EXPRESSEW 214140Recalls & reported problems

Summary

The FDA's MAUDE database contains 483 adverse event reports that list this exact device (DI 10886705020218), received between Dec 28, 2017 and Sep 16, 2026 — classified as 1 injury, 482 malfunctions.

The most frequently reported specific device problem is “Break” (160 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 483 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 16, 2026Device Slipped; Difficult to Open or Close; Material Deformation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50793411 ↗
• MalfunctionSep 1, 2026Break; Use of Device Problem; Illegible Information

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50550293 ↗
• MalfunctionSep 1, 2026Break; Use of Device Problem; Illegible Information

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50550288 ↗
• MalfunctionMay 22, 2026Difficult to Open or Close; Unintended Movement

  IT WAS REPORTED THAT DURING AN UNSPECIFIED ARTHROSCOPIC PROCEDURE IT WAS OBSERVED THAT THE JAW OF THE EXPRESSEW III W/O HOOK DEVICE WAS NOT CLOSING CORRECTLY AND THE EXPRESSEW II FLEXIBLE SUTURE PASSER -NS DEVICE HAD A BENT JAW CAUSING THE NEEDLE TO NOT DEPLOY. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. DURING IN-HOUSE ENGINEERING EVALUATION IT WAS DETERMINED THAT THE JAW WAS FOUND LOOSE AND IT IS NO POSSIBLE TO CLOSE OR OPEN WHEN PULLING THE TRIGGER. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. THE EXACT DATE OF THE EVENT WAS NOT REPORTED; HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2026. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25256802 ↗
• MalfunctionMay 4, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT THE NEEDLE WAS NOT FIRING RIGHT THROUGH THE EXPRESSEW III W/O HOOK DEVICE. IT WAS NOT REPORTED IF THE DEVICE WAS USED IN SURGERY. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN A SURGICAL PROCEDURE OR IF A SPARE DEVICE WAS AVAILABLE. 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 2026. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25068740 ↗
• MalfunctionApr 29, 2026Material Deformation

  I WAS REPORTED THAT AN EXPRESSEW III W/O HOOK BROKE AND THE TIP WAS BENT. THESE DEVICES WERE USED MULTIPLE TIMES PER WEEK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25035129 ↗
• MalfunctionApr 29, 2026Break; Use of Device Problem; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE DEVICE HAD NO PHYSICAL DAMAGE WHEN RECEIVED, HOWEVER; IT DID NOT FUNCTION AS EXPECTED. DURING IN-HOUSE ENGINEERING EVALUATION IT WAS DETERMINED THAT THE LOWER JAW BROKE AND DETACHED. IT WAS FURTHER DETERMINED THAT THE UPPER JAW WAS DETACHED FROM THE SHAFT, ALSO THE PIN ACTUATOR TO JAW WAS DETACHED. IT WAS NOT REPORTED IF THE DEVICE WAS USED IN A SURGICAL PROCEDURE. THERE WAS NO CONSEQUENCE OR IMPACT TO THE PATIENT, AND NO SIGNS, SYMPTOMS, OR PATIENT INVOLVEMENT WERE IDENTIFIED. THE EXACT DATE OF THE EVENT WAS NOT REPORTED; HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2026. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25029078 ↗
• MalfunctionApr 28, 2026Material Deformation; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING AN UNSPECIFIED ARTHROSCOPIC PROCEDURE THE EXPRESSEW III W/O HOOK DEVICE TIP 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 25022163 ↗
• MalfunctionApr 16, 2026Break

  IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE THAT THE EXPRESSEW III W/O HOOK DEVICE WAS 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 24899823 ↗
• MalfunctionApr 9, 2026Unintended Movement

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR PROCEDURE, IT WAS DISCOVERED THAT THE JAW OF THE EXPRESSEW III W/O HOOK DEVICE MALFUNCTIONED. THE PIN HOLDING THE JAW IN PLACE CAME LOOSE AND WAS COMING OUT OF THE END OF THE EXPRESSEW. 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. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24832857 ↗
• MalfunctionApr 6, 2026Detachment of Device or Device Component; Difficult to Open or Close; Unintended Movement

  IT WAS REPORTED THAT DURING THE PRE-STERILIZATION INSPECTION FOR SURGICAL USE, IT WAS DISCOVERED THAT THE TIP OF THE EXPRESSEW III W/O HOOK DEVICE WAS DAMAGED. IT WAS REPORTED THAT THE BITING PART OF THE TIP WAS LOOSE AND WOBBLY WITH JUST A SLIGHT SHAKE. IT WAS REPORTED THAT THE TIP DOES NOT OPEN OR CLOSE WHEN THE TRIGGER WAS MOVED. THERE WAS NO SURGICAL DELAY AND NO HARM TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24794269 ↗
• MalfunctionMar 25, 2026Break

