AESCULAP US751Recalls & reported problems

Summary

The FDA's MAUDE database contains 50 adverse event reports that list this exact device (DI 04038653473731), received between Feb 5, 2020 and Jun 11, 2026 — classified as 1 injury, 49 malfunctions.

The most frequently reported specific device problem is “Material Puncture/Hole” (41 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 50 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 11, 2026Material Discolored

  CUSTOMER HAS CONCERN ABOUT BROWN STAINING ON FILTERS. THIS INCIDENT OCCURRED ON (B)(6) 2026 AND CAUSED A DELAY TO A CASE. APPROXIMATELY (3) FILTERS SHOWED THE BROWN STAINS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25470343 ↗
• MalfunctionMay 28, 2026Material Puncture/Hole

  DISTRIBUTOR STATED CUSTOMER REPORTED THAT FILTERS HAVE BEEN NOTED TO HAVE PIN PRICK HOLES IN THE FILTERS. THE LOT IS NOT KNOWN AS IT IS UNCLEAR WHEN THE PROCESSING OF THE DEVICES OCCURRED - LOT THEREFORE CANNOT BE DETERMINED BASED ON STOCK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25317386 ↗
• MalfunctionMay 6, 2026Material Puncture/Hole

  IT WAS REPORTED THAT THERE WERE PIN HOLES OBSERVED IN THE FILTERS WHILE OPENING THE STERILIZATION CONTAINER FOR A PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25100894 ↗
• MalfunctionFeb 13, 2026Material Puncture/Hole

  AS REPORTED BY THE FACILITY: "THERE WERE BLACK MARKS ON THE INDICATOR CIRCLES ON THE FILTERS. IT APPEARS THEY WERE PARTIALLY EXPOSED TO HEAT OF SOME TYPE OF MACHINE ERROR.." NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24331787 ↗
• MalfunctionFeb 12, 2026Material Puncture/Hole

  AS REPORTED BY THE FACILITY: "WE HAD MULTIPLE BAGS OF FILTERS WITH WEAK SPOTS OR PIN HOLES IN THEM. WE DID A ROOT CAUSE ANALYSIS AND COULD LOCATE A CAUSE FROM THE TRAYS INVESTIGATED." NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24323918 ↗
• MalfunctionAug 18, 2025Product Quality Problem; Residue After Decontamination; Product Quality Problem; Residue After Decontamination

  AS REPORTED BY THE USER FACILITY: AS ADVISED, WE WILL INSPECT AND CONTINUE TO REJECT THE STERILIZATION FILTERS, NOT ONLY FOR THE MICRO HOLES WE ARE FINDING BUT NOW FOR THE NEW IMPERFECTION, THE BLACK INK LINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22826370 ↗
• MalfunctionAug 7, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THERE WERE PIN HOLES OBSERVED IN THE FILTERS. WHEN THE FILTERS ARE HELD UP TO THE LIGHT AND EXAMINED WITH THE NAKED EYE, THE BLUE COLOR SEEMS VARIED AND THERE ARE WHITE SPOTS THAT ARE EITHER VARIATION IN THE MATERIAL (IN THE NAP OR FILTER WEAVE PATTERN, A THINNER KNAP) OR HOLES. REPORTEDLY THE HOLE IN THE FILTER LINES UP EXACTLY WITH THE HOLE IN THE LID.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22736755 ↗
• MalfunctionAug 5, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THERE WERE PIN HOLES OBSERVED IN THE FILTERS. WHEN THE FILTERS ARE HELD UP TO THE LIGHT AND EXAMINED WITH THE NAKED EYE, THE BLUE COLOR SEEMS VARIED AND THERE ARE WHITE SPOTS THAT ARE EITHER VARIATION IN THE MATERIAL (IN THE NAP OR FILTER WEAVE PATTERN, A THINNER KNAP) OR HOLES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22714255 ↗
• MalfunctionAug 5, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THERE WERE PIN HOLES OBSERVED IN THE FILTERS. WHEN THE FILTERS ARE HELD UP TO THE LIGHT AND EXAMINED WITH THE NAKED EYE, THE BLUE COLOR SEEMS VARIED AND THERE ARE WHITE SPOTS THAT ARE EITHER VARIATION IN THE MATERIAL (IN THE NAP OR FILTER WEAVE PATTERN, A THINNER KNAP) OR HOLES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22714254 ↗
• 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 SPD, 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 22344789 ↗
• MalfunctionJun 26, 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 SPD, 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 22337334 ↗
• MalfunctionJun 24, 2025Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE EVENT DESCRIPTION: CUSTOMER FOUND SMALL PIN HOLES IN SEVERAL OF THE FILTERS IN ONE OF THEIR BAGS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22322580 ↗
• MalfunctionJun 18, 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 SPD, 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 22286610 ↗
• InjuryJun 16, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH A COMPONENT OF AN AS VEGA SYSTEM. ACCORDING TO THE COMPLAINT DESCRIPTION, THIS KNEE IMPLANT WAS "DEFECTIVE AND FAILED PREMATURELY BECAUSE THE CERAMIC COATED SURFACE FAILS TO PROPERLY ADHERE TO THE CEMENT". THERE WAS POSTOPERATIVE MECHANICAL LOOSENING. IT WAS NOTED THAT THE SURGEON EASILY REMOVED THE IMPLANT BY HAND DURING THE REVISION. ADDITIONAL INFORMATION WAS NOT PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 22210709 ↗
• MalfunctionJun 13, 2025Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE COMPLAINANT THE FILTERS HAVE MICRO PIN HOLES. REPORTEDLY THE PIN HOLES WERE FOUND UPON INSPECTION OF NEW FILTERS FROM THE PACKAGE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22205755 ↗
• MalfunctionJun 2, 2025Material Puncture/Hole; Product Quality Problem; Material Puncture/Hole; Product Quality Problem

