ACCU-PASS 72200419Recalls & reported problems

Summary

The FDA's MAUDE database contains 55 adverse event reports that list this exact device (DI 03596010542397), received between Dec 18, 2019 and May 29, 2021 — classified as 7 injuries, 48 malfunctions.

The most frequently reported specific device problem is “Mechanical Jam” (18 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 55 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 29, 2021Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT DURING TAN ACL PROCEDURE, WHEN THE PACKAGE OF THE ACCU-PASS SUTURE WAS OPENED, IT WAS NOTICED THAT THE DIAL WAS STUCK FROM THE BEGINNING AND THE DEVICE COULD NOT ROLL THE SUTURE OUT OF IT. PROCEDURE FINISHED WITH S&N BACKUP DEVICE. SURGICAL DELAY OF 20 MINUTES. NO SURGICAL DELAY OR INJURY TO PATIENT REPORTED DUE THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11905742 ↗
• MalfunctionMay 28, 2021Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING SURGERY, THE ACCU-PASS SUTURE SHUTTLE DID NOT WORK, THE MONO-FILAMENT WAS NOT FEEDING THROUGH THE DEVICE. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11905475 ↗
• MalfunctionMay 21, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY PROCEDURE, THE WHEELS INTERMITTENTLY STICK OR BECOMING INCREASINGLY DIFFICULT TO SPIN AND ADVANCE THE MONOFILAMENT OF THE ACCU-PASS SUTURE SHUTTLE. BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE. NO SIGNIFICANT DELAY AND NO PATIENT INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11862695 ↗
• MalfunctionMay 21, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY PROCEDURE, THE WHEELS INTERMITTENTLY STICK OR BECOMING INCREASINGLY DIFFICULT TO SPIN AND ADVANCE THE MONOFILAMENT OF THE ACCU-PASS SUTURE SHUTTLE. BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE. NO SIGNIFICANT DELAY AND NO PATIENT INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11862678 ↗
• MalfunctionMay 19, 2021Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT DURING A LABRAL REPAIR, THE MONOFILAMENTS WERE GETTING STUCK IN THE ACCU-PASS SUTURE SHUTTLE 70 DEGREE. THE PROCEDURE WAS COMPLETED USING A BACK-UP DEVICE. A DELAY OF 30 MINUTES OR LESS WAS REPORTED. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11850001 ↗
• MalfunctionMay 19, 2021Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT DURING A LABRAL REPAIR, THE MONOFILAMENTS WERE GETTING STUCK IN THE ACCU-PASS SUTURE SHUTTLE 70 DEGREE. THE PROCEDURE WAS COMPLETED USING A BACK-UP DEVICE. A DELAY OF 30 MINUTES OR LESS WAS REPORTED. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11849963 ↗
• MalfunctionMay 19, 2021Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT DURING A LABRAL REPAIR, THE MONOFILAMENTS WERE GETTING STUCK IN THE ACCU-PASS SUTURE SHUTTLE 70 DEGREE . THE PROCEDURE WAS COMPLETED USING A BACK-UP DEVICE. A DELAY OF 30 MINUTES OR LESS WAS REPORTED. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11847948 ↗
• MalfunctionMay 13, 2021Difficult to Advance; Difficult to Advance

  IT WAS REPORTED THAT, DURING SURGERY, THE "ACCUPASS SUTURE SHUTTLE 70°" DID NOT PASS THE SUTURE PROPERLY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE. NO PATIENT INJURIES OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11823043 ↗
• MalfunctionMay 1, 2021Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING ARTHROSCOPY PROCEDURE, INSIDE THE PATIENT, THE ACCU-PASS SUTURE SHUTTLE 70 DEGREE COULD NOT ROLL THE MONOFILAMENT OUT OF DEVICE. THE PROCEDURE WAS FINISHED WITH A SMITH AND NEPHEW BACKUP DEVICE. NO PATIENT INJURY OR DELAY WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11758657 ↗
• MalfunctionApr 6, 2021Firing Problem; Firing Problem

  IT WAS REPORTED THAT, DURING AN UNKNOWN PROCEDURE, WHEN THE ACCU-PASS PACKAGE WERE OPENED, THE DIAL WAS STUCK FROM THE BEGINNING AND THE ACCU-PASS COULD NOT ROLL THE SUTURE OUT OF DEVICE. IT IS UNKNOWN IF THERE WAS A DELAY OR IF A BACKUP DEVICE WAS AVAILABLE AND HOW THE ISSUE WAS RESOLVED. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11619041 ↗
• MalfunctionMar 30, 2021Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT DURING A SURGERY WHEN THE ACCU-PASS PACKAGE WAS OPENED THE DIAL WAS STUCK AND WAS NOT ABLE TO ROLL THE SUTURE OUT OF THE DEVICE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11592339 ↗
• MalfunctionMar 19, 2021Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT DURING A SURGERY, WHEN THE ACCU-PASS PACKAGE WAS OPENED, IT WAS NOTICED THAT THE DIAL WAS STUCK AND IT COULD NOT ROLL THE SUTURE OUT OF DEVICE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11522229 ↗
• MalfunctionMar 11, 2021Failure to Cycle; Failure to Cycle

