Argyle MH00002TRecalls & reported problems

Summary

The FDA's MAUDE database contains 53 adverse event reports that list this exact device (DI 30884527004632), received between Jan 9, 2020 and Aug 3, 2022 — classified as 2 injuries, 51 malfunctions.

The most frequently reported specific device problem is “Explosion” (37 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 53 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 3, 2022Temperature Problem; Temperature Problem

  THE CUSTOMER REPORTED THAT THEY HAVE NOT ORDERED THIS PRODUCT SINCE 2020 AND PER THE CLINICAL MANAGER, THEY FOUND A BOX AND ADDED THE PRODUCT TO THEIR SHELF IN THE SUPPLY ROOM. ON ACTIVATION, THE PRODUCT BECAME VERY HOT. THE REPORTER TRIED IT AND IT WAS WAY ABOVE THE EXPECTED TEMPERATURE. THEY DO NOT KNOW HOW THE PRODUCT WAS STORED. THEY PULLED ALL THE PRODUCT AND VALIDATED THAT THERE WASN'T ANY REMAINING IN THE NICU OR PEDIATRICS. THE PRODUCT WAS NOT USED ON AN INFANT AS THE NURSE IDENTIFIED THE ISSUE OPEN ACTIVATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15156310 ↗
• MalfunctionFeb 16, 2022Explosion; Explosion

  THE CUSTOMER REPORTED THAT THE PACK RUPTURED DURING ACTIVATION. THERE WAS NO HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13542806 ↗
• MalfunctionJun 21, 2021Burst Container or Vessel; Burst Container or Vessel

  THE CUSTOMER REPORTED THE NURSE HAD THE HEEL WARMER BURST ON THEM. THERE WAS NO HARM TO THE NURSE OR PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12031990 ↗
• MalfunctionMar 5, 2021Explosion; Explosion

  THE CUSTOMER REPORTED THAT THE NURSE WAS IN THE PROCESS OF ACTIVATING AN INFANT HEEL WARMER TO PREPARE FOR A BLOOD GLUCOSE. DURING THE ACTIVATION PROCESS THE WARMER EXPLODED AND SPEWED ITS CONTENTS ON THE NURSE AND MANY OBJECTS IN THE VICINITY INCLUDING THE FATHER OF THE BABY. ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER STATED THAT THERE WAS NO HARM OCCURRED TO THE STAFF OR THE PATIENT INVOLVED. NO MEDICAL INTERVENTION OR TREATMENT REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11421170 ↗
• MalfunctionMar 3, 2021Explosion; Explosion

  THE CUSTOMER REPORTED THAT THE INFANT HEEL WARMER EXPLODED IN ASSOCIATE'S FACE WHEN TRYING TO ACTIVATE. THE CUSTOMER REPORTED THAT INTERVENTION WAS REQUIRED BUT NO OTHER DETAILS WERE PROVIDED. ON (B)(6) 2021, THE CUSTOMER STATED THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 11408054 ↗
• InjuryJan 13, 2021Fluid/Blood Leak; Material Rupture; Fluid/Blood Leak; Material Rupture

  CUSTOMER REPORTS: DURING PRE ADMISSION TESTING WHEN USING A HEEL WARMER FOR A BLOOD DRAW THE HEEL WARMER BURST DURING ACTIVATION. THE CHEMICAL WENT INTO THE PATIENT'S LEFT EYE. THE PATIENT WAS A (B)(6) FEMALE. SUBSEQUENTLY HER EYES WERE FLUSHED OUT AND SHE HAD NO FURTHER SYMPTOMS UNTIL THE NEXT DAY WHEN SHE EXPERIENCED BURNING IN HER EYE AND TEMPORARILY LOST VISION IN THE LEFT EYE. THE PATIENT IS NOW BEING TREATED BY A SPECIALIST.

