AESCULAP PL574TRecalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 04046963398828), received between Sep 22, 2020 and Feb 16, 2022 — classified as 6 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Unintended Ejection” (5 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

Recent adverse event reports

The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 16, 2022Unintended Ejection; Material Integrity Problem; Unintended Ejection; Material Integrity Problem

  IT WAS REPORTED TO AESCULAP AG THAT A CHALLENGER TI-P SM-LIGAT.CLIPS 12 CARTR (PART # PL574T) WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2022. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE CLIPS WERE USED TO CLIP SMALL BLOOD VESSELS, BUT THE CARTRIDGE FLOATED AND THE NEXT CLIP COULD NOT BE LOADED. THIS ISSUE OCCURRED THREE (3) TIMES IN A ROW. THE DOCTOR ATTEMPTED TO USE A FOURTH CARTRIDGE, BUT THE USE WAS STOPPED. WHEN THE DEFECTIVE CARTRIDGES WERE CHECKED, THE CLAW AT THE BASE WAS FOUND TO BE BROKEN. THE AFFECTED AREA WAS SEARCHED, BUT ONLY ONE (1) OF THE THREE (3) CLIPS WERE ABLE TO BE RETRIEVED. ALTHOUGH AN INEXPERIENCED SCRUB NURSE WAS IN-CHARGE, VETERAN STAFF INSTRUCTED INSTALLATION AND OPERATION OF DEVICE. REPORTEDLY, ALL SETTINGS WERE CORRECT. THE COMPLAINT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. THE PATIENT HAS NO INFECTION, BUT THE CLAW PART OF THE CARTRIDGE MIGHT HAVE FALLEN INSIDE THE BODY. AN ADDITIONAL MEDICAL INTERVENTION WAS NECESSARY. ALTHOUGH REQUESTED, ADDITIONAL INFORMATION HAS NOT BEEN MADE AVAILABLE. THE ADVERSE EVENT IS FILED UNDER AAG REFERENCE (B)(4).

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 13546124 ↗
• MalfunctionNov 7, 2021Unintended Ejection; Material Fragmentation; Unintended Ejection; Material Fragmentation

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH PL574T - CHALLENGER TI-P SM-LIGAT.CLIPS 12 CARTR. ACCORDING TO THE COMPLAINT DESCRIPTION, IT IS NOT MOUNTED ON THE CLIP HOLDER BECAUSE THE END IS BROKEN. THERE WAS NO DESCRIBED PATIENT HARM. ADDITIONAL INFORMATION WAS NOT PROVIDED. ADDITIONAL PATIENT INFORMATION IS NOT AVAILABLE. THE MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12762410 ↗
• MalfunctionNov 7, 2021Unintended Ejection; Unintended Ejection

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH PL574T-CHALLENGER TI-P SM-LIGAT.CLIPS 12 CARTR. ACCORDING TO THE COMPLAINT DESCRIPTION, IT WAS REPORTED THAT THE END OF THE CARTRIDGE IS DAMAGED AND DIFFICULT TO FIX WHEN MOUNTED. THE PART WHERE THE CARTRIDGE IS INSERTED INTO THE DEVICE IS SO SMALL AND TRANSPARENT THAT IT BREAKS EASILY. THERE WAS NO DESCRIBED PATIENT HARM. ADDITIONAL INFORMATION WAS NOT PROVIDED NOR AVAILABLE / WAS NOT AVAILABLE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED AS OF THIS REPORT. ADDITIONAL PATIENT INFORMATION IS NOT AVAILABLE. THE ADVERSE EVENT / MALFUNCTION IS FILED UNDER (B)(4). ASSOCIATED MEDWATCH-REPORTS 9610612-2021-00703 ((B)(4) PL574T).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12762267 ↗
• MalfunctionNov 7, 2021Unintended Ejection; Unintended Ejection

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH PL574T-CHALLENGER TI-P SM-LIGAT.CLIPS 12 CARTR. ACCORDING TO THE COMPLAINT DESCRIPTION, IT WAS REPORTED THAT THE END OF THE CARTRIDGE IS DAMAGED AND DIFFICULT TO FIX WHEN MOUNTED. THE PART WHERE THE CARTRIDGE IS INSERTED INTO THE DEVICE IS SO SMALL AND TRANSPARENT THAT IT BREAKS EASILY. THERE WAS NO DESCRIBED PATIENT HARM. ADDITIONAL INFORMATION WAS NOT PROVIDED NOR AVAILABLE / WAS NOT AVAILABLE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED AS OF THIS REPORT. ADDITIONAL PATIENT INFORMATION IS NOT AVAILABLE. THE ADVERSE EVENT / MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4). ASSOCIATED MEDWATCH-REPORTS 9610612-2021-00703 ((B)(4) PL574T) 9610612-2021-00702 ((B)(4) PL574T)

