NA 72203791Recalls & reported problems

Summary

The FDA's MAUDE database contains 43 adverse event reports that list this exact device (DI 00885554030419), received between Dec 7, 2017 and Feb 11, 2026 — classified as 6 injuries, 37 malfunctions.

The most frequently reported specific device problem is “Break” (22 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 43 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 11, 2026Failure to Capture; Detachment of Device or Device Component; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A ROTATOR CUFF PROCEDURE, THE PUNCTURE NEEDLE OF THE TRUEPASS SUTURE PASSER COULD NOT BE INSTALLED, AS IT APPEARED THAT THE SPRING AT THE DISTAL END HAD COME OUT. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A CHANGE IN SURGICAL TECHNIQUE TO MANUAL SUTURING. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24318570 ↗
• MalfunctionFeb 5, 2024Break; Break

  IT WAS REPORTED THAT DURING AN SHOULDER ARTHROSCOPY, THE TRUEPASS SUTURE PASSER'S MOUTH SYSTEM BROKE WITH THE NEEDLE IN PLACE, IT EVEN BROKE THE TIP OF THE NEEDLE. THE PROCEDURE WAS COMPLETED WITH A SMITH AND NEPHEW BACK UP DEVICE. THERE WAS A DELAY GREATER THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18639868 ↗
• MalfunctionJan 24, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE TRUEPASS SUTURE PASSER SELF-CAPTURE SPRING IN THE TOP JAW BROKE OUTSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED USING A S+N BACK UP DEVICE. THERE WAS NO SURGICAL DELAY, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18574517 ↗
• MalfunctionJan 17, 2024Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR, THE SELF-CAPTURE SPRING IN TOP JAW OF TRUEPASS BROKE. THE PROCEDURE WAS COMPLETED WITH A SMITH AND NEPHEW BACK UP DEVICE WITH NO SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18525891 ↗
• MalfunctionDec 19, 2023Break; Break

  IT WAS REPORTED THAT DURING SET UP THE TRUEPASS SUTURE PASSER BROKE. THERE WAS A BACK UP DEVICE AVAILABLE AND NO SURGICAL DELAY WAS REPORTED. NO PATIENT INVOLVEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18358592 ↗
• MalfunctionNov 6, 2023Break; Break

  IT WAS REPORTED THAT DURING A SHOULDER ROTATOR CUFF REPAIR, THE TRUEPASS SUTURE PASSER COULD NOT CLAMP THE SUTURE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SIGNIFICANT DELAY USING A BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED. PRELIMINARY RESULTS OF INVESTIGATION, IT WAS FOUND THAT THE SPRING ON THE SUTURE GRABBER AT THE DISTAL END OF THE SHAFT IS FRACTURED. THE TRUEPASS SUTURE NEEDLE IS DEFORMED AND THE TIP IS FRACTURED AWAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18079412 ↗
• MalfunctionOct 24, 2023Break; Break

  IT WAS REPORTED THAT DURING SET UP, THE TRUE PASS SUTURE PASSER SPRING BROKE ON THE SELF-CAPTURE MECHANISM. THERE WAS A BACK-UP DEVICE AVAILABLE AND NO DELAY WAS REPORTED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17996867 ↗
• MalfunctionJun 26, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A SHOULDER CUFF REPAIR, THE TRUEPASS SUTURE PASSER SPRING FELL OFF. THE SPRING WAS SUCCESSFULLY REMOVED FROM THE ARTICULAR CAVITY WITH PLIERS. A DELAY GREATER THAN 31 MINUTES WAS REPORTED. THE PROCEDURE WAS FINISHED WITH A SMITH AND NEPHEW BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17199585 ↗
• MalfunctionApr 13, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE SUTURE PASSERS OF THE TRUEPASS SUTURE PASSER DEVICE BREAK. IT IS UNKNOWN WHETHER THE EVENT HAPPENED DURING SURGERY AND IF THERE WAS PATIENT INVOLVEMENT AND IF THERE WAS A BACK UP DEVICE AVAILABLE OR IF THERE WAS A SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16732900 ↗
• InjurySep 19, 2022Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC PROCEDURE, THE TRUEPASS NEEDLE WINDOW WAS BROKEN; AND THE SPRING CAME OUT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NON-SIGNIFICANT SURGICAL DELAY USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15451890 ↗
• MalfunctionJun 19, 2022Break; Difficult to Open or Close; Break; Difficult to Open or Close

  IT WAS REPORTED THAT, DURING A ROTATOR CUFF REPAIR PROCEDURE, THE TRUEPASS SUTURE PASSER GRASPING MECHANISM COULD NOT OPEN OR CLOSE DUE TO A FAULTY SPRING MECHANISM. A PART OF THE JAW ALSO BROKE OFF. THE PROCEDURE WAS COMPLETED WITH A NON-SIGNIFICANT DELAY USING A SMITH AND NEPHEW BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14741334 ↗
• InjuryMar 22, 2022Break; Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR SURGERY, THE TIP OF THE (B)(6) (SELF-CAPTURE DOOR PART) BROKE INTO PIECES. ALL THE BROKEN PIECES WERE RETRIEVED FROM THE PATIENT WITH TWEEZERS. THE PROCEDURE WAS COMPLETED WITHOUT A SURGICAL DELAY USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13847387 ↗
• MalfunctionMar 15, 2022Break; Break