  Patient problems: Eye Burn

  MAUDE report 11168124 ↗
• MalfunctionSep 15, 2020Explosion; Explosion

  THE CUSTOMER REPORTED THAT THE HEEL WARMER WAS ACTIVATED PRIOR TO LAB ON INFANT. THE HEEL WARMER WAS EXPLODED IN RN'S HANDS, WHEN COMPRESSED. ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER STATED THAT THERE WAS NO INJURY TO THE PATIENT OR THE STAFF INVOLVED. THE STAFF FLUSHED THE CONTACTED AREAS AND SKIN WITH WATER AND CHANGED THE SCRUBS, AS APPROPRIATE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10535685 ↗
• MalfunctionSep 15, 2020Explosion; Explosion

  THE CUSTOMER REPORTED THAT THE NURSE WAS ACTIVATING A NEONATAL HEEL WARMER TO APPLY TO A PATIENT, BUT BEFORE IT REACHED THE PATIENT, THE ACTIVATED HEEL WARMER EXPLODED ON NURSE AND IN THE ROOM. ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER STATED THAT THERE WAS NO INJURY TO THE PATIENT OR THE STAFF INVOLVED. THE STAFF FLUSHED THE CONTACTED AREAS AND SKIN WITH WATER, AND CHANGED THE SCRUBS, AS APPROPRIATE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10535440 ↗
• MalfunctionSep 15, 2020Explosion; Explosion

  THE CUSTOMER REPORTED THAT THE INFANT HEEL WARMER WAS BEING SQUEEZED TO ACTIVATE IT, AND IT POPPED. IT SPRAYED CONTENTS ALL OVER THE CLOTHES AND FLOOR. ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER STATED THAT THERE WAS NO INJURY TO THE PATIENT OR THE STAFF INVOLVED. THE STAFF FLUSHED THE CONTACTED AREAS AND SKIN WITH WATER, AND CHANGED THE SCRUBS, AS APPROPRIATE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10535307 ↗
• MalfunctionAug 19, 2020Material Rupture; Activation Problem; Material Rupture; Activation Problem

  CUSTOMER REPORTS: THE RN SQUEEZED THE BAG TO PUNCTURE THE INNER BLADDER OF THE HEEL WARMER. THE OUTER BAG BROKE SPRAYING CONTENTS ON THE STAFF MEMBER CAUSING SKIN REDNESS AND BURNING ON THE FACE, NECK, AND CHEST. IT DOES NOT APPEAR THAT THERE WAS PERMANENT SCARRING.

  Patient problems: Skin Irritation

  MAUDE report 10428813 ↗
• MalfunctionJun 26, 2020Explosion; Explosion

  THE CUSTOMER REPORTED THAT THE HEAT PACK WAS BEING ACTIVATED. WHEN SQUEEZING THE HEAT PACK, IT EXPLODED ON THE ARMS, SCRUBS AND ON THE FACE. A SECOND HEAT PACK WAS SQUEEZED AND THE SAME THING HAS HAPPENED. THE PRODUCT FROM THE HEAT PACK WAS ON THE CUSTOMER, OVER THE FLOOR AND A NEARBY WALL AND ON THE TABLE. THE CUSTOMER FURTHER STATED THAT THE SKIN WAS WASHED AND THE SCRUBS WERE CHANGED. THERE WAS NO HARM TO THE PATIENT OR THE STAFF INVOLVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10203212 ↗
• MalfunctionJun 16, 2020Explosion; Explosion

  THE CUSTOMER REPORTED THAT SEVERAL HEEL WARMERS HAVE EXPLODED WHEN SQUEEZED TO ACTIVATE GOING ALL OVER THE NURSERY, EQUIPMENT AND CRIBS. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10157572 ↗
• MalfunctionMay 6, 2020Explosion; Explosion

  THE CUSTOMER REPORTED THAT THE INFANT HEEL WARMER POPPED IN THE ACUTE CARE AREA.

