EXPRESSEW 288233Recalls & reported problems

Summary

The FDA's MAUDE database contains 389 adverse event reports that list this exact device (DI 10886705027101), received between Jan 22, 2018 and Sep 16, 2026 — classified as 6 injuries, 383 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (112 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 389 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 16, 2026Break; Device-Device Incompatibility

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50787944 ↗
• MalfunctionJun 10, 2026Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR PROCEDURE THE EXPRESSEW III AC+ GUN DEVICE THE TIP OF THE PRODUCT BROKE (CHIPPED). ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25461673 ↗
• MalfunctionJun 10, 2026Material Deformation

  IT WAS REPORTED THAT DURING AN UNSPECIFIED ARTHROSCOPIC PROCEDURE THE EXPRESSEW III AC+ GUN DEVICE WAS BENT. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25460131 ↗
• MalfunctionJun 2, 2026Mechanical Jam

  IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE EXPRESSEW DEVICE WAS JAMMED/SEIZED. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE WAS CUTTING THE SUTURE WHEN LOADED INTO THE BOTTOM JAW. THERE WERE NO DELAYS IN SURGERY DUE TO THE EVENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25365346 ↗
• MalfunctionMay 29, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, AFTER THE ASSEMBLY OF THE INPUTS (PLATE AND NEEDLE) IT WAS FOUND THAT THE CLAMP WAS IN GOOD CONDITION. HOWEVER, WHEN PASSING THE FIRST POINT IN THE TISSUE, THE CLAMP WAS COMPLETELY DISASSEMBLED IN ITS JAWS. ATTEMPTS WERE MADE TO VERIFY WHETHER IT HAD A SOLUTION, WITHOUT IT BEING POSSIBLE. THE SURGERY WAS PERFORMED SUCCESSFULLY WITH THE USE OF OTHER TWEEZERS THAT COVERED THE NEED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25337489 ↗
• MalfunctionMay 13, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGERY, THAT THE EXPRESSEW DEVICE WAS NOT ALLOWING THE NEEDLE TO FIRE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25159343 ↗
• MalfunctionMay 11, 2026Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT DURING AN UNKNOWN SURGERY WITH AN EXPRESSEW III AC+ GUN, THE EXPRESSEW HINGE WAS PROTRUDING AND DID NOT PASSED THE SUTURE. IT WAS FURTHER REPORTED THAT THE DEVICE WAS DEFORMED/BENT. THERE WAS NO PATIENT CONSEQUENCE, AND THERE WAS NO DELAY IN THE SURGERY. THE EXACT DATE OF THE EVENT WAS UNKNOWN. HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2026. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25142477 ↗
• MalfunctionApr 22, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT DURING AN UNSPECIFIED ARTHROSCOPIC PROCEDURE THAT THE EXPRESSEW III AC+ GUN DEVICE SUTURE PASSER IS GETTING SUTURE CAUGHT AND NOT RELEASING SUTURE FOR PASSING. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24957731 ↗
• MalfunctionApr 20, 2026Difficult to Advance

  IT WAS REPORTED THAT DURING AN UNSPECIFIED ARTHROSCOPIC PROCEDURE THAT THE EXPRESSEW III AC+ GUN DEVICE GOT STUCK WHEN PASSING THROUGH THE STITCH AND DIDN'T GRIP THE TISSUE PROPERLY. THIS DIDN'T AFFECT THE PATIENT, BUT IT DID CAUSE DELAYS IN THE PROCEDURE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24931241 ↗
• MalfunctionApr 16, 2026Break

  IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE THE EXPRESSEW III AC+ GUN DEVICE WAS REPORTED BY SALES REP. THAT THE TOP JAW IS BROKEN. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24899755 ↗
• MalfunctionApr 2, 2026Difficult to Open or Close; Material Deformation

  IT WAS REPORTED THAT DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE EXPRESSEW III AC+ GUN DEVICE WAS DEFORMED/BENT. IT WAS INITIALLY REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS DISCOVERED THAT THE TOP JAW DID NOT CLOSE/FIT PROPERLY ON BOTTOM JAW. THERE WERE NO DELAYS TO THE SURGICAL PROCEDURE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24767906 ↗
• MalfunctionMar 2, 2026Difficult to Open or Close

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR SURGICAL PROCEDURE IT WAS OBSERVED THAT THE JAW OF EXPRESSEW III AC+ GUN AUTO CAPTURE DEVICE WOULD NOT OPEN. IT WAS REPORTED THAT ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. IT WAS REPORTED THAT THERE WAS A 5-MINUTE SURGICAL DELAY. THERE WAS NO ADVERSE PATIENT CONSEQUENCES REPORTED, NOR SURGICAL DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24478816 ↗
• MalfunctionFeb 25, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THAT THE SURGEON USED THE EXPRESSEW III AC+ GUN AS USUAL BUT WAS UNABLE TO CATCH THE THREAD DUE TO POOR BITE ALIGNMENT. IT WAS THOUGHT THAT THERE MAY HAVE BEEN A PROBLEM WITH THE AUTOCAPTURE UNIT ITSELF. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24445687 ↗
• MalfunctionFeb 23, 2026Break

