NOVAPLUS V11450-040B (UDI 10885380167195)Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10885380167195), received between Sep 3, 2021 and Jan 24, 2024 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (10 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 24, 2024Burst Container or Vessel; Burst Container or Vessel

  CUSTOMER STATED, WE HAVE RECENTLY RECEIVED CONCERNS FROM OUR PHLEBOTOMY TEAM REGARDING RUPTURED HOT PACKS. THEY HAVE CONFIRMED PRODUCT TO BE CARDINAL¿S AND HAVE PROVIDED ONE LOT NUMBER SO FAR. THREE STAFF MEMBERS WERE SPLASHED AND HAD TO WASH OFF THEIR CLOTHES, NO HARM JUST DISCOMFORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18576953 ↗
• MalfunctionJan 24, 2024Burst Container or Vessel; Burst Container or Vessel

  CUSTOMER REPORTED, WE HAVE RECENTLY RECEIVED CONCERNS FROM OUR PHLEBOTOMY TEAM REGARDING RUPTURED HOT PACKS. THEY HAVE CONFIRMED PRODUCT TO BE CARDINAL¿S AND HAVE PROVIDED ONE LOT NUMBER SO FAR. THREE STAFF MEMBERS WERE SPLASHED AND HAD TO WASH OFF THEIR CLOTHES, NO HARM JUST DISCOMFORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18576949 ↗
• MalfunctionJan 24, 2024Burst Container or Vessel; Burst Container or Vessel

  CUSTOMER STATED, WE HAVE RECENTLY RECEIVED CONCERNS FROM OUR PHLEBOTOMY TEAM REGARDING RUPTURED HOT PACKS. THEY HAVE CONFIRMED PRODUCT TO BE CARDINAL¿S AND HAVE PROVIDED ONE LOT NUMBER SO FAR. THREE STAFF MEMBERS WERE SPLASHED AND HAD TO WASH OFF THEIR CLOTHES, NO HARM JUST DISCOMFORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18576947 ↗
• MalfunctionMar 2, 2023Burst Container or Vessel; Burst Container or Vessel

  CUSTOMER REPORTED WHEN A CARE ASSISTANT POPPED THE HOT PACK AND PROVIDED IT TO A PATIENT, THE CHEMICALS SPILLED ONTO THE PATIENT'S HANDS. THE HOT PACK HAD A HOLE IN THE PACKAGE, WHICH WAS NOT NOTICED UNTIL THE CHEMICALS SPILLED. THE PATIENT WAS ENCOURAGED TO WASH HIS HANDS. NO HARM WAS NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16474548 ↗
• MalfunctionMar 2, 2023Burst Container or Vessel; Burst Container or Vessel

  CUSTOMER REPORTED MALE PATIENT POPPED THE HOT PACK HIMSELF, AND THE CHEMICALS LEAKED ON HIS SHIRT AND HANDS. PATIENT ENCOURAGED TO WASH HIS HANDS, AND HE WAS PROVIDED A NEW SHIRT. NO HARM WAS NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16474545 ↗
• MalfunctionMar 17, 2022Burst Container or Vessel; Burst Container or Vessel

  CUSTOMER REPORTED THAT THE NURSE ACTIVATED THE HOT PACK BY SQUEEZING AND THE OUTER PACKAGE RUPTURED ALLOWING CONTENTS TO LEAK OUT ONTO HANDS. CONTENTS WAS WASHED OFF WITH SOAP AND WATER. THERE WAS NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13795665 ↗
• MalfunctionMar 17, 2022Burst Container or Vessel; Burst Container or Vessel

  CUSTOMER REPORTED THAT THE NURSE SQUEEZED THE HOT PACK TO ACTIVATE IT AND IT BURST OPEN SPILLING CONTENTS ON HANDS AND ARMS. CONTENTS WAS WASHED OFF WITH SOAP AND WATER. THERE WAS NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13795634 ↗
• MalfunctionMar 16, 2022Burst Container or Vessel; Burst Container or Vessel

  HOT PACK BURST DURING ACTIVATION AND CONTENTS SPLASHED ON THE CLINICIAN¿S CHEST, HANDS, AND FACE. NO INJURY, JUST WASHED WITH SOAP AND WATER. NO DEMOGRAPHICS PROVIDED FOR THE NURSE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13779698 ↗
• MalfunctionMar 15, 2022Burst Container or Vessel; Burst Container or Vessel

  HOT PACK BURST UPON ACTIVATION. THE CONTENTS DID NOT REACH THE PATIENT AND THERE WAS NO INJURY TO CLINICIAN.

  MAUDE report 13765069 ↗
• MalfunctionJan 7, 2022Use of Device Problem; Use of Device Problem

  CUSTOMER REPORTED MEDIUM SIZE HEAT PACK WAS USED OFF LABEL AS AN INFANT HEEL WARMER. REPORTEDLY, THE HEAT PACK CAUSED A FIRST-DEGREE BURN LEAVING RED BLOTCHY PATCHES ON LEFT ARM AND RIGHT LEG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13196773 ↗
• MalfunctionSep 3, 2021Break; Burst Container or Vessel; Fluid/Blood Leak; Burst Container or Vessel

  CUSTOMER REPORTED HOT PACK BURST WHEN ACTIVATING IT FOR A PATIENT. THE BAG BROKE AND SPILT FLUID ON NURSE AND PATIENT BED. THE NURSE WASHED PRODUCT OFF HIS SKIN IMMEDIATELY AFTER AND REPORTEDLY HAD SLIGHT REDNESS; HOWEVER, NO ACTUAL INJURY CONFIRMED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Erythema; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12422388 ↗