTHERAPY & HAVE EXPERIENCED 4 SEPARATE INCIDENCES OF CHEMICAL BURNS (BLISTERING) AFTER TREATMENT". THE PHYSICIAN IS TRYING TO UNDERSTAND WHY THIS HAS HAPPENED OVER THE PAST MONTH. SHE QUESTIONED THE SPRAY TIP SIZES & HAD CONTACTED THEIR GAS PROVIDER AS WELL. THE BURS WERE NOT SERIOUS, ONE WAS DEEPER THAN THE OTHERS. SHE HAS BEEN ADVISED TO SEND THE THREE UNITS IN FOR EVALUATION ALONG WITH SPRAY TIPS THAT HAVE BEEN USED. THIS REPORT IS FOR PATIENT 1 OUT OF 3.

  Patient problems: Cryogenic Burn

  MAUDE report 13078664 ↗