Valutrus JJ55BRecalls & reported problems

Summary

The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 10705036002239), received between Jun 13, 2022 and Apr 25, 2025 — classified as 36 malfunctions.

The most frequently reported specific device problem is “Device Markings/Labelling Problem” (27 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 25 most recent of 36 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 25, 2025Failure to Fire; No Apparent Adverse Event; Failure to Fire; No Apparent Adverse Event

  IT WAS REPORTED THAT DURING A LAP COLON PROCEDURE THE SURGICAL TEAM ENCOUNTERED A CRITICAL ISSUE WITH THE RELOAD CARTRIDGES USED IN CONJUNCTION WITH LINEAR CUTTER. WHEN THE CARTRIDGES WERE LOADED AND STAPLER WAS FIRED ON TISSUE . THE TISSUE WAS ONLY TRANSACTED BUT STAPLE FORMATION DIDN'T TAKE PLACE .

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21908454 ↗
• MalfunctionAug 8, 2024Difficult to Insert; Device Markings/Labelling Problem; Difficult to Insert; Device Markings/Labelling Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THERE WAS A CARTRIDGE INSTALLATION ISSUE. IT WAS REPORTED THAT DURING THE SURGERY, THE CARTRIDGE COULD NOT BE INSTALLED. CHECKED THE RELOADS AND FOUND THERE WERE NO SAFETY-LOCK ON BOTH SIDES OF RELOADS. CHANGED THE NEW ONE TO COMPLETE SURGERY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19944576 ↗
• MalfunctionAug 8, 2024Difficult to Insert; Device Markings/Labelling Problem; Difficult to Insert; Device Markings/Labelling Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THERE WAS A CARTRIDGE INSTALLATION ISSUE. IT WAS REPORTED THAT DURING THE SURGERY, THE CARTRIDGE COULD NOT BE INSTALLED. CHECKED THE RELOADS AND FOUND THERE WERE NO SAFETY-LOCK ON BOTH SIDES OF RELOADS. CHANGED THE NEW ONE TO COMPLETE SURGERY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19942623 ↗
• MalfunctionAug 8, 2024Difficult to Insert; Device Markings/Labelling Problem; Difficult to Insert; Device Markings/Labelling Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THERE WAS A CARTRIDGE INSTALLATION ISSUE. IT WAS REPORTED THAT DURING THE SURGERY, THE CARTRIDGE COULD NOT BE INSTALLED. CHECKED THE RELOADS AND FOUND THERE WERE NO SAFETY-LOCK ON BOTH SIDES OF RELOADS. CHANGED THE NEW ONE TO COMPLETE SURGERY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19942581 ↗
• MalfunctionApr 5, 2023Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, NO SAFETY-LOCK-OUT. IT WAS REPORTED THAT OPENED THE PACKING AND THE DISTRIBUTOR NOTED THAT THE JJ55B RELOAD DOES NOT HAVE SAFETY-LOCK-OUT. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16681314 ↗
• MalfunctionApr 5, 2023Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, NO SAFETY-LOCK-OUT. IT WAS REPORTED THAT OPENED THE PACKING AND THE DISTRIBUTOR NOTED THAT THE JJ55B RELOAD DOES NOT HAVE SAFETY-LOCK-OUT. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16681305 ↗
• MalfunctionApr 5, 2023Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, NO SAFETY-LOCK-OUT. IT WAS REPORTED THAT OPENED THE PACKING AND THE DISTRIBUTOR NOTED THAT THE JJ55B RELOAD DOES NOT HAVE SAFETY-LOCK-OUT. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16681278 ↗
• MalfunctionApr 5, 2023Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, NO SAFETY-LOCK-OUT. IT WAS REPORTED THAT OPENED THE PACKING AND THE DISTRIBUTOR NOTED THAT THE JJ55B RELOAD DOES NOT HAVE SAFETY-LOCK-OUT. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16681265 ↗
• MalfunctionApr 5, 2023Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, NO SAFETY-LOCK-OUT. IT WAS REPORTED THAT OPENED THE PACKING AND THE DISTRIBUTOR NOTED THAT THE JJ55B RELOAD DOES NOT HAVE SAFETY-LOCK-OUT. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16681198 ↗
• MalfunctionJan 27, 2023Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT THEY OPENED THE PACKING, AND IT WAS NOTED THAT THE JJ55B RELOADS DO NOT HAVE SAFETY-LOCK-OUT. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16252679 ↗
• MalfunctionJan 27, 2023Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT THEY OPENED THE PACKING, AND IT WAS NOTED THAT THE JJ55B RELOADS DO NOT HAVE SAFETY-LOCK-OUT. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16252668 ↗
• MalfunctionJan 27, 2023Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT THEY OPENED THE PACKING, AND IT WAS NOTED THAT THE JJ55B RELOADS DO NOT HAVE SAFETY-LOCK-OUT. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16252641 ↗
• MalfunctionJan 27, 2023Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT THEY OPENED THE PACKING, AND IT WAS NOTED THAT THE JJ55B RELOADS DO NOT HAVE SAFETY-LOCK-OUT. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16252619 ↗
• MalfunctionJan 27, 2023Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT THEY OPENED THE PACKING, AND IT WAS NOTED THAT THE JJ55B RELOADS DO NOT HAVE SAFETY-LOCK-OUT. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16252596 ↗
• MalfunctionJan 27, 2023Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT THEY OPENED THE PACKING, AND IT WAS NOTED THAT THE JJ55B RELOADS DO NOT HAVE SAFETY-LOCK-OUT. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16252584 ↗
• MalfunctionJan 27, 2023Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT THEY OPENED THE PACKING, AND IT WAS NOTED THAT THE JJ55B RELOADS DO NOT HAVE SAFETY-LOCK-OUT. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16252575 ↗
• MalfunctionJan 27, 2023Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT THEY OPENED THE PACKING, AND IT WAS NOTED THAT THE JJ55B RELOADS DO NOT HAVE SAFETY-LOCK-OUT. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16252563 ↗
• MalfunctionJan 27, 2023Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT THEY OPENED THE PACKING, AND IT WAS NOTED THAT THE JJ55B RELOADS DO NOT HAVE SAFETY-LOCK-OUT. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16252551 ↗
• MalfunctionJan 27, 2023Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT THEY OPENED THE PACKING, AND IT WAS NOTED THAT THE JJ55B RELOADS DO NOT HAVE SAFETY-LOCK-OUT. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16252541 ↗
• MalfunctionJan 27, 2023Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT THEY OPENED THE PACKING, AND IT WAS NOTED THAT THE JJ55B RELOADS DO NOT HAVE SAFETY-LOCK-OUT. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16252537 ↗
• MalfunctionJan 27, 2023Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT THEY OPENED THE PACKING, AND IT WAS NOTED THAT THE JJ55B RELOADS DO NOT HAVE SAFETY-LOCK-OUT. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16252528 ↗
• MalfunctionNov 29, 2022Difficult to Insert; Material Integrity Problem; Difficult to Insert; Material Integrity Problem

