NOVAPLUS V11460-010 (UDI 10885380057588)Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10885380057588), received between Apr 4, 2022 and Oct 19, 2023 — classified as 16 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (15 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Jun 16, 2023Open, Classified

   Cardinal Health has received an increase in burst/leaking complaints from mid-April to May regarding the above listed lot of the Novalplus Infant Heel Warmer with tape.

   Z-2147-2023 · Root cause: Process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 19, 2023Burst Container or Vessel; Burst Container or Vessel

  CUSTOMER REPORTED THE HOT PACK EXPLODED WHILE NURSE WAS PERFORMING TEST ON NEWBORN. THE CONTENTS DID NOT COME INTO CONTACT WITH NEWBORN OR NURSE'S SKIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17965776 ↗
• MalfunctionAug 10, 2023Burst Container or Vessel; Burst Container or Vessel

  MEDWATCH REPORT (B)(4) STATED A PHLEBOTOMY TECHNICIAN ATTEMPTED TO ACTIVATE HEEL WARMER TO USE ON A PATIENT WITH DIFFICULT VENOUS ACCESS IN LATE AFTERNOON. TECH SQUEEZED THE PACK TO ACTIVATE, AND THE PACK BURST AND LEAKED ALL OVER THE PATIENT'S BED. TECH STATES THAT THE PATIENT WAS NOT INJURED, AND HE CLEANED UP THE CONTENTS OFF THE BED. TECH WAS NOT AFFECTED BY THE LEAKED PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17497579 ↗
• MalfunctionAug 8, 2023Burst Container or Vessel; Burst Container or Vessel

  CUSTOMER REPORTED THAT THE INFANT HEEL WARMER EXPLODED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17484602 ↗
• MalfunctionJul 18, 2023Burst Container or Vessel; Burst Container or Vessel

  IT HAS BEEN REPORTED THAT A NOVAPLUS HEEL WARMER BURST ON A STAFF MEMBER AT THEIR HOSPITAL. THERE WAS NO INJURY OR ADVERSE EFFECT, AND NO MEDICATION WAS PROVIDED TO STAFF MEMBER DUE TO THE HEEL WARMER BURSTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17346730 ↗
• MalfunctionJun 20, 2023Burst Container or Vessel; Burst Container or Vessel

  CUSTOMER REPORTED NURSE USED THE INFANT HEEL WARMER AND THE PACK POPPED OPEN WHILE ACTIVATING AND LIQUID FLEW EVERYWHERE. THE NURSE WAS NOT NEAR A PATIENT OR VISITOR AND DID NOT GET THE CONTENTS ON HERSELF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17162858 ↗
• MalfunctionJun 20, 2023Burst Container or Vessel; Burst Container or Vessel

  CUSTOMER REPORTED NURSE USED THE INFANT HEEL WARMER AND THE PACK POPPED OPEN WHILE ACTIVATING AND LIQUID FLEW EVERYWHERE. THE NURSE WAS NOT NEAR A PATIENT OR VISITOR AND DID NOT GET THE CONTENTS ON HERSELF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17162743 ↗
• MalfunctionJun 19, 2023Burst Container or Vessel; Burst Container or Vessel

  CUSTOMER REPORTED THAT THE INFANT HEEL WARMERS HAVE MALFUNCTIONED. WHEN YOU SQUEEZE THEM TO ACTIVATE, THEY BREAK OPEN. YESTERDAY THE MOTHER WAS SITTING CLOSE TO THE NURSE WHEN THIS HAPPENED AND IT SPRAYED ALL OVER HER FACE AND IN HER EYES. MOTHER USED THE EYE WASH STATION. THERE WAS NO INJURY OR MEDICAL CARE REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17159554 ↗
• MalfunctionOct 11, 2022Material Frayed; Material Frayed

  CUSTOMER REPORTED, AS I SQUEEZED THE INFANT HEAL WARMER, THE CONTENTS SPEWED OUT LANDING MOSTLY ON MY ARM, BUT SOME LANDED ON THE BED TO THE LEFT OF THE INFANT. I HAD ON A LONG SLEEVE SCRUB JACKET THAT I IMMEDIATELY TOOK OFF. I ALSO REMOVED THE AFFECTED LINENS FROM THE BED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15578423 ↗
• MalfunctionJun 13, 2022Burst Container or Vessel; Burst Container or Vessel

