FIRSTPASS 72290128Recalls & reported problems

Summary

The FDA's MAUDE database contains 232 adverse event reports that list this exact device (DI 00885556694558), received between Nov 12, 2018 and Jun 9, 2026 — classified as 66 injuries, 166 malfunctions.

The most frequently reported specific device problem is “Break” (137 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 232 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 9, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY WITH MENISCAL REPAIR, WHILE INSERTING ONE (1) FIRSTPASS SUTURE PASSER INTO THE JOINT, THE SUTURE CAPTURE MECHANISM WAS DETACHED. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACK-UP. ADDITIONAL ANESTHESIA WAS NOT REQUIRED AS CONSEQUENCE OF THE SURGICAL PROLONGATION. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25443997 ↗
• MalfunctionJun 6, 2026Break

  IT WAS REPORTED THAT DURING A MENISCUS REPAIR PROCEDURE, UPON PUSHING THROUGH THE MENISCAL TISSUE, THE FIRSTPASS MINI DEFLECTED HITTING THE CAPTURE JAWS AND THE CAPTURE JAWS SUBSEQUENTLY SNAPPED OFF INSIDE THE PATIENT. THE BROKEN PARTS WERE RETRIEVED. THE PROCEDURE WAS RESUMED AFTER A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACK UP PRODUCT. ADDITIONAL ANESTHESIA WAS REQUIRED AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25419358 ↗
• MalfunctionJun 1, 2026Break

  IT WAS REPORTED THAT, DURING A SURGERY, WHEN THE FIRSTPASS BITE THE MENISCUS, THE UPPER JAW BROKE. ALL THE METAL FRAGMENTS WERE REMOVED FROM THE BODY THROUGH A SKIN INCISION. BLEEDING OCCURRED AT THE SITE OF THE INCISION. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 25345806 ↗
• MalfunctionMay 21, 2026Break

  IT WAS REPORTED THAT, DURING A KNEE ARTHROSCOPY, THE SUTURE CATCH OF A FIRSTPASS MINI STRAIGHT BROKE INSIDE THE PATIENT¿S KNEE WHILE BACKING OUT THE DEVICE FROM THE JOINT. THE BROKEN PIECE WAS REMOVED WITH AN ARTHROSCOPIC GRASPER. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACK-UP. ADDITIONAL ANESTHESIA WAS NOT REQUIRED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25242652 ↗
• MalfunctionMay 14, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY PROCEDURE, A SMALL METAL COMPONENT OF THE UPPER PART OF THE FIRSTPASS MINI STRAIGHT HAS DISLODGED AND WAS FLOATING INSIDE PATIENT¿S JOINT CAVITY. THAT SMALL METAL PART WAS RETRIEVED AND REMOVED FROM THE PATIENT USING ARTHROSCOPIC GRASPER. NO OTHER PART WAS SEEN IN THE PATIENT¿S JOINT CAVITY, AS CONFIRMED WITH VISUAL INSPECTION OF THE DISLODGED METAL PART AND THE REST OF THE FIRSTPASS MINI DEVICE. THE PROCEDURE WAS RESUMED AFTER A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25175175 ↗
• MalfunctionMay 14, 2026Fracture; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY, THE SUTURE CAPTURE JAW OF A FIRSTPASS MINI BROKE OFF INSIDE THE PATIENT. THE BROKEN PIECE WAS REMOVED WITH THE USE OF X-RAYS AND SURGICAL EXPLORATION. THE PROCEDURE WAS RESUMED, AFTER A DELAY GREATER THAN 30 MINUTES, USING AN EQUIVALENT S+N BACK-UP. ADDITIONAL ANESTHESIA WAS REQUIRED AS CONSEQUENCE OF THE SURGICAL PROLONGATION. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25174414 ↗
• MalfunctionMay 5, 2026Break

