FirstPass 72290130Recalls & reported problems

Summary

The FDA's MAUDE database contains 80 adverse event reports that list this exact device (DI 00885556694572), received between Jun 17, 2020 and May 11, 2026 — classified as 21 injuries, 59 malfunctions.

The most frequently reported specific device problem is “Break” (39 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 80 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 11, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING A ROOT REPAIR, THE TEETH OF A FIRSTPASS FELL OUT OF THE JAWS AFTER GRASPING AN ULTRATAPE. THE TAPE WAS PASSED AND ENTERED THE TEETH, UPON PULL OUT THE TEETH STAYED ATTACHED TO THE TAPE AT THE ROOT OF THE MENISCUS AND THE REST OF THE FIRSTPASS WAS REMOVED. 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 25145503 ↗
• MalfunctionMay 5, 2026Break

  IT WAS REPORTED THAT DURING A MENISCAL REPAIR PROCEDURE, ONE (1) FIRSTPASS MINI RIGHT BROKE DURING BITING. A FOLLOW-UP MRI WILL BE PERFORMED. THE PROCEDURE WAS RESUMED, AFTER A DELAY GREATER THAN 30 MIN, USING AN ARTHREX COMPETITOR DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 25089579 ↗
• MalfunctionApr 18, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY, A PORTION OF THE TIP OF THE FIRSTPASS BECAME LOOSE. 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 24919767 ↗
• MalfunctionApr 16, 2026Failure to Cycle; Detachment of Device or Device Component; Material Deformation

  IT WAS REPORTED THAT DURING A LEFT KNEE MENISCAL ROOT REPAIR PROCEDURE, IT WAS NOTICED THAT THE FIRSTPASS MINI'S NEEDLE DEFLECTED AND DID NOT CAPTURE THE SUTURE WHEN TO TRY TAKE A BITE OF MENISCUS. THE SELF CAPTURE JAW WAS DISPLACED WHEN REMOVED FROM THE KNEE. THE PROCEDURE WAS RESUMED USING AN EQUIVALENT BACKUP DEVICE, WITHOUT ANY SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24903577 ↗
• MalfunctionApr 5, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING A LABRAL REPAIR OF THE SHOULDER, THE SURGEON INSERTED A FIRSTPASS MINI INTO THE GLENOHUMERAL JOINT SPACE. WHILE ATTEMPTING TO POSITION THE DEVICE AND TAKE A BITE OF TISSUE, THE FIRSTPASS SUTURE TRAP WAS DISLODGED FROM THE HANDLE. THE NEEDLE HAD NOT YET BEEN FIRED. THE PIECE WAS RETRIEVED USING FORCEPS. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING AN ARTHREX SUTURE COMPETITOR DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED. THE PATIENT IS HEALTHY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24787064 ↗
• MalfunctionJan 30, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING A SHOULDER ARTHROSCOPY LABRAL REPAIR, WHILE ATTEMPTING TO PASS MINI TAPE, THE WINDOW OF A FIRSTPASS MINI RIGHT DEVICE FELL OUT. THE PIECE WAS REMOVED WITH A GRASPER. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING A SIMILAR S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED. THE PATIENT'S HEALTH CONDITION IS EXCELLENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24225287 ↗
• MalfunctionJan 26, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING A ROOT REPAIR PROCEDURE, THE SUTURE TRAP OF A FIRTSPASS MINI CAME OUT OF THE TOP JAW IN THE JOINT. ALL THE PIECES WERE REMOVED FROM THE PATIENT USING GRASPERS. THE PROCEDURE WAS RESUMED, AFTER A 30-MIN SURGICAL 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 24181155 ↗
• MalfunctionJan 12, 2026Material Fragmentation

