NOVAPLUS V11460-010 (UDI 10192253061468)Recalls & reported problems

Summary

The FDA's MAUDE database contains 38 adverse event reports that list this exact device (DI 10192253061468), received between Mar 15, 2023 and Mar 25, 2026 — classified as 38 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (36 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 25 most recent of 38 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 25, 2026

  INSTANT INFANT HEEL WARMER PACKET - WENT COLD RATHER THAN WARM WHEN ACTIVATED PER INSTRUCTIONS.

  Patient problems: Insufficient Information

  MAUDE report 24689201 ↗
• MalfunctionJun 20, 2024

  REGISTERED NURSE (RN) ACTIVATED THE HEEL WARMER AS USUAL AND PLACED IT ON INFANT¿S HEEL. NURSE BEGAN ASSESSMENT AND MID ASSESSMENT (~2 MINUTES), THE HEEL WARMER POPPED/EXPLODED AND THE CONTENTS SPLATTED AGAINST INSIDE OF ISOLETTE- ON BLANKETS, WALL OF ISOLETTE AND OUT OF PORTHOLE DOOR ONTO FLOOR. SEAM POPPED OPEN, CONTENTS OF PACKAGE WENT ON INFANT¿S BILATERAL LOWER LEGS, BELOW THE KNEES, AND BEDDING CHANGED. HEEL WARMER PROMPTLY REMOVED AND INFANT CLEANED OF CONTENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19574436 ↗
• MalfunctionJun 30, 2023Burst Container or Vessel; Burst Container or Vessel

  IT HAS BEEN REPORTED THAT WHEN A NURSE ATTEMPTED TO ACTIVATE A HOT PACK USING NORMAL PRESSURE THE PACK CAME APART. THE BROKEN SIDE WAS FACING UPWARDS AND AS IT BROKE IT BURST FORTH ITS CONTENTS SPRAYING ONTO THE NURSE AND ACROSS TWO OCCUPIED BASSINETS. SOME OF THE CONTENTS SPLASHED ONTO THE NURSES HANDS AND ON HER CHEST. THE CONTENTS WERE IMMEDIATELY CLEANED UP WITHOUT ANY INTERACTION. NURSE IS UNAFFECTED BY THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17243373 ↗
• MalfunctionJun 30, 2023Burst Container or Vessel; Burst Container or Vessel

  IT HAS BEEN REPORTED THAT WHEN A NURSE ATTEMPTED TO ACTIVATE A HOT PACK USING NORMAL PRESSURE THE PACK CAME APART. THE BROKEN SIDE WAS FACING UPWARDS AND AS IT BROKE IT BURST FORTH ITS CONTENTS SPRAYING ONTO THE NURSE AND ACROSS TWO OCCUPIED BASSINETS. THE CONTENTS LANDED ON THE BABY¿S SWADDLE AND WAS IMMEDIATELY CLEANED BY OTHER STAFF. THE INFANT IS DOING FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17239159 ↗
• MalfunctionJun 30, 2023Burst Container or Vessel; Burst Container or Vessel

  IT HAS BEEN REPORTED THAT WHEN A NURSE ATTEMPTED TO ACTIVATE A HOT PACK USING NORMAL PRESSURE THE PACK CAME APART. THE BROKEN SIDE WAS FACING UPWARDS AND AS IT BROKE IT BURST FORTH ITS CONTENTS SPRAYING ONTO THE NURSE AND ACROSS TWO OCCUPIED BASSINETS. THE CONTENTS LANDED ON THE BABY¿S SWADDLE AND WAS IMMEDIATELY CLEANED BY OTHER STAFF. THE INFANT IS DOING FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17239126 ↗
• MalfunctionJun 15, 2023Burst Container or Vessel; Burst Container or Vessel

  CUSTOMER REPORTED THAT THE CLINICIAN POPPED THE HEEL WARMER LIKE NORMAL, NO EXTRA FORCE, NEAR THE BEDSIDE IN TRIAGE. IT EXPLODED TOWARDS THE FOOT OF THE BED AT PATIENT'S SHOULDER WITH GEL GETTING ON HIS JACKET. IT ALSO GOT ON CLINICIAN'S SCRUBS, ON PATIENT BED, AND ON THE FLOOR. THERE WAS NO ADVERSE EFFECT. EVENT DATE IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17140014 ↗
• MalfunctionJun 5, 2023Burst Container or Vessel; Burst Container or Vessel

  DURING A VIRTUAL IN-SERVICE WITH THE TEAM AT LA GENERAL MED CENTER, THE CUSTOMER IS REPORTING THAT THEY HAD INFANT HEEL WARMERS BURST WHILE ATTEMPTING TO ACTIVATE THEM. NO ONE WAS INJURED AS THESE WERE CONTROLLED TESTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17066329 ↗
• MalfunctionJun 5, 2023Burst Container or Vessel; Burst Container or Vessel