  IT WAS REPORTED THAT DURING AN UNSPECIFIED ARTHROSCOPIC PROCEDURE THAT AN UNKNOWN IMPLANT DEVICE BROKE. 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 24690698 ↗
• MalfunctionMar 19, 2026Device-Device Incompatibility; Difficult to Open or Close

  IT WAS REPORTED THAT DURING AN UNSPECIFIED ARTHROSCOPY SURGICAL PROCEDURE IT WAS OBSERVED THAT THE EXPRESSEW III W/O HOOK CLAMP DEVICE DID NOT CLOSE PROPERLY AT THE TIP WHICH PREVENTED THE NEEDLE FROM EXTENDING CORRECTLY. IT WAS REPORTED THAT ANOTHER DEVICE WAS USED TO CONTINUE THE PROCEDURE. IT WAS REPORTED THAT THERE WAS A SURGICAL DELAY OF 10 MINUTES DUE TO THE EVENT. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24641544 ↗
• MalfunctionMar 12, 2026Break

  IT WAS NOT REPORTED IF THE DEVICE WAS USED IN SURGERY. THERE WERE FOUR BROKEN EXPRESSEW III W/O HOOK GUNS. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. THE EXACT DATE OF THE EVENT WAS UNKNOWN. HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2026. THIS IS REPORT 4 OF 4 FOR PC-(B)(4)

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24582671 ↗
• MalfunctionMar 12, 2026Break

  IT WAS NOT REPORTED IF THE DEVICE WAS USED IN SURGERY. THERE WERE FOUR BROKEN EXPRESSEW II FLEXIBLE SUTURE PASSER -NS GUNS. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. THE EXACT DATE OF THE EVENT WAS UNKNOWN. HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2026. THIS IS REPORT 3 OF 4 FOR PC-(B)(4)

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24582089 ↗
• MalfunctionMar 12, 2026Break

  IT WAS NOT REPORTED IF THE DEVICE WAS USED IN SURGERY. THERE WERE FOUR BROKEN EXPRESSEW II FLEXIBLE SUTURE PASSER -NS GUNS. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. THE EXACT DATE OF THE EVENT WAS UNKNOWN. HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2026. THIS IS REPORT 2 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24581685 ↗
• MalfunctionMar 11, 2026Break

  IT WAS REPORTED THAT DURING UNKNOWN PROCEDURE, THE EXPRESSEW III W/O HOOK DEVICE HAD TWO EXPRESSEW GUNS BREAK IN THE SAME CASE. 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. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24575889 ↗
• MalfunctionMar 11, 2026Break

  IT WAS REPORTED THAT DURING UNKNOWN PROCEDURE THE EXPRESSEW III W/O HOOK DEVICE HAD TWO EXPRESSEW GUNS BREAK IN THE SAME CASE. 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. THIS IS REPORT 1 OF 2 FOR PC-(B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24570864 ↗
• MalfunctionJan 5, 2026Difficult to Open or Close; Material Twisted/Bent

  IT WAS REPORTED THAT DURING EVALUATION OF THE DEVICE, IT WAS DETERMINED THAT THE EXPRESSEW III W/O HOOK DEVICE WAS DEFORMED/BENT. IT WAS INITIALLY REPORTED THAT THE TOP JAW OF THE DEVICE WOULD NOT OPEN ALL THE WAY. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT. 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 23957973 ↗
• MalfunctionDec 22, 2025Break; Break

  IT WAS REPORTED THAT THE EXPRESSEW III W/HOOK WAS BROKEN POST OPERATIVELY IN STERILE PROCESSING. THERE WERE NO 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 23864313 ↗
• MalfunctionNov 11, 2025Break; Break

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE THE EXPRESSEW III W/O HOOK DEVICE WAS BROKEN. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. 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 23522467 ↗
• MalfunctionNov 6, 2025Break; Break

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE IT WAS OBSERVED THAT THE EXPRESSEW III SUTURE PASSER W/O HOOK DEVICE WAS BROKEN. IT WAS REPORTED THAT ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT HARM OR DELAY IN SURGERY. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23491511 ↗
• MalfunctionOct 21, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS OBSERVED THAT THE EXPRESSEW III W/O HOOK DEVICE HAD FOREIGN MATTER ATTACHED TO THE JAW. IT WAS NOTED IN THE SERVICE ORDER THAT NEEDLE DEVICE WAS STUCK INSIDE AND COULD NOT BE REMOVED. ANOTHER DEVICE WAS USED TO COMPLETE THE 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 23350712 ↗
• MalfunctionAug 26, 2025Break; Break

  IT WAS REPORTED THAT THE EXPRESSEW III W/O HOOK DEVICE HOOK WAS BROKEN. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22894135 ↗
• MalfunctionAug 22, 2025Break; Break

  IT WAS REPORTED THAT THE EXPRESSEW III W/O HOOK DEVICE WAS BROKEN. IT WAS NOT REPORTED IF THE DEVICE WAS USED IN SURGERY. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN A SURGICAL PROCEDURE OR IF A SPARE DEVICE WAS AVAILABLE. 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 22873913 ↗