FIRSTPASS 22-4038Recalls & reported problems

Summary

The FDA's MAUDE database contains 189 adverse event reports that list this exact device (DI 00885556724545), received between Jun 15, 2020 and May 18, 2026 — classified as 61 injuries, 128 malfunctions.

The most frequently reported specific device problem is “Break” (108 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 189 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 18, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING A SHOULDER SURGERY WITH ROTATOR CUFF REPAIR, THE SELF CAPTURER OF ONE (1) FIRSTPASS SUTURE PASSER CAME OUT OF THE INSTRUMENT IN THE FIRST BITE ITSELF. 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 25202440 ↗
• MalfunctionMay 13, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A SHOULDER ROTATOR CUFF REPAIR, A PIECE OF METAL OF TWO (2) FIRST PASS CAME LOOSE. NO PIECES WERE LEFT INSIDE PATIENTS BODY. THE PROCEDURE WAS RESUMED AFTER A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACK UP PRODUCT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25166670 ↗
• MalfunctionMay 11, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING A PROCEDURE, THE UPPER JAW OF THE FIRSTPASS SUTURE PASSER WAS MISSING. THE PROCEDURE WAS RESUMED, USING AN EQUIVALENT SN BACK-UP. IT IS UNKNOWN IF THERE WAS A DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25136172 ↗
• MalfunctionMay 1, 2026Break; Material Deformation; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING A ROTATOR CUFF SURGERY, THE FIRSTPASS ST SUTURE PASSER WAS SUCCESSFUL UNTIL THE FIFTH ATTEMPT, THE TIP OF THE FIRSTPASS BROKE, THE NEEDLE BENT, AND THE DEVICE GOT STUCK; THEY COULDN¿T GET IT OUT BECAUSE IT WAS CAUGHT IN THE CUFF. PRIOR TO THE BREAKAGE, NO EXCESSIVE FORCE OR TWISTING WAS APPLIED TO THE DEVICE. ULTIMATELY, THE NEEDLE WAS ALSO COMPLETELY DETACHED/BROKEN WHEN THE DEVICE WAS REMOVED FROM THE PATIENT. NO FOREIGN OBJECTS REMAINED IN THE PATIENT. THE PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY, USING A SIMILAR S&N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25058369 ↗
• MalfunctionApr 22, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT THE SUTURE CATCHER OF TWO FIRSTPASS SUTURE PASSERS WAS MISSING. THE EXACT MOMENT AT WHICH THE ISSUE WAS NOTICED IS UNKNOWN; HOWEVER, IT WAS REPORTED THAT THE PROCEDURE WAS COMPLETED WITH A BACK-UP DEVICE, INSTEAD. IT IS UNKNOWN IF THERE WAS SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24960520 ↗
• MalfunctionMar 12, 2026Break

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPIC PROCEDURE, THE METAL PIECE ON THE TIP OF THE FIRSTPASS BROKE OFF AND SLID DOWN THE SUTURE TO THE CUFF. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24579076 ↗
• MalfunctionMar 7, 2026Break

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY, THE SUTURE PASSER FLAP OF THE FIRST PASS BROKE AFTER CATCHING THE TISSUE FOR 3 TIMES. THE PROCEDURE WAS COMPLETED WITH A SURGICAL DELAY OF LESS THAN 30 MINUTES USING A SIMILAR S&N BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24541652 ↗
• MalfunctionMar 7, 2026Break; Firing Problem

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY SURGERY, THREE (3) DISP FIRSTPASS WERE MISFIRING OR BREAKING. THE END BROKE OFF BUT NOT IN THE PATIENT WHEN TRYING TO GET IT TO FIRE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24539901 ↗
• MalfunctionJan 9, 2026Break

