ACCU-PASS 7210423Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 03596010534446), received between Dec 7, 2018 and Apr 28, 2026 — classified as 6 injuries, 20 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 26 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 28, 2026Break; Material Deformation

  IT WAS REPORTED THAT THE ACCUPASS SUTURE PASSER WAS BENT AND BROKEN. THE PROCEDURE WAS RESUMED WITHOUT ANY DELAY, USING A SIMILAR S+N BACK UP PRODUCT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25024179 ↗
• MalfunctionDec 2, 2025Break; Break

  IT WAS REPORTED THAT, DURING A SHOULDER INSTABILITY PROCEDURE, WHEN THE SURGEON WAS TAKING A BITE OF THE LABRUM, AN ACCU-PASS GOT BROKEN. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING A SIMILAR S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23700898 ↗
• MalfunctionNov 25, 2025Break; Break

  IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY PROCEDURE, AN ACCU-PASS PROBE BROKE, AS THE METAL PART DETACHED FROM THE PLASTIC. THE BROKEN PART WAS REMOVED FROM THE PATIENT USING TWEEZERS. THE PROCEDURE WAS PERFORMED USING A SIMILAR S+N BACK UP PRODUCT, WITH AN UNSPECIFIED SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23647924 ↗
• MalfunctionSep 16, 2024Break; Break

  IT WAS REPORTED THAT, DURING SURGERY, THE CURVED PART OF A ACCU-PASS DIRECT SNAPPED OFF WHEN INSERTED INTO THE JOINT. THE BROKEN PART WAS REMOVED FROM THE PATIENT WITH AN ARTHROSCOPIC GRASPER. SURGERY WAS COMPLETED WITH A BACK-UP DEVICE INSTEAD. THERE WAS A DELAY OF LESS THAN 30 MINUTES, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20224763 ↗
• MalfunctionJan 30, 2024Detachment of Device or Device Component; Material Integrity Problem; Detachment of Device or Device Component; Material Integrity Problem

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE TWO GUIDES OF THE ACCU-PASS HAD A PROBLEM. SPECIFICALLY, WHEN PASSING THE SUTURE AND TURNING THE WHEELS, THE GUIDE CAME OFF. WHEN THE USER REVIEWED THE GUIDES, THEY SHOWED DETERIORATION AND BREAKAGE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SURGICAL DELAY USING A SMITH AND NEPHEW BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18607740 ↗
• MalfunctionJul 17, 2023Break; Break

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY, THE ACCUPASS BROKE WHEN TRYING TO SUTURE THE MENISCUS, THE AREA WAS OF DIFFICULT ACCESS. SURGERY WAS COMPLETED WITHOUT DELAY, USING A BACK-UP DEVICE INSTEAD. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17339332 ↗
• InjuryJun 27, 2022Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY, TWO ACCU-PASS SUTURE FAILED THE SAME WAY, THE LASSO 45 DEGREE SUTURE GOT STUCK INSIDE LASSO. ANOTHER INCISION HAD TO BE DONE IN ORDER TO BYPASS, THUS AN EXTRA ARTHROSCOPY PORTAL HAD TO BE DONE. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED OR IF THERE WAS A DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Needle Stick/Puncture

  MAUDE report 14838127 ↗
• InjuryFeb 9, 2022Break; Break

  IT WAS REPORTED THAT DURING USE IN A LEFT SHOULDER ARTHROSCOPIC BONY BANKART LABRAL REPAIR, WHEN THE DR. WAS USING THE ACCU-PASS SUTURE SHUTTLE, THE METAL SHAFT BROKE OFF OF THE PLASTIC HANDLE. IT IS UNKNOWN IF THERE WAS A DELAY OR IF A BACKUP DEVICE WAS AVAILABLE AND HOW THE ISSUE WAS RESOLVED. X-RAY COMPLETED TO ENSURE NO PIECES WERE IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13497934 ↗
• MalfunctionJul 6, 2021Failure to Cycle; Failure to Cycle

