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ARISTA AM0010Recalls & reported problems

Davol Inc. · Arista AH FlexiTip XL-R Applicator, 38 cm (15 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 00801741096808), received between Jul 10, 2019 and Jul 10, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Expiration Date Error” (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.

Most reported problems

Device problems

  • Expiration Date Error1
  • Use of Device Problem1

Patient problems

  • No Consequences Or Impact To Patient1

Recent adverse event reports

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

  • MalfunctionJul 10, 2019Use of Device Problem; Expiration Date Error; Use of Device Problem; Expiration Date Error

    IT WAS REPORTED THAT THE USER FACILITY WAS PERFORMING A MINIMALLY INVASIVE IVOR-LEWIS ESOPHAGECTOMY WITH GASTRIC PULL-UP ON (B)(6) 2019. AT THE CLOSE OF THE CASE, IT WAS DISCOVERED THAT AN EXPIRED FLEXI-TIP APPLICATOR WITH ARISTA HEMOSTATIC AGENT HAD BEEN USED DURING THE CASE. THERE WAS NO ADVERSE PATIENT OUTCOME AND NO ADDITIONAL MEDICAL OR SURGICAL INTERVENTION REQUIRED.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8777749 ↗

Other Agent, absorbable hemostatic, non-collagen based devices

All Agent, absorbable hemostatic, non-collagen based devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.