  IT WAS REPORTED THAT THERE ARE 3 JJ55B CARTRIDGES, ONE IS SEAL PACKED, THE OTHER IS OPEN BUT STAPLE RETAINING CAP IS STILL THERE, THE 3RD THE SAFETY LOCK WAS BROKEN, THERE WAS AN ALIGNMENT PROBLEM AS THE CARTRIDGES WERE NOT FITTING/ALIGNING PROPERLY IN THE CARTRIDGE FORK (NOT GETTING FIT INTO THE FORK). THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15877450 ↗
• MalfunctionNov 29, 2022Difficult to Insert; Material Integrity Problem; Difficult to Insert; Material Integrity Problem

  IT WAS REPORTED THAT THERE ARE 3 JJ55B CARTRIDGES, ONE IS SEAL PACKED, THE OTHER IS OPEN BUT STAPLE RETAINING CAP IS STILL THERE, THE 3RD THE SAFETY LOCK WAS BROKEN, THERE WAS AN ALIGNMENT PROBLEM AS THE CARTRIDGES WERE NOT FITTING/ALIGNING PROPERLY IN THE CARTRIDGE FORK (NOT GETTING FIT INTO THE FORK). THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15877447 ↗
• MalfunctionNov 29, 2022Difficult to Insert; Material Integrity Problem; Insufficient Device Problem Information; Difficult to Insert; Material Integrity Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT THERE ARE 3 JJ55B CARTRIDGES, ONE IS SEAL PACKED, THE OTHER IS OPEN BUT STAPLE RETAINING CAP IS STILL THERE, THE 3RD THE SAFETY LOCK WAS BROKEN, THERE WAS AN ALIGNMENT PROBLEM AS THE CARTRIDGES WERE NOT FITTING/ALIGNING PROPERLY IN THE CARTRIDGE FORK (NOT GETTING FIT INTO THE FORK). THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15876312 ↗
• MalfunctionNov 14, 2022Difficult to Insert; Material Integrity Problem; Difficult to Insert; Material Integrity Problem

  IT WAS REPORTED THAT AFTER OPENING THE PACKING, THE SURGEON NOTED THAT IT IS VERY DIFFICULT TO INSTALL THE CARTRIDGE. CAREFULLY CHECKED THE RELOAD, THE OPERATOR FOUND THE RELOAD APPEARANCE WAS DIFFERENT WITH THE NORMAL ONES, WHICH DID NOT HAVE SAFETY LOCK. THERE WAS NO SAFETY-LOCK ON BOTH SIDES OF THE RELOAD. NO PHOTOS AVAILABLE. CHANGED TO ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION COULD BE PROVIDED. PROCEDURE: UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15787932 ↗