Argyle MH00002NRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 30884527004625), received between Jan 11, 2021 and Jan 11, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Fluid/Blood Leak” (1 report).

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 11, 2021Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  THE CUSTOMER REPORTED THAT THEIR LAB TEAM REPORTED A SKIN PUNCTURE FROM THE INFANT HEEL WARMER . THE LAB MANAGER REPORTED THAT ONE OF THEIR BLOOD COLLECTORS WAS USING THIS PRODUCT AND A PIECE OF HARDENED GEL FROM THE INTERIOR PIERCED THE BAG AND STUCK IN HER FINGER. IT WAS A SMALL LACERATION WHICH WAS NOT CONTAMINATED. NO TREATMENT WAS REQUIRED.

  Patient problems: Laceration(s)

  MAUDE report 11148335 ↗