  IT WAS REPORTED THAT, DURING AN ACL RECONSTRUCTION, ONE (1) FIRSTPASS MINI SUTURE PASSER WAS NOT CATCHING THE STITCH. WHEN INSPECTING THE TIP OF THE DEVICE, THE "CATCH" PART OF THE TIP WAS MISSING. AFTER, IT WAS NOTICED THAT THE MISSING PIECE WAS ON THE FLOOR. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING A SIMILAR S+N BACK-UP PRODUCT. THERE WAS AN UNEXPECTED EXPOSURE TO X-RAY RADIATION. ADDITIONAL ANESTHESIA WAS NOT REQUIRED AS CONSEQUENCE OF THE SURGICAL PROLONGATION. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25089488 ↗
• MalfunctionApr 26, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING A MENISCAL PROCEDURE, WHILE PASSING THE SUTURE USING THE FIRSTPASS, THE TEETH THAT GRASP THE SUTURE WERE DISENGAGED FROM THE HEAD OF THE DEVICE. IT WAS REPORTED THAT THERE WAS NO DEVICE FRAGMENTATION INSIDE THE PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24993857 ↗
• MalfunctionApr 17, 2026Break; Detachment of Device or Device Component; Material Deformation; Firing Problem

  IT WAS REPORTED THAT DURING A LABRAL REPAIR OF SHOULDER DISLOCATION PROCEDURE, WHILE UTILIZING FIRSTPASS TO PASS A #2 SUTURE THROUGH THE LABRUM AND THE TRIGGER WAS SQUEEZED, THE CAPTURE WINDOW WAS BROKEN AND THE NEEDLE DEPLOYED FROM A POSITION OFFSET FROM THE CENTER. ALL BROKEN PIECES WERE REMOVED FROM THE PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT SN BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24918720 ↗
• MalfunctionApr 14, 2026Break

  IT WAS REPORTED THAT, DURING A MENISCAL REPAIR, THE NEEDLE OF A FIRST PASS MINI BROKE WHILE TAKING THE FIRST BITE. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING THE SAME DEVICE. NO ADDITIONAL ANESTHESIA WAS REQUIRED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24875549 ↗
• MalfunctionApr 10, 2026Break

  IT WAS REPORTED THAT, DURING A PROCEDURE, THE WINDOW OF A FIRSTPASS MINI BROKE OFF. IT IS UNKNOWN HOW THE PROCEDURE WAS PERFORMED OR IF THERE WAS A SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24845733 ↗
• MalfunctionMar 26, 2026Break

  IT WAS REPORTED THAT, DURING A ROTATOR CUFF REPAIR PROCEDURE, THE FIRSTPASS' HINGE BROKE OFF WHEN THE SURGEON TRIED TO PASS THE SUTURE. ALL BROKEN PIECES WERE REMOVED USING TWEEZERS. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24702485 ↗
• MalfunctionMar 23, 2026Break

  IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY, ONE FIRSTPASS MINI STRAIGHT BIT BROKE OFF. ALL OF THE BROKEN PIECES WERE REMOVED FROM PATIENT WITH TWEEZERS. THE PROCEDURE WAS RESUMED, AFTER A NON SIGNIFICANT DELAY, USING AN EQUIVALENT SN BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24662252 ↗
• MalfunctionMar 10, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING A KNEE ARTHROSCOPY, THE WINDOW FROM THE JAWS OF A FIRSTPASS MINI FELL OUT AND DISAPPEARED IN THE KNEE, THEY HAD TO BE SEARCHED FOR A VERY LONG TIME, BUT COULD ULTIMATELY BE RECOVERED. 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. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24559649 ↗
• MalfunctionMar 7, 2026Break; Detachment of Device or Device Component; Material Deformation