  Patient problems: No Consequences Or Impact To Patient; No Information

  MAUDE report 10029459 ↗
• MalfunctionApr 29, 2020Explosion; Explosion

  THE CUSTOMER REPORTED THAT A FEW HEEL WARMERS BROKE IN THEIR CLEAN UTILITY STORAGE SHELF.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10010103 ↗
• MalfunctionApr 29, 2020Burst Container or Vessel; Fluid/Blood Leak; Burst Container or Vessel; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT THE HEEL WARMER BROKE AND LEAKED ON THE INFANT'S BED. THERE WAS NO HARM TO THE PATIENT OR STAFF.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10008998 ↗
• MalfunctionApr 27, 2020Material Rupture; Material Rupture

  THE CUSTOMER REPORTED THAT THE HEEL WARMER POPPED WHICH RESULTED IN THE EMPLOYEE BEING SPLASHED IN THE EYE BY ITS CONTENTS. ADDITIONAL INFORMATION PROVIDED STATED THAT THE CONTENTS ALSO SPLASHED ON THE SKIN AND THE EMPLOYEE WAS NOT HARMED DURING THE INCIDENT. SDS GUIDELINES FOR EXPOSURE WERE FOLLOWED AND NO FURTHER MEDICAL ATTENTION WAS REQUIRED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10002411 ↗
• MalfunctionApr 23, 2020Explosion; Explosion

  THE CUSTOMER REPORTED THAT THE HEEL WARMER POPPED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9991906 ↗
• MalfunctionApr 22, 2020Explosion; Explosion

  THE CUSTOMER REPORTED THAT ALL THE CONTENTS OF THE PRODUCT SPILLED ONTO THE NURSE AND THE FLOOR. THERE WAS NO INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9988999 ↗
• MalfunctionApr 22, 2020Explosion; Explosion

  THE CUSTOMER REPORTED THAT ALL THE CONTENTS OF THE PRODUCT SPILLED ONTO THE NURSE AND THE FLOOR. THERE WAS NO INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9988997 ↗
• MalfunctionApr 22, 2020Explosion; Explosion

  THE CUSTOMER REPORTED THAT ALL THE CONTENTS OF THE PRODUCT SPILLED ONTO THE NURSE AND THE FLOOR. THERE WAS NO INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9988996 ↗
• MalfunctionApr 22, 2020Explosion; Explosion

  THE CUSTOMER REPORTED THAT THE PRODUCT HAD POPPED AND THE CONTENTS SPRAYED ONTO THE BABY. THERE WAS NO INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9988936 ↗
• MalfunctionApr 22, 2020Explosion; Explosion

  THE CUSTOMER REPORTED THAT THE PRODUCT HAD POPPED AND THE CONTENTS SPRAYED ONTO THE NURSE. THERE WAS NO INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9988851 ↗
• MalfunctionMar 19, 2020Explosion; Explosion

  THE CUSTOMER REPORTED THAT THE INFANT HEEL WARMER PACK EXPLODED WHEN SQUEEZED FOR ACTIVATION. NO PATIENT OR CLINICIAN HARM AT THIS TIME. THE ACTIVATED GEL SHOT OUT ALL OVER THE CARE PROVIDER AND SURROUNDING SPACE. THE ISSUE OCCURRED PRIOR TO PLACING ON THE INFANT AND WAS NOT ACTIVATED ON THE INFANT AS IT IS THEIR PRACTICE TO ACTIVATE AWAY FROM THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9856884 ↗
• MalfunctionMar 19, 2020Explosion; Explosion

  THE CUSTOMER REPORTED THAT THE INFANT HEEL WARMER PACK EXPLODED WHEN IT WAS SQUEEZED FOR ACTIVATION. THE ACTIVATED GEL PROJECTED OUT ONTO THE CARE PROVIDER. THIS OCCURRED PRIOR TO PLACEMENT ON THE INFANT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9856750 ↗
• MalfunctionMar 19, 2020Explosion; Explosion

  THE CUSTOMER REPORTED THAT THE INFANT HEEL WARMER PACK EXPLODED WHEN SQUEEZED FOR ACTIVATION. NO PATIENT OR CLINICIAN HARM AT THIS TIME. ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER STATED THAT THE ACTIVATED GEL SHOT OUT ALL OVER THE CARE PROVIDER AND SURROUNDING SPACE. THE ISSUE OCCURRED PRIOR TO PLACING ON THE INFANT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9856421 ↗