  IT WAS REPORTED THAT, DURING AN UNKNOWN PROCEDURE, THE ACCU-PASS SUTURE SHUTTLE 70 DEGREE COULD NOT ROLL THE SUTURE OUT OF DEVICE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11465440 ↗
• MalfunctionFeb 10, 2021Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT DURING SHOULDER SCOPE PROCEDURE, ABOUT 4 INCHES, THE ACCU-PASS SUTURE SHUTTLE STOPPED ADVANCING. THE WHEELS STOPPED MOVING, BOUND UP INSIDE. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO DELAY OR PATIENT INJURIES. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11312087 ↗
• InjuryFeb 10, 2021Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT DURING A SHOULDER PROCEDURE, ABOUT 4 INCHES, THE ACCU-PASS SUTURE SHUTTLE STOPPED ADVANCING. THE WHEELS STOPPED MOVING, BOUND UP INSIDE. THE PROCEDURE WAS COMPLETED WITH COMPETITOR DEVICE WITH NO DELAY OR OTHER COMPLICATIONS. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11310560 ↗
• MalfunctionFeb 2, 2021Difficult to Advance; Difficult to Advance

  IT WAS REPORTED THAT, DURING A SHOULDER ARTHROSCOPY, UPON REMOVAL THE "ACCUPASS 70° (UPBEND, STERILE)" FROM STERILE PACKAGE, THE SURGEON WAS UNABLE TO ADVANCE THE BLACK MONOFILAMENT WITH WHEELS ON HANDLE. UPON REMOVAL AND RE-FEEDING THE MONOFILAMENT, THE ADVANCEMENT REMAINED VERY DIFFICULT/STICKY. A SECOND MONOFILAMENT (FROM PACKAGE) WAS THEN LOADED WITH SIMILAR FEEDBACK BEEN DIFFICULT/STICKY IN HANDLE. FINALLY, THE SURGEON WAS ABLE TO COMPLETE PROCEDURE WITH SAME DEVICE. NO SIGNIFICANT DELAY AND NO PATIENT INJURIES OR OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11266787 ↗
• MalfunctionJan 26, 2021Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY WHEN THE ACCU-PASS PACKAGE WAS OPENED, THE DEVICE WAS NOT ROLLING THE MONOFILAMENT OUT OF THE DEVICE. THE PROCEDURE WAS COMPLETED WITH A BACKUP DEVICE, IT IS UNKNOWN IF THERE WAS A DELAY IN THE PROCEDURE. NO PATIENT COMPLICATIONS REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11232382 ↗
• MalfunctionJan 26, 2021Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY WHEN THE ACCU-PASS PACKAGE WAS OPENED, THE DEVICE WAS NOT ROLLING THE MONOFILAMENT OUT OF THE DEVICE. THE PROCEDURE WAS COMPLETED WITH A BACKUP DEVICE, IT IS UNKNOWN IF THERE WAS A DELAY IN THE PROCEDURE. NO PATIENT COMPLICATIONS REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11232332 ↗
• InjuryJan 26, 2021Firing Problem; Firing Problem

  IT WAS REPORTED THAT DURING A SHOULDER SCOPE AND SUBSCAPULAR REPAIR PROCEDURE, THE MONOFILAMENT OF THE ACCU-PASS ADVANCED OUT OF THE TIP ONLY ABOUT 2 INCHES BEFORE IT STOPPED. SAME ISSUE OCCURRED WITH THE SECOND MONOFILAMENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SIGNIFICANT DELAY USING THE SAME DEVICE BY TAKING OUT THE SECOND MONOFILAMENT WITH A HEMOSTAT. NO OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11228904 ↗
• MalfunctionJan 14, 2021Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT DURING PROCEDURE, WHEN THE PACKAGE WAS OPENED, THE ACCU-PASS COULD NOT ROLL THE MONOFILAMENT OUT OF DEVICE. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE WITH NO PATIENT INJURY OR DELAY. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11170189 ↗
• MalfunctionJan 7, 2021Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT DURING ROTATOR CUFF REPAIR SURGERY, THE ACCU-PASS 70 DEGREE PASSER WOULD NOT PASS THE MONOFILAMENT. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO SIGNIFICANT DELAY OR OTHER COMPLICATIONS. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11134471 ↗
• MalfunctionJan 7, 2021Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT DURING ROTATOR CUFF REPAIR SURGERY, THE ACCU-PASS 70 DEGREE PASSER WOULD NOT PASS THE MONOFILAMENT. THIS HAS BEEN AN ISSUE IN THE PAST THAT SEEMS TO HAVE EMERGED AGAIN. NO SIGNIFICANT DELAY OR OTHER COMPLICATIONS WERE REPORTED. IT IS UNKNOWN IF THERE WAS A BACKUP AVAILABLE. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11131770 ↗
• MalfunctionDec 30, 2020Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT DURING SURGERY, THE LASSO WHEELS OF THE 70° ACCUPASS WERE STIFF AND NOT SMOOTHLY PASSING THE MONOFILAMENT AS IT USUALLY DOES. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO DELAY OR PATIENT INJURIES. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11095491 ↗
• MalfunctionDec 29, 2020Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT DURING SURGERY, THE LASSO WHEELS OF THE 70° ACCUPASS WERE STIFF AND NOT SMOOTHLY PASSING THE MONOFILAMENT AS IT USUALLY DOES. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO DELAY OR PATIENT INJURIES. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11091258 ↗
• MalfunctionDec 23, 2020Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT, DURING AN ARCR SURGERY, WHEN THE PACKAGE WAS OPENED, THE ACCU-PASS COULD NOT ROLL THE MONOFILAMENT OUT OF DEVICE. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11069284 ↗