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AESCULAP MD613Recalls & reported problems

Aesculap, Inc. · ANDREWS Suction Tube, 9", (225 mm), non-sterile, reusable · Class 1

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04046964570575), received between Apr 14, 2022 and Apr 14, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Material Separation” (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

  • Material Separation1

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.

  • InjuryApr 14, 2022Material Separation; Material Separation

    IT WAS REPORTED TO AESCULAP INC. THAT AN ANDREWS PYNCHON SUCTION TUBE 225MM (PART # MD613) WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2022. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE SUCTION TIP BECAME LOOSE AND SEPARATED IN THE STERIL FIELD. THE TIP WAS RETRIEVED IN THE PATIENT. THE COMPLAINT DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 14112431 ↗

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