AESCULAP MD355Recalls & reported problems
Aesculap, Inc. · RECTANGULAR MINI FILTERS 4X9 SMS POLYPRO · Class 2
- 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 04046964909900), received between Jun 27, 2025 and Jun 27, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Puncture/Hole” (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
- Material Puncture/Hole1
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 27, 2025Material Puncture/Hole; Material Puncture/Hole
ACCORDING TO THE CUSTOMER: " WE ARE HAVING ISSUES WITH HOLES IN AESCULAP FILTERS. THIS IS AN EVERYDAY OCCURRENCE. WE, IN (B)(6), HAVE RECOMMENDED EVERYTHING POSSIBLE TO AVOID CREATING HOLES IN FILTERS. I DO UNDERSTAND THERE ARE AREAS IN THE FILTERS THAT ARE LIGHT AND CAN LOOK LIKE HOLE IN FILTER BUT WE ARE RECEIVING REPORTS OF TINY HOLES. I DID INSPECT A NEW BAG. I PUT IT UP AGAINST A LIGHTED MAGNIFIER. THERE ARE AREAS THAT LOOK LIKE TINY PIN HOLES."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22350050 ↗
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- Halyard 34147O&M Halyard, Inc. · Wrap, sterilization3 reports
- Halyard 34199O&M Halyard, Inc. · Wrap, sterilization3 reports
- Halyard 34148O&M Halyard, Inc. · Wrap, sterilization3 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.