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC SHOULDER STABILIZATION AS THE FIRSTPASS MINI WAS PASSING A MINITAPE THROUGH THE LABRUM IN THE PATIENT¿S LEFT SHOULDER, THE TOP JAW BROKE OFF AND THE FRAGMENT REMAINED INSIDE THE SHOULDER; THE FRAGMENT WAS RETRIEVED USING AN ARTHROSCOPIC GRASPER. THE PROCEDURE WAS COMPLETED WITHOUT PLACING ANY FURTHER ANCHORS. 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 24045793 ↗
• MalfunctionDec 15, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING A LEFT KNEE MENISCAL REPAIR, WHILE USING ONE (1) FIRSTPASS MINI RIGHT, THE CAPTURE JAW WAS HALF DETACHED, CAUSING THE DEVICE NOT BEING ABLE TO CAPTURE THE SUTURE. NO PIECES FELL INTO THE PATIENT. THE PROCEDURE WAS RESUMED, AFTER A NO SIGNIFICANT DELAY, USING A SIMILAR S+N BACK-UP PRODUCT. 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 23804372 ↗
• MalfunctionDec 3, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A MENISCAL ROOT REPAIR SURGERY, A FIRSTPASS MINI FAILED WHEN THE CAGE DETACHED AND FELL INTO THE PATIENT'S JOINT SPACE, REQUIRING RETRIEVAL. ALL THE COMPONENTS WERE RETRIEVED 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 AS CONSEQUENCE OF THE SURGICAL PROLONGATION. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23704970 ↗
• MalfunctionDec 2, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE METAL SELF CAPTURE PIECE OF TWO (2) FIRSTPASS MINI BROKE OFF FROM THE TOP JAM. ONE PIECE FELL INTO THE PATIENT WOUND AND WAS REMOVED VIA ARTHROSCOPIC GRASPER. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN ARTHREX KNEE SCORPION COMPETITOR DEVICE. THE PATIENT STATUS IS FINE AND UNAFFECTED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23696054 ↗
• MalfunctionNov 14, 2025Break; Break

  IT WAS REPORTED THAT, DURING AN ACL & MENISCUS ROOT REPAIR, UPON PASSING THE SUTURE THROUGH THE MENISCUS THE FIRSTPASS MINI BROKE. THE INNER TEETH BROKE OFF AFTER SQUEEZING THE TRIGGER TO CAPTURE THE SUTURE. THE PART WAS PULLED OUT INTACT WITH NO BITS LEFT IN PATIENT, THE NEEDLE WAS ALSO INTACT. THE DEVICE WAS REMOVED WITH ARTHROSCOPIC GRASPER AND ARTERY CLIP. THE PROCEDURE WAS RESUMED, WITH A NON-SIGNIFICANT DELAY, USING A SIMILAR SN BACK-UP. THE PATIENT WAS NOT EXPOSED TO ADDITIONAL ANESTHESIA. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23556945 ↗
• MalfunctionNov 11, 2025Break; Failure to Cycle; Detachment of Device or Device Component; Break; Failure to Cycle; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING A KNEE ARTHROSCOPIC PROCEDURE, AFTER PERFORMING THE SECOND STITCH WITH THE FIRSTPASS MINI, THE THREAD FAILED TO RETURN. THE RACK WAS FOUND TO HAVE BROKEN DURING THE STITCH ATTEMPT AND WHEN ATTEMPTING TO CORRECT THE STITCH OUTSIDE THE PATIENT, THE RACK LOOSENED AND BROKE. 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 23526753 ↗
• MalfunctionOct 23, 2025Detachment of Device or Device Component; Material Deformation; Detachment of Device or Device Component; Material Deformation

  IT WAS REPORTED THAT, DURING A LATERAL MENISCUS POSTERIOR ROOT REPAIR, WHILE PASSING THE MINITAPE (COBRAID BLUE) 39.5 THROUGH THE MENISCUS USING A FIRSTPASS MINI RIGHT, IT WAS NOTICED THAT THE SUTURE CAPTURE CAME OFF FROM THE SUPERIOR JAW OF THE FIRSTPASS MINI RIGHT. THE PART WAS RETRIEVED FROM THE PATIENT USING AN ARTHROSCOPIC GRASPER. THE PROCEDURE WAS PERFORMED 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 23368839 ↗
• MalfunctionOct 19, 2025Break; Break

  IT WAS REPORTED THAT, DURING A MENISCUS REPAIR SURGERY, IT WAS NOTICED THAT THE TRAP'S CATCHING MECHANISM OF ONE (1) FIRSTPASS MINI RIGHT BROKE INSIDE THE PATIENT WHILE ATTEMPTING TO SUTURE THE MENISCUS. THE PROCEDURE WAS RESUMED, AFTER A DELAY GREATER THAN 30 MINS, USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23334033 ↗
• MalfunctionSep 28, 2025Break; Break

  IT WAS REPORTED THAT, DURING A MENISCAL ROOT REPAIR DURING AN ACL OPERATION, IT WAS NOTICED THAT THE FIRSTPASS MINI STRAIGHT UPPER JAW WAS DETACHED WHEN ENTERING THE JOINT. THE DEVICE BROKE INSIDE THE PATIENT, AND THE BROKEN PIECES WERE REMOVED USING TWEEZERS. THE PROCEDURE WAS RESUMED, WITH A DELAY OF LESS THAN 30 MINUTES, USING AN EQUIVALENT SN BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23164082 ↗
• MalfunctionSep 17, 2025Break; Unstable; Break; Unstable