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12762061 ↗
• MalfunctionAug 10, 2021Failure to Eject; Failure to Eject

  IT WAS REPORTED TO AESCULAP AG THAT A CHALLENGER TI-P SM-LIGAT. CLIPS 12 CARTR (PART # PL574T) WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2021. ACCORDING TO THE COMPLAINT, THE CLIP WAS JAMMED AND CAME OFF. AFTER LOADING THE FIRST SHOT, THE CLIP WAS JAMMED AND MAGAZINE CAME OFF AND FELL INTO THE BODY. THERE WAS NO DESCRIBED PATIENT HARM. ALTHOUGH REQUESTED, ADDITIONAL INFORMATION HAS NOT BEEN MADE AVAILABLE. THE MALFUNCTION IS FILED UNDER (B)(4) REFERENCE XC (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12304659 ↗
• InjuryAug 2, 2021Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH PL574T - CHALLENGER TI-P SM-LIGAT.CLIPS 12 CARTR. ACCORDING TO THE COMPLAINT DESCRIPTION, THE CLIP GOT JAMMED. EVEN AFTER THE CLIP WAS REATTACHED, IT WAS NOT IMPROVED AND THE USE WAS STOPPED. AN ADDITIONAL MEDICAL INTERVENTION WAS NECESSARY. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED AS OF THIS REPORT. ADDITIONAL PATIENT INFORMATION IS NOT AVAILABLE. THE ADVERSE EVENT IS FILED UNDER AAG REFERENCE (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12259480 ↗
• MalfunctionJul 14, 2021Unintended Ejection; Unintended Ejection

  UPDATE: THIS CASE IS ASSOCIATED WIT FOLLOWING MDR NUMBER 9610612-2021-00500 (400518301 PL574T), 9610612-2021-00539 (400518302 PL574T), 9610612-2021-00501 (400518303 PL572T).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12166069 ↗
• MalfunctionJul 8, 2021Failure to Eject; Failure to Eject

  IT WAS REPORTED TO AESCULAP AG THAT A CHALLENGER TI-P SM-LIGAT. CLIPS 12 CARTR (PART # PL574T) WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2021. ACCORDING TO THE COMPLAINANT, THE APPLICATORS WERE BLOCKED IN THE PATIENT'S BODY. THE CLIP PLASTIC SUPPORT ALSO BROKE IN THE PATIENT'S BODY. THE FRAGMENT REMAINED IN SITU. THE COMPLAINT DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT HARM HAS BEEN REPORTED. 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 12134899 ↗
• InjuryMay 26, 2021Material Fragmentation; Material Fragmentation

  IT WAS REPORTED TO AESCULAP AG THAT A CHALLENGER TI-P SM-LIGAT.CLIPS 12 CARTR (PART # PL574T) WAS USED DURING A HEPATECTOMY PROCEDURE PERFORMED ON (B)(6) 2021. ACCORDING TO THE COMPLAINANT, TWO CLIPS WERE PLACED DURING THE HEPATECTOMY PROCEDURE. REPORTEDLY, A COMPUTERIZED TOMOGRAPHY (CT) SCAN WAS PERFORMED WHICH REVEALED THAT THE CARTRIDGE WAS BETWEEN OMENTUM. THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2021. THE COMPLAINT DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. A REVISION SURGERY WAS NECESSARY. ALTHOUGH REQUESTED, ADDITIONAL INFORMATION HAS NOT BEEN MADE AVAILABLE. THE ADVERSE EVENT IS FILED UNDER AAG REFERENCE (B)(4). INVOLVED COMPONENTS: PL522R - SHAFT COMPL.D:5MM L:310MM. PL520R - CHALLENGER TI-P HANDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11887082 ↗
• InjuryMar 23, 2021Deformation Due to Compressive Stress; Mechanical Jam; Deformation Due to Compressive Stress; Mechanical Jam

  ASSOCIATED MEDWATCH-REPORTS: 9610612-2021-00213 (400504842 - PL574T).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11552982 ↗
• InjuryMar 23, 2021Deformation Due to Compressive Stress; Mechanical Jam; Deformation Due to Compressive Stress; Mechanical Jam