  IT WAS REPORTED THAT, DURING A ROTATOR CUFF REPAIR, WHEN SUTURING THE ROTATOR CUFF, THE NEEDLE OF A FIRSTPASS SUTURE PASSER BIT INTO A CALCIFIED AREA AND THE TIP OF NEEDLE WAS BROKEN. THE ROTATOR CUFF IN THE BITTEN AREA WAS AS IT DID NOT SHOW UP ON AN X-RAY, IT WAS DETERMINED THAT THE BROKEN NEEDLE WAS SUBSEQUENTLY REMOVED FROM BODY BY REFLUX, NO METAL FRAGMENTS WERE LEFT INSIDE THE PATIENT. THE PROCEDURE WAS RESUMED, AFTER A 10-MINUTE DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24022842 ↗
• MalfunctionJan 5, 2026Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR, THE NEEDLE OF ONE (1) ENDER NAIL BROKE. THE PROCEDURE WAS PERFORMED USING AN EQUIVALENT S+N BACK-UP. IT IS UNKNOWN IF THERE WAS ANY SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23955899 ↗
• MalfunctionDec 24, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING A SURGERY, THE NEEDLE CAPTURER OF ONE (1) FIRSTPASS SUTURE PASSER DISLOCATED INSIDE THE PATIENT WHILE PASSING THE SUTURE. THE PROCEDURE WAS RESUMED, USING AN EQUIVALENT S+N BACKUP; HOWEVER, IT IS UNKNOWN IF THERE WAS ANY SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23888022 ↗
• MalfunctionDec 19, 2025Break; Break

  IT WAS REPORTED THAT DURING A SHOULDER SURGERY, THE PRIMARY END OF THE FIRST PASS SUTURE PASSER BROKE APART IN THE PATIENT¿S SUBACROMIAL SPACE WHILE EJECTING THE NEEDLE THROUGH THE CUFF TISSUE. ALL BROKEN PIECES WERE REMOVED FROM INSIDE THE PATIENT USING GRASPER GRABBER FORCEPS. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23855337 ↗
• MalfunctionDec 10, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT, DURING A SHOULDER ARTHROSCOPIC PROCEDURE, THE SURGEON WAS NOT ABLE TO LOCK THE FIRSTPASS AND THEN WAS NOT ABLE TO OPEN IT ANYMORE. THE PROCEDURE WAS RESUMED, WITH A DELAY GREATER THAN 30 MIN, USING A CHANGE IN THE SURGICAL TECHNIQUE, IT WAS PERFORMED MANUALLY. PATIENT WAS EXPOSED TO ADDITIONAL ANESTHESIA. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23767658 ↗
• MalfunctionNov 25, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING AN UNSPECIFIED PROCEDURE, THE FIRSTPASS' SUTURE CAPTURER WAS DISLOCATED FROM THE UPPER JAW WHEN PASSING THE SUTURE THROUGH THE PATIENT'S JOINT. THE PROCEDURE WAS RESUMED USING AN EQUIVALENT S+N BACK-UP. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23644401 ↗
• MalfunctionNov 24, 2025Break; Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF ARTHROSCOPY, THE UPPER JAW OF THE FIRSTPASS BROKE AND FELL OFF WHEN THE JAWS WERE CLOSED OUTSIDE THE PATIENT. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACK-UP. ADDITIONAL ANESTHESIA WAS REQUIRED AS CONSEQUENCE OF THE SURGICAL PROLONGATION. THE PATIENT SHOWED FAVORABLE PROGRESS UPON DISCHARGE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23640913 ↗
• MalfunctionOct 24, 2025Retraction Problem; Mechanical Jam; Retraction Problem; Mechanical Jam

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR, THE SURGEON ATTEMPTED TO PASS A SUTURE THROUGH THE CUFF, LOCKED THE JAWS OF THE FIRSTPASS ONTO THE CUFF, THEN PASSED THE SUTURE THROUGH THE CUFF, BUT THE NEEDLE WOULD NOT RETRACT. THE JAW WAS JAMMED CLOSED AROUND THE CUFF, AND A SMALL AMOUNT OF TISSUE WAS TAKEN WHEN THE SURGEON DISLODGED THE DEVICE FROM THE CUFF. THE PATIENT WAS NOT EXPOSED TO ADDITIONAL ANESTHESIA. THE PROCEDURE WAS RESUMED AFTER A NON-SIGNIFICANT SURGICAL DELAY USING AN EQUIVALENT S+N BACKUP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Laceration(s)