  IT WAS REPORTED THAT, DURING A SHOULDER ARTHROSCOPY, AN ACCU-PASS DEVICE WOULD NOT PASS THE SUTURE, THE DEVICE WAS UNUSABLE. THE PROCEDURE WAS COMPLETED WITH A S+N BACK UP DEVICE. THERE WAS A DELAY OF MORE THAN 30 MIN, NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12125236 ↗
• MalfunctionJun 7, 2021Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY PROCEDURE, WHEN THE ACCU-PASS PACKAGE WAS OPENED, THE DIAL WAS STUCK FROM THE BEGINNING, THEREFORE, THE SUTURE COULD NOT BE ROLLED OUT. THE PROCEDURE WAS COMPLETED WITH A BACKUP DEVICE WITH NO PATIENT INJURY. A DELAY OF 20 MINUTES WAS REPORTED AND NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11944955 ↗
• MalfunctionMay 18, 2021Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY CASE, THE ACCU-PASS MONOFILAMENT SUTURE WAS NOT PASSING SMOOTHLY AND THE WHEELS IN THE DEVICE ARE DIFFICULT TO USE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT A SIGNIFICANT DELAY USING A BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11841054 ↗
• MalfunctionMay 8, 2021Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING SET UP OR INSPECTION FOR AN ARTHROSCOPY, WHEN THE ACCU-PASS WAS JUST NEWLY OPEN, THE ROLLER TO CONTROL THE MONOFILAMENT WAS ALREADY VERY HARD TO ROLL AND ADJUST THE MONOFILAMENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE. NO PATIENT INVOLVED AT THE MOMENT OF THE INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11795317 ↗
• MalfunctionApr 8, 2021Firing Problem; Firing Problem

  IT WAS REPORTED THAT DURING A SURGERY THE MONOFILAMENT OF THE ACCUPASS 45 DEGREE WOULD NOT SHUTTLE. 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 11633270 ↗
• InjuryFeb 11, 2021Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY THE ACCU-PASS THUMB WHEEL WAS ROTATING ON ONE SIDE ONLY, SUTURE DOES NOT FEED INTO THE DEVICE ON ROLLING THE WHEEL. THERE WAS CHANGE IN THE SURGICAL TECHNIQUE AND NO SIGNIFICANT DELAY OR FURTHER 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 11319211 ↗
• MalfunctionJan 15, 2021Delivered as Unsterile Product

  IT WAS REPORTED THAT DURING ARTHROSCOPIC SHOULDER SURGERY, THE PACKAGE OF THE ACCU-PASS 45-DEGREE WAS OPENED AND FOREIGN BODIES WERE FOUND IN THE STERILIZED PACKAGE. THE PROCEDURE WAS COMPLETED WITH A SMITH AND NEPHEW BACK UP DEVICE. NO PATIENT INJURY, DELAYS 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 11175978 ↗
• InjuryDec 10, 2020Material Too Rigid or Stiff; Material Too Rigid or Stiff

  IT WAS REPORTED THAT, DURING A LEFT SHOULDER STABILIZATION PROCEDURE, WHEN THE SURGEON WAS ATTEMPTING TO PASS THE "ACCUPASS LEFT CURVE 45°" THROUGH LABRUM AT 5 O'CLOCK POSITION, THE NYLON LOOP COULD NOT WIND OUT DESPITE SURGEON CONTINUING TO SCROLL THE WHEEL. THEREFORE, THE ACCUPASS WAS REMOVED FROM THE JOINT AND NURSE ATTEMPTED RE-THREADING A NEW NYLON LOOP, RE-STRAIGHTENING THE NYLON, OFF-SETTING LIMB LENGTHS, AND IT STILL DID NOT SLIDE OUT DESPITE TURNING THE WHEEL. A BACK UP DEVICE WAS AVAILABLE AND FINALLY, THE SURGEON WAS ABLE TO FINISH THE CASE AFTER WITH NO SIGNIFICANT DELAYS. NO FURTHER 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 10987701 ↗
• InjuryDec 10, 2020Material Too Rigid or Stiff; Material Too Rigid or Stiff

  IT WAS REPORTED THAT, DURING A LEFT SHOULDER STABILIZATION PROCEDURE, WHEN THE SURGEON WAS ATTEMPTING TO PASS THE "ACCUPASS LEFT CURVE 45°" THROUGH LABRUM AT 5 O'CLOCK POSITION, THE NYLON LOOP COULD NOT WIND OUT DESPITE SURGEON CONTINUING TO SCROLL THE WHEEL. THEREFORE, THE ACCUPASS WAS REMOVED FROM THE JOINT AND NURSE ATTEMPTED RE-THREADING A NEW NYLON LOOP, RE-STRAIGHTENING THE NYLON, OFF-SETTING LIMB LENGTHS, AND IT STILL DID NOT SLIDE OUT DESPITE TURNING THE WHEEL,THE NYLON STOPPED SLIDING OUT HALF WAY, ALLOWING ONLY A SMALL AMOUNT OF THE LOOP TO BE EXPOSED. THE SURGEON WAS ABLE TO USE A GRASPER TO PULL THE SUTURE THROUGH LOOP; HOWEVER, IT WAS UNABLE TO REMOVED THE ACCUPASS FROM THE JOINT FOR FEAR OF PULLING THE NYLON LOOP WITH IT. IN CONSEQUENCE, THE SURGEON HAD TO BEND THE ACCUPASS TO ALLOW ROOM FOR GRASPER WITHIN CANNULA, WHICH BENT SHAFT/HANDLE OF ACCUPASS ON REMOVAL THE JOINT. FINALLY, THE SURGEON WAS ABLE TO FINISH THE CASE AFTER WITH NO SIGNIFICANT DELAYS. NO FURTHER 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 10987657 ↗
• MalfunctionSep 25, 2020Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING ARTHROSCOPY, THE ACCUPASS FAILED TO LOAD THE SUTURE BEFORE BEING USED. THE STAFF TRIED TO LOAD THE DEVICE THREE TIMES AND WAS UNSUCCESSFUL. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING A S+N BACKUP 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 Known Impact Or Consequence To Patient