  IT WAS REPORTED THAT, DURING A MENISCAL REPAIR ROOT, IT WAS NOTICED THAT THE FIRSTPASS MINI BROKE, AND THE BODY WAS LOOSE. THE PROCEDURE WAS RESUMED, WITH A DELAY OF LESS THAN 30 MINUTES, USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23073372 ↗
• MalfunctionAug 26, 2025Break; Break

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE CLAW OF THE FIRSTPASS MINI BROKE IN THE PATIENT'S CUFF. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DELAY OF LESS THAN 30 MINUTES. IT IS UNKNOWN IF THERE WAS A BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22901385 ↗
• MalfunctionJul 20, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A LEFT KNEE MENISCAL ROOT REPAIR PROCEDURE, THE SELF-CAPTURE JAW OF THE FIRSTPASS MINI CAME LOOSE AND GOT STUCK IN THE BACK OF THE KNEE AS THE SURGEON TRIED TO FIRE THE ULTRATAPE. THE SURGEON MADE MULTIPLE PUNCTURES WITH A NEEDLE AND EVENTUALLY FOUND AND REMOVED THE METAL. SURGERY WAS COMPLETED USING A BACKUP DEVICE INSTEAD. THERE WAS A SURGICAL DELAY OF MORE THAN 30 MINUTES, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22552591 ↗
• MalfunctionJul 9, 2025Detachment of Device or Device Component; Material Deformation; Detachment of Device or Device Component; Material Deformation

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE FIRSTPASS MINI WAS BEING USED TO PASS MINITAPE THROUGH THE LATERAL MENISCUS. ONCE THE PASSING WAS COMPLETE AND THE SUTURE WAS CAPTURED IN THE SUTURE TRAP, THE SURGEON ATTEMPTED TO REMOVE THE DEVICE FROM THE MEDIAL PORTAL AND THE SUTURE TRAP DISLODGED INTO THE FAT PAD. THE COMPONENT WAS RETRIEVED WITH FORCEPS. THE PROCEDURE WAS COMPLETED USING A SMITH AND NEPHEW BACK UP DEVICE. THERE WAS A DELAY LESS THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22465600 ↗
• MalfunctionJun 30, 2025Break; Failure to Advance; Break; Failure to Advance

  IT WAS REPORTED THAT DURING AN ARHTROSCOPY PROCEDURE, THE FIRSTPASS MINI RIGHT WAS BEING UTILIZED TO PASS SUTURE THROUGH THE MENISCUS. AFTER DEPLOYMENT AND REMOVAL FROM THE PATIENT, IT WAS OBSERVED THAT THE SUTURE WAS NOT PASSED AND CAPTURED PROPERLY. UPON INSPECTION, IT WAS OBSERVED THAT THE CAPTURE PORTION OF THE DEVICE HAD BROKEN LOOSE FROM THE UPPER JAW, BUT STILL PARTIALLY ATTACHED. IN ORDER TO CONFIRM THAT NO PORTION OF THE CAPTURE PIECE WAS LEFT IN THE PATIENT, AN X-RAY WAS TAKEN. NO METAL PRESENT IN THE PATIENT. 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 22355216 ↗
• MalfunctionJun 27, 2025Break; Break

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE CLAMP BITE OF THE FIRSTPASS MINI BROKE IN THE JOINT. 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 22350580 ↗
• MalfunctionMay 31, 2025Detachment of Device or Device Component; Material Deformation; Detachment of Device or Device Component; Material Deformation

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPIC STABILISATION, ON THE 3RD MINITAPE SUTURE USED, THE SUPERIOR JAW OF THE FIRSTPASS CAME OFF. THE JAW WAS RETRIEVED OUTSIDE THE PATIENT, STILL ATTACHED TO THE MINITAPE. 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 22120510 ↗
• MalfunctionMay 9, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROCOPIC LABRUM STABILISATION PROCEDURE, TWO FIRSTPASS LOST THEIR TOP SUTURE CAPTURE JAW WITHIN THE JOINT. ALL PIECES WERE RETRIEVED USING ARTHROSCOPIC GRASPERS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DELAY OF LESS THAN 30 MINUTES USING A COMPETITOR BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21994327 ↗
• MalfunctionMar 28, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPIC SUBCAPULARIS REPAIR, WHEN PASSING THE MINITAPE WITH A FIRSTPASS MINI, THE CAGE FELL OFF THE PASSER AND BECAME LOST IN THE INTRARTICULAR SPACE. THE BROKEN PART WAS REMOVED FROM THE PATIENT. SURGERY WAS COMPLETED WITH A BACK-UP DEVICE, INSTEAD. THERE WAS A DELAY OF 20 MINUTES, AND NO FURTHER COMPLICATIONS WERE REPORTED. PATIENT'S STATUS IS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21720652 ↗