  MAUDE report 23384277 ↗
• MalfunctionOct 15, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PROCEDURE, IT WAS NOTICED THAT THE METAL PIECE ON THE FIRSTPASS SUTURE CAPTURE FELL OFF THE DEVICE. THE PROCEDURE WAS RESUMED, USING AN EQUIVALENT S+N BACK-UP. IT IS UNKNOWN IF THERE WAS A DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23280143 ↗
• MalfunctionSep 17, 2025Break; Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR PROCEDURE, THE FIRSTPASS SUTURE PASSER CAPTURE WINDOW WAS BROKEN, AND HALF OF THE CAPTURE WINDOW FELL OFF IN THE BODY AFTER THE FIRSTPASS BIT THE CUFF. ALL THE BROKEN PIECES WERE REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING AN SN BACKUP DEVICE. THERE WAS A DELAY OF 20 MINUTES. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23075456 ↗
• MalfunctionSep 16, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE FIRSTPASS SUTURE PASSER'S UPPER JAW DISLOCATED INSIDE THE PATIENT. IT WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING AN SN BACKUP DEVICE. IT IS UNKNOWN IF THERE WAS A DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23060103 ↗
• MalfunctionSep 8, 2025Break; Difficult to Open or Close; Break; Difficult to Open or Close

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE JAW OF FIRSTPASS COULD NOT CLOSE FULLY AND ENCOUNTER ISSUE TO DEPLOY FOR THE CUFF ¿BITING¿ WITH FEW ATTEMPTS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DELAY OF LESS THAN 30 MINUTES USING A SMITH AND NEPHEW BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22993784 ↗
• MalfunctionAug 26, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY, PART OF THE FIRSTPASS SUTURE PASSER'S JAW BECAME UNDONE INSIDE THE PATIENT'S JOINT AND HAD TO BE RETRIEVED USING A GRASPER. SURGERY WAS COMPLETED WITH A SMITH AND NEPHEW BACK-UP DEVICE INSTEAD. THERE WAS A SURGICAL DELAY OF LESS THAN 30 MINUTES, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22892408 ↗
• MalfunctionAug 25, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE JAWS OF ONE (1) FIRSTPASS SUTURE PASSER CAME OFF THE DEVICE, LEAVING A METAL FRAGMENT ON THE OPERATIVE FIELD. THE BROKEN PIECE WAS FULLY RETRIEVED BY THE SURGEON AT THE TIME OF THE PROCEDURE. IT IS UNKNOWN IF THERE WAS A BACK-UP DEVICE AVAILABLE OR IF THERE WAS A DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22890088 ↗
• MalfunctionAug 6, 2025Break; Break

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPIC PROCEDURE, THE FIRSTPASS FUNCTIONED FOR SEVERAL PASSES WITHOUT COMPLICATION, BUT LATER HAD RESISTANCE WHEN PASSING THE DEVICE. THE SURGEON ATTEMPTED TO PROCEED BUT WAS UNABLE TO COMPLETE THE PASS. THE DEVICE WAS THEN CAREFULLY WITHDRAWN FROM THE JOINT, AND IT WAS DISCOVERED THAT THE CENTRAL CORE OF THE FIRSTPASS DEVICE HAD BROKEN INTO TWO PIECES. ONE HALF OF THE BROKEN PIECE WAS MISSING. AS PRECAUTION, AN INTRAOPERATIVE X-RAY WAS PERFORMED TO ASSESS FOR ANY RETAINED FOREIGN OBJECTS WITHIN THE JOINT, BUT THE IMAGING REVEALED NO VISIBLE REMNANTS LEFT INSIDE THE PATIENT. SURGERY WAS COMPLETED WITH A BACK-UP DEVICE INSTEAD. THERE WAS A SURGICAL DELAY OF LESS THAN 30 MINUTES, AND NO FURTHER COMPLICATIONS WERE REPORTED. PATIENT IS RECOVERING WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22730630 ↗
• MalfunctionAug 4, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE CAPTURE WINDOW OF THE FIRSTPASS SUTURE PASSER BROKE. ALL METAL PARTS WERE REMOVED FROM THE PATIENT. THE SURGERY WAS COMPLETED USING A MYTEK SUTURE GRASPER 60°. THERE WAS NO SURGICAL DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22710194 ↗
• MalfunctionJul 31, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR PROCEDURE, THE TRAP DOOR OF THE FIRSTPASS WAS DISLODGED FROM THE DEVICE WHEN PASSING THROUGH THE ROTATOR CUFF. THE TRAP DOOR WAS RETRIEVED FROM INSIDE THE PATIENT WITH TOOTHED ARTHROSCOPIC GRASPER. THE PROCEDURE WAS COMPLETED WITH A S+N BACK UP DEVICE. THERE WAS A SURGICAL DELAY OF LESS THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22681831 ↗