  DURING A VIRTUAL IN-SERVICE WITH THE TEAM AT (B)(6) CENTER, THE CUSTOMER IS REPORTING THAT THEY HAD INFANT HEEL WARMERS BURST WHILE ATTEMPTING TO ACTIVATE THEM. PACK CONTENTS LANDED ON NURSES RIGHT ARM, HAND AND FACE. SHE USED SOAP AND WATER TO CLEAN AND REMOVE CONTENTS AND NO OTHER MEDICATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17065525 ↗
• MalfunctionJun 5, 2023Burst Container or Vessel; Burst Container or Vessel

  DURING A VIRTUAL IN-SERVICE WITH THE TEAM AT (B)(6), THE CUSTOMER IS REPORTING THAT THEY HAD INFANT HEEL WARMERS BURST WHILE ATTEMPTING TO ACTIVATE THEM. NO ONE WAS INJURED AS THESE WERE CONTROLLED TESTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17063388 ↗
• MalfunctionJun 5, 2023Burst Container or Vessel; Burst Container or Vessel

  DURING A VIRTUAL IN-SERVICE WITH THE TEAM AT LA GENERAL MED CENTER, THE CUSTOMER IS REPORTING THAT THEY HAD INFANT HEEL WARMERS BURST WHILE ATTEMPTING TO ACTIVATE THEM. NO ONE WAS INJURED AS THESE WERE CONTROLLED TESTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17062141 ↗
• MalfunctionMay 27, 2023Burst Container or Vessel; Burst Container or Vessel

  CUSTOMER REPORTED THE NOVA PLUS HEEL WARMER BURST THROUGH THE PACKAGING WHEN ACTIVATED. THE LIQUID GEL DEBRIS FROM HEEL WARMER PACK SPLATTERED ON INFANT PATIENT. THE DEBRIS WAS WIPED OFF THE INFANT AND THE HEAL WARMER WAS DISCARDED. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17015413 ↗
• MalfunctionMay 27, 2023Burst Container or Vessel; Burst Container or Vessel

  CUSTOMER REPORTED THE NOVA PLUS HEEL WARMER BURST THROUGH THE PACKAGING WHEN ACTIVATED. THE LIQUID GEL DEBRIS FROM HEEL WARMER PACK SPLATTERED ON STAFF MEMBER. THE DEBRIS WAS WIPED OFF THE STAFF MEMBER AND THE HEAL WARMER WAS DISCARDED. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17015412 ↗
• MalfunctionMay 12, 2023Burst Container or Vessel; Burst Container or Vessel

  MEDWATCH MW5116504 STATED THE CUSTOMER REPORTED THAT THEY HAVE HAD SEVERAL INSTANCES OF THE NOVAPLUS INFANT HEEL WARMER EXPLODING WHEN SQUEEZING FOR ACTIVATION, WHICH CAN RESULT IN INJURY TO STAFF AND/OR PATIENTS. IT IS UNCLEAR AT THIS TIME IF THIS IS ISOLATED TO A SPECIFIC LOT NUMBER. CUSTOMER DID NOT PROVIDE ANY FURTHER INFORMATION UPON REQUEST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16924741 ↗
• MalfunctionMay 2, 2023Burst Container or Vessel; Burst Container or Vessel

  CUSTOMER REPORTED THAT WHEN STAFF TRIED TO ACTIVATE THE HEAL WARMER FOR A PATIENT, THE HEAL WARMER BURST. IT'S REPORTED THAT IT WAS ALREADY UNDER PRESSURE FROM IT ALREADY BEING ACTIVATED WHICH CAUSED THE HEAL WARMER TO BURST. THERE WAS NO INJURY OR ADVERSE EFFECT CAUSED BY THE HOT PACK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16854166 ↗
• MalfunctionMay 1, 2023Burst Container or Vessel; Burst Container or Vessel

  CUSTOMER REPORTED THAT WHEN STAFF TRIED TO ACTIVATE THE HEAL WARMER FOR A PATIENT, THE HEAL WARMER BURST. IT'S REPORTED THAT IT WAS ALREADY UNDER PRESSURE FROM IT ALREADY BEING ACTIVATED WHICH CAUSED THE HEAL WARMER TO BURST. THERE WAS NO INJURY OR ADVERSE EFFECT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16849808 ↗
• MalfunctionMay 1, 2023Burst Container or Vessel; Burst Container or Vessel

  CUSTOMER REPORTED THAT WHEN STAFF TRIED TO ACTIVATE THE HEAL WARMER FOR A PATIENT, THE HEAL WARMER BURST. IT'S REPORTED THAT IT WAS ALREADY UNDER PRESSURE FROM IT ALREADY BEING ACTIVATED WHICH CAUSED THE HEAL WARMER TO BURST. THERE WAS NO INJURY OR ADVERSE EFFECT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16849799 ↗
• MalfunctionMay 1, 2023Burst Container or Vessel; Burst Container or Vessel