  AS REPORTED BY THE USER FACILITY: EVENT 3. CUSTOMER IS INSPECTING HOLES IN FILTERS WHEN FILTER IS REFLECTING SUN AND LIGHT IN CERTAIN WAYS. CUSTOMER COULD NOT PROVIDE A LOT NUMBER BUT GAVE 4 FILTER SAMPLES. ONE UNUSED AND 3 USED. THE FILTERS AROUND THE WORD AESCULAP SEEM LIGHTER UNDER LIGHT IN CERTAIN AREAS AND CUSTOMER CIRCLED THE HOLES. ONE SAMPLE IS FROM A 2023 FILTER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22122458 ↗
• MalfunctionJun 2, 2025Material Puncture/Hole; Product Quality Problem; Material Puncture/Hole; Product Quality Problem

  AS REPORTED BY THE USER FACILITY: EVENT 4: CUSTOMER IS INSPECTING HOLES IN FILTERS WHEN FILTER IS REFLECTING SUN AND LIGHT IN CERTAIN WAYS. CUSTOMER COULD NOT PROVIDE A LOT NUMBER BUT GAVE 4 FILTER SAMPLES. ONE UNUSED AND 3 USED. THE FILTERS AROUND THE WORD AESCULAP SEEM LIGHTER UNDER LIGHT IN CERTAIN AREAS AND CUSTOMER CIRCLED THE HOLES. ONE SAMPLE IS FROM A 2023 FILTER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22122312 ↗
• MalfunctionJun 2, 2025Material Puncture/Hole; Product Quality Problem; Material Puncture/Hole; Product Quality Problem

  AS REPORTED BY THE USER FACILITY: EVENT 1: CUSTOMER IS INSPECTING HOLES IN FILTERS WHEN FILTER IS REFLECTING SUN AND LIGHT IN CERTAIN WAYS. CUSTOMER COULD NOT PROVIDE A LOT NUMBER BUT GAVE 4 FILTER SAMPLES. ONE UNUSED AND 3 USED. THE FILTERS AROUND THE WORD AESCULAP SEEM LIGHTER UNDER LIGHT IN CERTAIN AREAS AND CUSTOMER CIRCLED THE HOLES. ONE SAMPLE IS FROM A 2023 FILTER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22122234 ↗
• MalfunctionJun 2, 2025Material Puncture/Hole; Product Quality Problem; Material Puncture/Hole; Product Quality Problem

  AS REPORTED BY THE USER FACILITY: EVENT 2: CUSTOMER IS INSPECTING HOLES IN FILTERS WHEN FILTER IS REFLECTING SUN AND LIGHT IN CERTAIN WAYS. CUSTOMER COULD NOT PROVIDE A LOT NUMBER BUT GAVE 4 FILTER SAMPLES. ONE UNUSED AND 3 USED. THE FILTERS AROUND THE WORD AESCULAP SEEM LIGHTER UNDER LIGHT IN CERTAIN AREAS AND CUSTOMER CIRCLED THE HOLES. ONE SAMPLE IS FROM A 2023 FILTER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22122233 ↗
• MalfunctionMay 14, 2025Material Puncture/Hole; Material Puncture/Hole

  SUPPLIER REPORTS HOLES ARE SHOWING UP IN FILTERS. AFTER CUSTOMER EXAMINED THESE FILTERS, THEY HAD WEAK SPOTS IN THEM, AND WHEN THEY WERE PROCESSED THEY CREATED PIN HOLE SIZED HOLES. CUSTOMER FOUND UNUSED FILTERS WITH PIN HOLES AS WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22019959 ↗
• MalfunctionApr 21, 2025Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE EVENT DESCRIPTION: THERE ARE HOLES ARE SHOWING UP IN FILTERS AFTER STERILE PROCESSING. AFTER EXAMINING THE FILTERS, THEY HAD WEAK SPOTS IN THEM, AND WHEN THEY WERE PROCESSED, THEY CREATED PIN HOLE SIZED HOLES. REPORTEDLY THERE WERE UNUSED FILTERS WITH PIN HOLES AS WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21877429 ↗
• MalfunctionFeb 6, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED TO AESCULAP INC. THAT A ROUND FILTERS W/INDICATOR (PART# US751) WAS USED FOR DURING STERILIZATION ON (B)(6) 2025. ACCORDING TO THE COMPLAINANT THERE IS A STRAIGHT LINE GOING THROUGH THE TOP OF THE FILTER THAT WAS SEEN POST STERILIZATION. REPORTEDLY THERE WAS A DELAY OF 5 MINUTES TO THE PROCEDURE AS ANOTHER SET HAD TO BE PULLED. THE ADVERSE EVENT IS FILED UNDER AIC REFERENCE (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21324239 ↗
• MalfunctionSep 27, 2024Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE COMPLAINANT THERE WERE HOLES IN THE CONTAINER FILTERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20326128 ↗
• MalfunctionFeb 27, 2024Illegible Information; Illegible Information

  THE USER FACILITY REPORTED THAT THE INDICATOR DOT ON THEIR ROUND FILTERS WITH INDICATOR ARE NOT "UNIFORMLY DARK BROWN" AFTER PROCESSING. PROCEDURE CANCELLATIONS WERE REPORTED AS THE DEVICES WERE NOT UTILIZED AND WERE REPROCESSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18791195 ↗
• MalfunctionFeb 27, 2024Illegible Information; Illegible Information

  THE USER FACILITY REPORTED THAT THE FILTER INDICATOR DOT DID NOT FULLY CHANGE IN COLOR. A PROCEDURE DELAY WAS REPORTED AS THE DEVICES WERE NOT UTILIZED AND WERE REPROCESSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18791167 ↗