  ASSOCIATED MEDWATCH-REPORTS: 9610612-2021-00213 (400504842 - PL574T); 9610612-2021-00212 (400504843 + PL574T).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11552797 ↗
• InjuryFeb 11, 2021Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT THERE PL574T - CHALLENGER TI-P SM-LIGAT.CLIPS 12 CARTRIDGE DETACHED/BROKE DURING SURGERY. ACCORDING TO THE COMPLAINT DESCRIPTION, CARTRIDGE USED FOR LAPAROSCOPIC HEPATECTOMY ON (B)(6). THERE WAS NO PROBLEM WITH THE FIRST SHOT, BUT THE MAGAZINE CAME OFF IN THE ABDOMINAL CAVITY WITH THE SECOND SHOT. A PART OF THE MAGAZINE WAS MISSING AND SUSPECTED TO REMAIN IN THE BODY. CARTRIDGE WAS DISCARDED. AN ADDITIONAL MEDICAL INTERVENTION WAS NECESSARY. ADDITIONAL INFORMATION WAS NOT PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED AS OF THIS REPORT. THE ADVERSE EVENT IS FILED UNDER AAG REFERENCE (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 11313942 ↗
• MalfunctionFeb 3, 2021Break; Break

  IT WAS REPORTED TO AESCULAP AG THAT THERE WAS AN ISSUE WITH CHALLENGER TI-P LIGATION CLIP (PART # PL574T) WAS USED DURING AN UNKNOWN PROCEDURE PERFORMED ON (B)(6) 2021. ACCORDING TO THE COMPLAINANT, THE MAGAZINE WAS REPLACED, THE CLAWS WERE BROKEN AND FOUND ON THE INSTRUMENT TABLE. SECOND, WHEN ANOTHER MAGAZINE WAS TAKEN OUT OF THE ABDOMINAL CAVITY AFTER THE SECOND NEEDLE STRIKE, THE MAGAZINE WAS NOT ON THE SHAFT AND THE MAGAZINE WAS FOUND IN THE ABDOMINAL CAVITY. THE CLAW WAS FOUND IN THE SHAFT CAVITY OF THE APPLIER. THE COMPLAINT DEVICE WAS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. 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 11276413 ↗
• MalfunctionSep 25, 2020Break; Break

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH CHALLENGER TI-P SM-LIGAT. CLIPS 12 CARTR. ACCORDING TO THE CUSTOMER DESCRIPTION, IT WAS REPORTED THAT DURING PANCREATIC SURGERY THE CARTRIDGE WAS USED AND FOUND THAT THE CARTRIDGE WAS BROKEN WHEN THEY TRIED TO USE IT AND IT FELL INTO THE PATIENT'S ABDOMEN. THE SURGEON FOUND IT RIGHT AWAY, AND THERE HAS BEEN A SURGICAL DELAY FOR 5-10 MINUTES TO REPLACE WITH NEW CARTRIDGE. IT WAS NOTED THAT THERE WAS NO HARM TO THE PATIENT. ADDITIONAL PATIENT INFORMATION IS NOT AVAILABLE. THE ADVERSE EVENT / MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10586815 ↗
• MalfunctionSep 22, 2020Mechanical Problem; Mechanical Problem

  IT WAS REPORTED TO AESCULAP AG THAT A CHALLENGER TI-P LIGATURE CLIPS DEVICE WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, THE LIGATURE CLIPS CARTRIDGE DETACHED FROM THE SHAFT. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS OCCURRED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT HAS NOT YET BEEN RECEIVED. NO PATIENT DETAILS WERE MADE AVAILABLE. THE ADVERSE EVENT / MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10566856 ↗
• MalfunctionSep 22, 2020Mechanical Problem; Mechanical Problem

  IT WAS REPORTED TO AESCULAP AG THAT A CHALLENGER TI-P LIGATURE CLIPS DEVICE WAS USED DURING A CHOLECYSTECTOMY PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, THE LIGATURE CLIPS CARTRIDGE DETACHED FROM THE SHAFT. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE EVENT LED A PROCEDURAL DELAY OF APPROXIMATELY FIVE (5) TO TEN (10) MINUTES. NO PATIENT COMPLICATIONS OCCURRED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT HAS NOT YET BEEN RECEIVED. NO PATIENT DETAILS WERE MADE AVAILABLE. THE MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10566720 ↗
• MalfunctionSep 22, 2020Mechanical Problem; Mechanical Problem

  IT WAS REPORTED TO AESCULAP AG THAT A CHALLENGER TI-P LIGATURE CLIPS DEVICE WAS USED DURING A PANCREATECTOMY PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, THE LIGATURE CLIPS CONSECUTIVELY FIRED WITHOUT BEING TRIGGERED. THE EVENT LED A PROCEDURAL DELAY OF APPROXIMATELY FIVE (5) TO TEN (10) MINUTES. NO KNOWN PATIENT COMPLICATIONS OCCURRED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT HAS NOT YET BEEN RECEIVED. NO PATIENT DETAILS WERE MADE AVAILABLE. THE MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10566542 ↗