  CUSTOMER REPORTED THAT THE HEAL WARMER BURST WHEN THE PHLEBOTOMIST ATTEMPTED TO USE IT. THERE WAS NO INJURY OR ADVERSE EFFECT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16849778 ↗
• MalfunctionMay 1, 2023Burst Container or Vessel; Burst Container or Vessel

  CUSTOMER REPORTED THAT THE HEAL WARMER BURST WHEN THE PHLEBOTOMIST ATTEMPTED TO USE IT. THERE WAS NO INJURY OR ADVERSE EFFECT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16849735 ↗
• MalfunctionMay 1, 2023Burst Container or Vessel; Leak/Splash; Burst Container or Vessel; Leak/Splash

  MEDWATCH REPORT STATES THE NOVAPLUS INFANT HEEL WARMER PACKETS (TEAL/WHITE PACKAGING) IS "EXPLODING" WHEN ACTIVATED. WHEN SQUEEZED TO ACTIVATE THE CONTENTS, THE SEAL ON THE PACKAGING OPENS UP AND THE CONTENTS SPRAY ACROSS THE AREA. ONE STAFF HAS MADE CONTACT WITH HER SKIN AND CAUSED SOME IRRITATION. DEFECTIVE ITEM DID NOT REACH THE BABY. NO CUSTOMER CONTACT INFORMATION PROVIDED.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 16849628 ↗
• MalfunctionMay 1, 2023Burst Container or Vessel; Burst Container or Vessel

  CUSTOMER REPORTED THE INFANT HEEL WARMER RUPTURE/EXPLODED WHILE ACTIVATING AND THE CONTENTS WENT EVERYWHERE. ONE NURSE GOT IT IN HER EYES CAUSING BURNING AND HAD TO USE THE EYE WASH STATION TO RINSE OUT HER EYES. NO INJURY OR MEDICATION PROVIDED, AND THE NURSE IS DOING WELL. NO DEMOGRAPHICS PROVIDED.

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

  MAUDE report 16845834 ↗
• MalfunctionApr 30, 2023Burst Container or Vessel; Burst Container or Vessel

  CUSTOMER REPORTED I ACTIVATED ANOTHER HEEL WARMER WITH THE SAME LOT NUMBER AS THE TWO THAT BURST EARLIER IN THE SHIFT. THIS HEEL WARMER WAS ACTIVE TOWARD THE GROUND WITHOUT A LOT OF FORCE AND IT BURST AND THE CONTENTS LANDED ON THE FLOOR. HAD I SQUEEZED HARDER THE WARMER WOULD HAD EXPLODED WITH A LOT MORE FORCE. NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16841291 ↗
• MalfunctionApr 30, 2023Burst Container or Vessel; Burst Container or Vessel

  CUSTOMER REPORTED NURSE ACTIVATED A HEEL WARMER AND IT BURST IN HER HAND AND THE CONTENTS CAME IN CONTACT WITH HER UNIFORM, FACE, AND EYES. SHE FLUSHED HER EYES WITH WATER AS WE DON¿T HAVE AN ¿EYE WASH STATION¿ IN THE NURSERY OR ON THE THIRD FLOOR. THE NURSE WAS TAKEN TO THE EMERGENCY ROOM AND TREATED. HER EYES WERE REDDENED AND SWOLLEN. THERE WAS IRRIGATION TO THE EYE(S) NOTED FROM A PICTURE, HOWEVER THE EXTENT OF TREATMENT IS NOT KNOWN SINCE IT WAS DONE IN ED. SHE WAS TAKEN OFF OF WORK AND HAS AN OPHTHALMOLOGIST APPOINTMENT FOR FOLLOW UP CARE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16841290 ↗
• MalfunctionApr 30, 2023Burst Container or Vessel; Burst Container or Vessel

  CUSTOMER REPORTED NURSE ACTIVATED NOVAPLUS+ INFANT HEEL WARMER AS USUAL AND THE WARMER OPENED AND THE CONTENT MADE CONTACT WITH HER TEE SHIRT. NURSE STATED SHE DID NOT FEEL ANY SPLASH ONTO HER FACE BUT AS A PRECAUTION I SUGGESTED SHE RINSE HER EYES WITH NORMAL SALINE/WATER SINCE SOME CONTENTS CAME IN CONTACT WITH HER EYE BROW. NO OTHER DEMOGRAPHICS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16841289 ↗
• MalfunctionApr 26, 2023Burst Container or Vessel; Burst Container or Vessel

  CUSTOMER REPORTED NURSE WAS SQUEEZING TO ACTIVE THE HEEL WARMER WHEN THE BAG EXPLODED INTO HER FACE, HAIR, CHEST, AND ABDOMEN. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16812632 ↗
• MalfunctionApr 21, 2023Burst Container or Vessel; Burst Container or Vessel

  CUSTOMER REPORTED THAT PRODUCT FROM A BURST HOT PACK LANDED ON BABY'S FOREHEAD AFTER ACTIVATING TO PERFORM HEEL STICK. THE DEMOGRAPHICS FOR THE BABY ARE UNKNOWN. NO INJURY TO BABY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16792042 ↗