ARISTA AM0004Recalls & reported problems
Davol Inc. · Arista AH FlexiTip Applicator, 14 cm (5.5 in) · Class 3
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10801741044066), received between Jun 16, 2025 and Jun 16, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Tear, Rip or Hole in Device Packaging” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Tear, Rip or Hole in Device Packaging1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 16, 2025Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
AS REPORTED, DURING SET UP OF A PROCEDURE ON (B)(6) 2025, ONE UNIT OF ARISTA AH FLEXITIP APPLICATOR PACKAGING/POUCH WAS TORN AND UNUSABLE. A NEW UNIT WAS USED FOR THE PROCEDURE AND THE OUTER BOX WAS NOT DAMAGED. THIS WAS THE ONLY DAMAGED POUCH IN THE PRODUCT CARTON.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22212795 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.