ARISTA AM0005Recalls & reported problems
Davol Inc. · Arista AH FlexiTip XL Applicator, 38 cm (15 in) · Class 3
All models of ARISTA (6)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- 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 00801741044076), received between Mar 29, 2024 and Mar 29, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Incomplete or Missing 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Incomplete or Missing 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.
MalfunctionMar 29, 2024Incomplete or Missing Packaging; Incomplete or Missing Packaging
AS REPORTED, THE SALES REP WAS AT THE HOSPITAL ASSISTING WITH CASES. IN BETWEEN CASES, NOTICED THE OR SUPPLY CLOSET WAS LOW ON FLEXITIP XL APPLICATORS. WHEN OPENED THE SEALED SHELF BOX FROM THE MAIN SUPPLY CLOSET, GRABBED SEVERAL APPLICATORS AND NOTICED ONE OF THE APPLICATORS WAS MISSING THE OUTER TYVEK POUCH (PRODUCT IS DOUBLE POUCHED). THE APPLICATOR WAS WITHIN THE INNER TYVEK POUCH, JUST MISSING THE SECOND OUTER POUCH, SO IT WAS SET ASIDE WITH A STAFF MEMBER, AND IT WAS DISCARDED AS A PRECAUTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19002840 ↗
Other Agent, absorbable hemostatic, non-collagen based devices
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- SURGICEL FIBRILLAR 1963Ethicon Sàrl · Agent, absorbable hemostatic, non-collagen based1 recall44 reports
- SURGICEL 1953Ethicon Sàrl · Agent, absorbable hemostatic, non-collagen based56 reports
- SURGICEL 1952Ethicon Sàrl · Agent, absorbable hemostatic, non-collagen based1 death41 reports
- SURGICEL FIBRILLAR 1962Ethicon Sàrl · Agent, absorbable hemostatic, non-collagen based35 reports
- Veriset HP0510ECovidien LP · Agent, Absorbable Hemostatic, Non-Collagen Based1 death33 reports
- SURGICEL SNoW 2082Ethicon, LLC · Agent, absorbable hemostatic, non-collagen based24 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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