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A&E Medical / Disposable Suction Coagulator 050-030Recalls & reported problems

A & E Medical Corporation · Suction Coagulator, 1 per pouch · Class 2

Data updated Oct 18, 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 10841291104926), received between Jan 21, 2021 and Jan 21, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Fragmentation” (1 report).

2 other recalls cover devices cleared under the same FDA submission (K881413); they may or may not involve this specific model.

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 18, 2026.

Most reported problems

Device problems

  • Material Fragmentation1

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.

  • MalfunctionJan 21, 2021Material Fragmentation; Material Fragmentation

    THE CUSTOMER REPORTED THAT THE SUCTION COAGULATOR WAS READY TO BE USED BUT BEFORE THEY COULD USE IT, THE TIP BROKE OFF.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11209706 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K881413. One submission often covers many models, so check the product and lot details in each record.

  • Z-0771-2014 · Dec 19, 2013 · Terminated
    Weck, Electrosurgical Coagulation Suction Tube 8 (20.0cm), 11 French, with Stylet, Teleflex Medical, Research Triangle, NC 27709. Intended to remove tissue and control bleeding by
  • Z-0770-2014 · Dec 19, 2013 · Terminated
    Weck, Electrosurgical Coagulation Suction Tube 6 (15.2cm), 11 French, with Stylet, Teleflex Medical, Research Triangle, NC 2770. Intended to remove tissue and control bleeding by

Other Electrosurgical, Cutting & Coagulation & Accessories devices

All Electrosurgical, Cutting & Coagulation & Accessories devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page