  MAUDE report 10590533 ↗
• MalfunctionAug 6, 2020Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT DURING AN ARCR PROCEDURE, THE FILAMENT CAME OUT OF THE WHEEL AND IT COULD NOT BE ADVANCED AT ALL. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A S&N 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 Known Impact Or Consequence To Patient

  MAUDE report 10376281 ↗
• MalfunctionJun 10, 2020Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT DURING ARTHROSCOPY PROCEDURE, THE MONOFILAMENT WAS CAME OUT OF THE WHEEL AND IT COULD NOT BE ADVANCED AT ALL. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO SIGNIFICANT DELAY OR OTHER COMPLICATION REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10140148 ↗
• InjuryJun 5, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY SURGERY THE FRONY HEAD OF THE ACCU-PASS BROKE OFF WHEN THE SUTURE HOOK IS INSERTED, ALL THE BROKEN PIECES WERE REMOVED USING A GRASPER. NO DELAY WAS REPORTED. SURGERY WAS FINISHED WITH THE SAME DEVICE. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10123574 ↗
• MalfunctionDec 26, 2019Failure to Eject; Failure to Eject

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, AN ACCU-PASS LEFT 45 ° WAS USED TO PASS THE SUTURE POINTS OF THE ANCHOR IN THE "LABRUM" TISSUE. WHEN THE POINT WAS PASSED, THE ACCU-PASS WAS ROLLED SO THAT THE MONOFILAMENT CAME OUT, IT WAS RECOVERED BUT WHEN PULLING IT, ONLY HALF CAME OUT BECAUSE IT WAS LOCKED AND IT DID NOT ADVANCE ANYMORE. WHEN TRYING TO REMOVE THE ACCU-PASS FROM THE TISSUE WITHOUT THE MONOFILAMENT, THE TISSUE WAS TORN AND AN ANCHOR POINT WAS LOST. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A BACK-UP DEVICE. IT IS UNKNOWN IF THERE WAS ANY DELAY AS A RESULT OF THE DEVICE MALFUNCTION. 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: Rupture

  MAUDE report 9519729 ↗
• MalfunctionDec 26, 2019Failure to Eject; Failure to Eject

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, AN ACCU-PASS LEFT 45 ° WAS USED TO PASS THE SUTURE POINTS OF THE ANCHOR IN THE "LABRUM" TISSUE. WHEN THE POINT WAS PASSED, THE ACCU-PASS WAS ROLLED SO THAT THE MONOFILAMENT CAME OUT, IT WAS RECOVERED BUT WHEN PULLING IT, ONLY HALF CAME OUT BECAUSE IT WAS LOCKED AND IT DID NOT ADVANCE ANYMORE. WHEN TRYING TO REMOVE THE ACCU-PASS FROM THE TISSUE WITHOUT THE MONOFILAMENT, THE TISSUE WAS TORN AND AN ANCHOR POINT WAS LOST. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A BACK-UP DEVICE. IT IS UNKNOWN IF THERE WAS ANY DELAY AS A RESULT OF THE DEVICE MALFUNCTION. 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: Rupture

  MAUDE report 9519676 ↗
• MalfunctionDec 10, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A PROCEDURE, THE DEVICE BROKE OFF WHILE TRYING TO PASS A SUTURE THROUGH THE LABRUM. ALL THE PIECES WERE REMOVED. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE AND A DELAY OF 1 MINUTE WAS REPORTED. THERE WAS NO PATIENT INJURY REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9447535 ↗
• MalfunctionSep 25, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE DEVICE ORANGE SHAFT BROKE AND THE METALLIC PART DETACHED INSIDE THE CANNULA. THE PROCEDURE WAS SUCCESSFULLY COMPLETE WITH A BACK UP DEVICE. THERE WAS A 1.5 HOURS DELAY REPORTED AND NO PATIENT INJURIES OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9120959 ↗