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, WHILE USING THE EXPRESSEW III AC+ GUN DEVICE, IT WAS OBSERVED THAT THE JAW OF THE CLAMP WAS BROKEN. THERE WERE NO REPORTED ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24419633 ↗
• MalfunctionFeb 13, 2026Mechanical Problem; Material Deformation

  IT WAS REPORTED THAT DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE EXPRESSEW III AC+ GUN DEVICE WAS DEFORMED/BENT. IT WAS INITIALLY REPORTED THAT BEFORE A SHOULDER SCOPE SURGERY, THE DEVICE JAWS DID NOT HOLD THE SUTURE TIGHTLY. IT WAS REPORTED THAT THERE WERE NO DELAYS TO THE SURGICAL PROCEDURE AS A SPARE DEVICE WAS AVAILABLE FOR USE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24338090 ↗
• MalfunctionJan 23, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE IT WAS OBSERVED THAT WHEN THE SURGEON USED THE EXPRESSEW III AC+ GUN DEVICE, THE THREAD COULD NOT BE CAUGHT. IT WAS REPORTED THAT EVEN AFTER REPLACING THE PLATE AND NEEDLE, THE THREAD COULD NOT BE CAUGHT. IT WAS REPORTED THAT THERE WERE NO SURGICAL DELAYS AND NO HARM TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24170485 ↗
• MalfunctionJan 8, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR SURGICAL PROCEDURE IT WAS OBSERVED THAT, THE EXPRESSEW III AC+ GUN DEVICE WAS, CATCHING AND WAS UNABLE TO PULL THE SUTURE THROUGH THE ROTATOR CUFF, CAUSING THE SURGEON TO REMOVE THE DEVICE AND START OVER. IT WAS REPORTED THAT ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. IT WAS REPORTED THAT THERE WAS A SLIGHT DELAY IN THE PROCEDURE DUE TO THE EVENT. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24004756 ↗
• MalfunctionDec 24, 2025Device-Device Incompatibility; Mechanical Jam; Device-Device Incompatibility; Mechanical Jam

  IT WAS REPORTED THAT DURING ASSEMBLY OF THE EXPRSEW III AC+ RTN PLATE DEVICE BOARD, THE CLIP GOT STUCK INSIDE IT AND WOULD NOT COME OUT. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23887901 ↗
• MalfunctionDec 15, 2025Break; Break

  IT WAS REPORTED THAT THE EXPRESSEW III AC+ GUN DEVICE SUTURE HINGE WAS BROKEN AND THE SUTURE COULD NOT STICK IN THE BOTTOM JAW. THERE WAS A TWO MINUTE DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23805074 ↗
• MalfunctionDec 10, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE THE EXPRESSEW III AC+ GUN DEVICE TOP JAW IS BENT TO THE RIGHT. THERE WAS NO DELAY TO THE CASE AND NO PATIENT SAFETY ISSUE. THE EXACT DATE OF THIS EVENT WAS UNKNOWN BUT WAS NOTED TO HAVE OCCURRED IN 2025. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23770049 ↗
• MalfunctionNov 11, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THE DURING AN UNSPECIFIED SURGERY, IT WAS OBSERVED THAT THE EXPRESSEW III AC+ GUN DEVICE CLAMP WAS ACTIVATED TO PASS THE STICH HOWEVER THE SUTURE NEEDLE DID NOT EXTEND AND REMAINED STUCK. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23522009 ↗
• MalfunctionNov 6, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH THE EXPRESSEW III AC+ GUN DEVICE. ACCORDING TO THE REPORTER, THE DEVICE JAMMED AND UNUSABLE. IT WAS NOTED THAT THE DEVICE WAS DIFFICULT TO HANDLE FROM THE START, BUT NOT COMPLETELY JAMMED. IT WAS REPORTED THAT THERE WAS A 10 MINUTE DELAY TO THE SURGERY. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23491497 ↗
• MalfunctionOct 30, 2025Break; Break

  IT WAS REPORTED THAT DURING SHOULDER ARTHROSCOPY PROCEDURE, THE EXPRESSEW III AC+ GUN DEVICE HAD THE METAL PIECE ON ITS HEAD BROKEN. IT WAS REPORTED THAT ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. NO SURGICAL DELAY OR PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23430497 ↗
• MalfunctionOct 22, 2025Break; Difficult to Advance; Break; Difficult to Advance

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, DURING THE PASSAGE OF THE STITCHES IN THE TENDON, WHILE USING THE EXPRESSEW III AC+ GUN DEVICE, IT WAS DIFFICULT TO PASS THEM AND ADDITIONALLY THE SUTURE OF THE IMPLANT WAS CUT AND IT WAS NOT RECOVERED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23363449 ↗
• MalfunctionSep 19, 2025Difficult to Advance; Difficult to Advance

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, THE EXPRESSEW III AC+ GUN DEVICE'S NEEDLE FAILED TO RETRACT AFTER BEING DEPLOYED. IT WAS REPORTED THAT THERE WERE NO DELAYS TO THE SURGICAL PROCEDURE AS A SPARE DEVICE WAS AVAILABLE TO COMPLETE THE SURGERY. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS UNKNOWN. HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2025. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23095859 ↗