  IT WAS REPORTED THAT DURING SET UP OF A PROCEDURE, THE CLAMPING MECHANISM OF THE TRUEPASS BROKE INTO PIECES DURING THE WARRANTY PERIOD. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13775919 ↗
• MalfunctionJan 3, 2022Break; Break

  IT WAS REPORTED THAT, TRUEPASS SUTURE PASSER PLIER BROKE OFF THE TIP OF THE NEEDLE. NO CASE REPORTED, THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13142404 ↗
• MalfunctionSep 27, 2021Misassembled; Misassembled

  IT WAS REPORTED THAT THE MOVABLE SEGMENT OF THE TRUEPASS SUTURE PASSER TIP WAS NOT FIXED IN THE WORKING POSITION. IT IS UNKNOWN WHETHER THE EVENT HAPPENED DURING SURGERY AND IF THERE WAS A PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12537221 ↗
• MalfunctionJun 13, 2021Break; Break

  IT WAS REPORTED THAT WHEN THE NEEDLE OF THE TRUEPASS SUTURE PASSER WAS RELEASED, THE TIP BROKE OFF. THE INCIDENT OCCURRED BEFORE THE PROCEDURE. THERE WAS NO DELAY AND A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11988859 ↗
• MalfunctionMay 14, 2021Failure to Cycle; Failure to Cycle

  IT WAS REPORTED THAT, DURING A SHOULDER ROTATOR CUFF REPAIR, THE TRUEPASS SUTURE PASSER DID NOT TAPE AFTER FIRING. THE PROCEDURE WAS COMPLETED WITHOUT 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 11827607 ↗
• InjuryApr 28, 2021Firing Problem; Firing Problem

  IT WAS REPORTED THAT DURING A CUFF THROUGH-OUT SUTURING, THE THREAD CAPTURE MECHANISM OF THE TRUEPASS SUTURE PASSER HAD A FAILURE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY. A CLEVERHOOK J&J COMPETITOR DEVICE WAS USED TO COMPLETE THE SURGERY. 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 11737393 ↗
• MalfunctionApr 19, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT, DURING SET UP FOR A SHOULDER ARTHROSCOPY, A WIRE TURNED OUT FROM THE "TRUEPASS SUTURE PASSER, SELF CAPTURE". THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SIGNIFICANT DELAY USING A BACK-UP DEVICE. 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 11690742 ↗
• InjuryMar 30, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING SHOULDER ROTATOR CUFF REPAIR SURGERY, THE SPRING AT THE JAW PASSING SUTURE OF THE TRUEPASS WAS DEFORMED AND COULD NOT BE RETURNED BACK AFTER THE JAW WAS OVER WIRED AND COULD NOT BE USED. THERE WAS A CHANGE IN SURGICAL TECHNIQUE AND NO SIGNIFICANT DELAY 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 11590707 ↗
• MalfunctionMar 7, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING A SHOULDER SURGERY, WHEN SUTURING THE ROTATOR CUFF WITH A "TRUEPASS SUTURE PASSER (SELF-CAPTURE)"; THE SPRING ON THE CATCH MECHANISM PARTIALLY POPPED OUT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SIGNIFICANT DELAY USING A BACK-UP DEVICE. NO PARTS REMAINED IN THE PATIENT SINCE NOTHING BROKE OFF. NO 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 11429564 ↗
• InjuryFeb 23, 2021Break; Break

  IT WAS REPORTED THAT DURING THE ROTATOR CUFF PROCEDURE, WHEN THE FIRST-PASS WAS USED, THE NEEDLE COULD NOT BE DEPLOYED AND UPON CHECKING THE DEVICE, THE NEEDLE WAS FOUND BROKEN. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. NO DELAY OR 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 11369887 ↗
• MalfunctionFeb 5, 2021Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE CATCH MECHANISM OF THE TRUEPASS SUTURE PASSER WAS NO LONGER GRIPING THE THREAD CORRECTLY/RELIABLY. IT WAS NOT REPORTED IF THE DEVICE WAS USED IN SURGERY, OR IF THERE WAS PATIENT INVOLVEMENT. BUT IT WAS REPORTED THAT THERE WAS NO DELAY AND A BACK-UP DEVICE WAS 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 11283813 ↗
• MalfunctionJan 4, 2021Break; Break

  IT WAS REPORTED THAT, DURING A DEMONSTRATION, THE SPRING ON THE TOP OF THE HEAD IN THE "TRUEPASS SUTURE PASSER (SELF-CAPTURE)" JUMPED OUT AND DAMAGED. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. 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 11113722 ↗
• MalfunctionJan 3, 2021Break; Break

  IT WAS REPORTED THAT THE SPRING OF THE TRUEPASS SUTURE PASSER BROKE AND TORE. IT IS UNKNOWN WHETHER THE EVENT HAPPENED DURING SURGERY AND IF THERE WAS A PATIENT INVOLVEMENT. 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 11105946 ↗