  IT WAS REPORTED THAT, DURING AN ACL RECONSTRUCTION PROCEDURE, WHEN THE ARTIFICIAL LIGAMENT WAS PASSED THROUGH THE MENISCUS AND THE TRIGGER OF ONE (1) FIRSTPASS MINI STRAIGHT WAS SQUEEZED AT FIRST TIME, THE CAPTURE WINDOW WAS FRACTURED AND FELL OFF ON THE BODY. THE BROKEN PIECES WERE RETRIEVED FROM THE PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACKUP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24541601 ↗
• MalfunctionMar 5, 2026Break; Failure to Cycle

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY, ONE (1) FIRSTPASS MINI STRAIGHT WAS UNABLE TO CATCH THE TISSUE UPON THE INITIAL DEPLOYMENT ATTEMPT. ON THE SECOND ATTEMPT, THE SUTURE PASSER BROKE. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING A SIMILAR S+N BACK-UP PRODUCT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24527036 ↗
• MalfunctionFeb 25, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING SURGERY, THE THREAD-CATCHING SPRING OF ONE (1) FIRSTPASS MINI STRAIGHT DETACHED FROM THE CLAMP WHILE THE NEEDLE WAS PASSING THROUGH. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24443655 ↗
• MalfunctionFeb 12, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING A MENISCAL ROOT REPAIR, WHEN MOVING A FIRSTPASS MINI IN THE KNEE CONDYLE, THE TOP JAW OF THE SUTURE CATCHMENT CAME LOOSE AND FELL OFF, UPON FALLING OFF, THE SURGEON NOTICED THE METAL PIECE IN THE KNEE, AND RETRIEVED IT WITH GRASPERS. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24324767 ↗
• MalfunctionFeb 5, 2026Break

  IT WAS REPORTED THAT DURING A KNEE PROCEDURE THE STRAIGHT FIRSTPASS TOP PIECE BROKE OFF. THE SURGEON ASKED FOR A FLUOROSCOPY TO ASSIST IN THE RETRIEVAL OF THE METAL PIECE AND WAS ABLE TO REMOVE IT. 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 24272861 ↗
• MalfunctionJan 30, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A KNEE PROCEDURE, THE HATCH OF THE FIRSTPASS SUTURE PASSER FELL OFF. THE PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACKUP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24223607 ↗
• MalfunctionJan 14, 2026Break

  IT WAS REPORTED THAT, DURING AN UNSPECIFIED PROCEDURE, THE NEEDLE OF A FIRSTPASS MINI STRAIGHT (B)(4) WAS BROKEN. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24068039 ↗
• MalfunctionDec 30, 2025Break; Detachment of Device or Device Component; Material Deformation; Break; Detachment of Device or Device Component; Material Deformation

  IT WAS REPORTED THAT, DURING A SURGERY, A FIRSTPASS MINI MADE A STRANGE NOISE AND THE CAPTURE WINDOW WAS BROKEN. ALL BROKEN PIECES WERE REMOVED FROM THE PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, YET IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23923373 ↗
• MalfunctionDec 22, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A SURGERY, WHEN ONE (1) FIRSTPASS MINI STRAIGHT WAS INSERTED INTO THE JOINT AND ACTUATED, THE CAPTURE WINDOW DETACHED INSIDE THE BODY. ALL THE BROKEN PIECES WERE REMOVED FROM THE PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23868411 ↗
• MalfunctionDec 18, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING A ROOT REPAIR, THE JAWS OF A FIRSTPASS MINI FELL OUT AND MIGRATED POSTERIOR. X-RAY WAS BROUGHT IN, AND THE TEETH WERE FOUND AND REMOVED. IT IS UNKNOWN HOW THE PROCEDURE WAS PERFORMED; HOWEVER, THERE WAS A 10-MIN SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23840151 ↗
• MalfunctionDec 11, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING A PROCEDURE, AFTER THE FIRST PASS WAS USED, THE CAPTURE WINDOW FELL OFF FROM THE UPPER JAW. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT SN BACK-UP THERE WAS A RISK OF A PIECE LEFT IN THE BODY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23785178 ↗