  CUSTOMER REPORT THAT WHEN ACTIVATING THE INFANT HEEL WARMER AS INSTRUCTED, IT BURST, AND CONTENTS WENT ACROSS THE ROOM HITTING STAFF MEMBER. THE STAFF MEMBER WAS WEARING GLOVES, THEREFORE NO SKIN EXPOSURE OR ADVERSE EVENT TO STAFF OR PATIENT. NO DEMOGRAPHIC OR OTHER INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14681664 ↗
• MalfunctionJun 13, 2022Burst Container or Vessel; Burst Container or Vessel

  CUSTOMER REPORT THAT WHEN ACTIVATING THE INFANT HEEL WARMER AS INSTRUCTED, IT BURST, AND CONTENTS WENT ACROSS THE ROOM HITTING STAFF MEMBER. THE STAFF MEMBER WAS WEARING GLOVES, THEREFORE NO SKIN EXPOSURE OR ADVERSE EVENT TO STAFF OR PATIENT. NO DEMOGRAPHIC OR OTHER INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14681622 ↗
• MalfunctionJun 13, 2022Burst Container or Vessel; Burst Container or Vessel

  CUSTOMER REPORT THAT WHEN ACTIVATING THE INFANT HEEL WARMER AS INSTRUCTED, IT BURST, AND CONTENTS WENT ACROSS THE ROOM HITTING STAFF MEMBER. THE STAFF MEMBER WAS WEARING GLOVES, THEREFORE NO SKIN EXPOSURE OR ADVERSE EVENT TO STAFF OR PATIENT. NO DEMOGRAPHIC OR OTHER INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14680776 ↗
• MalfunctionJun 13, 2022Burst Container or Vessel; Burst Container or Vessel

  CUSTOMER REPORT THAT WHEN ACTIVATING THE INFANT HEEL WARMER AS INSTRUCTED, IT BURST, AND CONTENTS WENT ACROSS THE ROOM HITTING STAFF MEMBER. THE STAFF MEMBER WAS WEARING GLOVES, THEREFORE NO SKIN EXPOSURE OR ADVERSE EVENT TO STAFF OR PATIENT. NO DEMOGRAPHIC OR OTHER INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14678682 ↗
• MalfunctionJun 13, 2022Burst Container or Vessel; Burst Container or Vessel

  CUSTOMER REPORT THAT WHEN ACTIVATING THE INFANT HEEL WARMER AS INSTRUCTED, IT BURST, AND CONTENTS WENT ACROSS THE ROOM HITTING STAFF MEMBER. THE STAFF MEMBER WAS WEARING GLOVES, THEREFORE NO SKIN EXPOSURE OR ADVERSE EVENT TO STAFF OR PATIENT. NO DEMOGRAPHIC OR OTHER INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14678267 ↗
• MalfunctionJun 3, 2022Burst Container or Vessel; Burst Container or Vessel

  CUSTOMER REPORTED THAT WHEN ACTIVATING THE INFANT HEEL WARMER AS INSTRUCTED, IT BURST AND CONTENTS WENT ACROSS THE ROOM HITTING STAFF MEMBER¿S JACKET. THERE WAS NO SKIN EXPOSURE OR ADVERSE EVENT. EVENT DATE IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14598381 ↗
• MalfunctionMay 20, 2022Burst Container or Vessel; Burst Container or Vessel

  NURSES DESCRIBED THAT WHEN THEY SQUEEZE TO ACTIVATE THE PRODUCT, THE POUCH WOULD RUPTURE, AND THE CONTENTS WOULD SPILL OUT. CUSTOMER REPORTED THAT DURING ACTIVATION, THE INFANT HEEL WARMER RUPTURED ONTO NURSE¿S 2ND AND 3RD DIGIT ON LEFT HAND CAUSING ERYTHEMA AND NUMBNESS. HANDS WERE WASHED WITH SOAP AND WATER. NO FURTHER FOLLOW UP CARE WAS REQUIRED. NURSE REPORTED CURRENTLY THE AFFECTED AREA HAS OCCASIONAL TINGLING AFTER 2 WEEKS. ACTUAL EVENT DATE IS UNKNOWN BY CUSTOMER.

  Patient problems: Erythema

  MAUDE report 14458849 ↗
• MalfunctionApr 4, 2022Burst Container or Vessel; Burst Container or Vessel

  CUSTOMER REPORTED THAT THE HEEL WARMER EXPLODED ON A NURSE IN THE NICU WHEN SHE SQUEEZED IT TO ACTIVATE IT. THERE WAS NO INJURY OR FOLLOW UP CARE REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14000046 ↗