NOVAPLUS V11443-012BRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10885380167218), received between Aug 27, 2021 and Aug 18, 2023 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (7 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 18, 2023Burst Container or Vessel; Burst Container or Vessel

  CUSTOMER REPORTED THAT THE HOT PACK EXPLODED ON A NURSE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17578396 ↗
• MalfunctionApr 7, 2023Burst Container or Vessel; Burst Container or Vessel

  THE CUSTOMER HAS REPORT THE ISSUE OF HOT PACKS RUPTURING AND SPILLING THEIR CONTENTS UPON ACTIVATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16704236 ↗
• MalfunctionMar 30, 2023Burst Container or Vessel; Burst Container or Vessel

  COMPLAINT RECEIVED ON MEDWATCH REPORT, (B)(4). CUSTOMER REPORTED THAT WHEN A PATIENT NEEDED A HOT PACK FOR AN IV START, THE RN WENT TO ACTIVATE IT BY SQUEEZING AND IT BURST. THERE WAS NO INJURY TO THE PATIENT. THE GEL LANDED ON THE TEAM MEMBERS SKIN WITHOUT ANY INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16649716 ↗
• MalfunctionMay 4, 2022Burst Container or Vessel; Burst Container or Vessel

  WE HAD ANOTHER PACKAGE OPEN UP AND SPILL ON EMPLOYEE¿S HAND. NO INJURY; HOWEVER, IT DID GET ALL OVER HER HAND AND WAS PRETTY HOT. SHE IMMEDIATELY WASHED THE CONTENTS OFF.

  Patient problems: Skin Burning Sensation

  MAUDE report 14278539 ↗
• MalfunctionApr 20, 2022Burst Container or Vessel; Burst Container or Vessel

  CUSTOMER REPORTED THAT THE RN SQUEEZED A HOT PACK TO ACTIVATE, THE HOT PACK BURST, SPILLING CONTENTS ON HER PANTS, SHOES, AND SCRUB JACKET. THERE WAS NO CONTACT WITH SKIN, NO INJURY OR MEDICAL TREATMENT REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14161326 ↗
• MalfunctionOct 20, 2021Burst Container or Vessel; Burst Container or Vessel

  CUSTOMER REPORTED THROUGH MEDWATCH UF/IMPORTER REPORT # (B)(4) THAT WHEN THE NURSE WAS ACTIVATING THE HOT PACK, IT EXPLODED. THERE WAS NO REPORTED INJURY TO THE NURSE. THE PATIENT WAS NOT IN THE ROOM. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12668732 ↗
• MalfunctionAug 27, 2021Burst Container or Vessel; Burst Container or Vessel

  CUSTOMER REPORTED HOT PACK BURST AND CONTENTS LANDED ON TEAM MEMBER'S HAND AND SLEEVE OF LAB COAT. THE TEAM MEMBER INVOLVED REPORTED THAT THE HOT PACK WAS NOT YET ACTIVATED, BUT TWO TEAM MEMBERS REPORTEDLY HEARD A POPPING SOUND JUST PRIOR TO THE PACK BURSTING. THE TEAM MEMBER EXPERIENCED A BURNING SENSATION. NO MEDICATIONS OR TREATMENT PROVIDED, TEAM MEMBER RINSED CONTENTS OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12380602 ↗