AESCULAP JK090Recalls & reported problems
Aesculap AG · Reusable Filter, package of 10 pieces, diam. 190 mm · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04038653202690), received between May 26, 2021 and Jun 29, 2021 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Material Split, Cut or Torn” (2 reports).
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 Split, Cut or Torn2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 29, 2021Material Split, Cut or Torn; Material Split, Cut or Torn
IT WAS REPORTED TO AECULAP (B)(4) THAT A REUSABLE FILTER FOR CONTAINER (PART # JK090) WAS DAMAGED. ACCORDING TO THE COMPLAINANT, THE FILTER WAS TORN. THE COMPLAINT DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT INVOLVEMENT. ALTHOUGH REQUESTED, ADDITIONAL INFORMATION HAS NOT BEEN MADE AVAILABLE. THE MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12087565 ↗MalfunctionMay 26, 2021Material Split, Cut or Torn; Material Split, Cut or Torn
IT WAS REPORTED TO AESCULAP AG THAT A REUSABLE FILTER FOR CONTAINER (PART # JK090) WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2021. ACCORDING TO THE COMPLAINANT, THE FILTERS APPEARS TORN AT THE BASE, IN THE CENTER. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. ALTHOUGH REQUESTED, ADDITIONAL INFORMATION HAS NOT BEEN MADE AVAILABLE. THE MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11890449 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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