EXPRESSEW 214124Recalls & reported problems

Summary

The FDA's MAUDE database contains 224 adverse event reports that list this exact device (DI 10886705003655), received between Mar 6, 2018 and Jul 9, 2026 — classified as 224 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (64 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 224 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 9, 2026Device-Device Incompatibility; Difficult to Open or Close; Unintended Movement

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25766207 ↗
• MalfunctionJun 17, 2026Device Slipped; Device-Device Incompatibility

  IT WAS REPORTED THAT THE EXPRESSEW III W/HOOK DEVICE HAD A FAULTY GRASPING MECHANISM. DURING IN-HOUSE ENGINEERING EVALUATION IT WAS DETERMINED THAT THE UPPER JAW WAS LOOSE. IT WAS NOT REPORTED IF THE DEVICE WAS USED IN A SURGICAL PROCEDURE. IT WAS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES OR PROLONGED HOSPITALIZATION. 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 25533383 ↗
• MalfunctionJun 15, 2026Difficult to Open or Close; Unintended Movement

  IT WAS REPORTED THAT DURING AN UNSPECIFIED ARTHROSCOPIC PROCEDURE THE EXPRESSEW III W/HOOK DEVICE THAT THE JAW OF THE DEPLOYMENT GUN IS LOOSE UPON TRIGGERING. IT DOES NOT CLOSE FLUSH. 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 25510938 ↗
• MalfunctionJun 12, 2026Difficult to Open or Close; Unintended Movement

  IT WAS REPORTED THAT DURING AN UNSPECIFIED ARTHROSCOPIC PROCEDURE THE EXPRESSEW III W/HOOK DEVICE JAWS DID NOT OPEN ON EXPRESSEW AND PART OF THE BARREL WAS DISLODGED. 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 25487920 ↗
• MalfunctionJun 5, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT THE EXPRESSEW III NEEDLE DEVICE WAS GETTING STUCK WITH THE EXPRESSEW III W/HOOK DEVICE WHEN ATTEMPTING TO ADVANCE THE NEEDLE. IT WAS NOT REPORTED IF THE DEVICE WAS USED IN A SURGICAL PROCEDURE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION, OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS NOT REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. NO FURTHER INFORMATION WAS PROVIDED. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25415180 ↗
• MalfunctionApr 30, 2026Break

  IT WAS REPORTED THAT DURING AN UNKNOWN SURGERY WITH AN EXPRESSEW III W/HOOK, THE GUN JAW BROKE OFF IT AND WAS THROWN AWAY. NO PATIENT WAS HARMED WAS REPORTED. THEY USED ANOTHER COMPETITOR AS A REPLACEMENT. THE SOLUTION WAS REPLACING THEIR GUN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25043496 ↗
• MalfunctionMar 16, 2026Difficult to Advance

  IT WAS REPORTED THAT DURING AN UNKNOWN ARTHROSCOPIC PROCEDURE THAT THE EXPRESSEW III W/HOOK DEVICE WOULD NOT ADVANCE THE NEEDLE. 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 24607968 ↗
• MalfunctionFeb 19, 2026Break

  IT WAS REPORTED BY SALES REP VIA EMAIL THAT DURING AN UNKNOWN ARTHROSCOPIC PROCEDURE, THE TIP OF THE EXPRESSEW III W/HOOK, HOOK END BROKE OFF DURING SURGERY. 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 24393156 ↗
• MalfunctionJan 8, 2026Break

  IT WAS REPORTED THAT DURING ROTATOR CUFF REPAIR OPERATION, THE ROTATOR CUFF RAPID SUTURE GUN HAD A FRACTURE IN THE ANTERIOR BITE AREA, RESULTING IN RESIDUAL METAL IN THE PATIENT'S SHOULDER JOINT CAVITY. MEDICAL STAFF IMMEDIATELY REMOVED THE RESIDUAL PART AND PERFORMED C-ARM FLUOROSCOPY ON THE SHOULDER JOINT, WHICH FOUND NO ABNORMAL METAL FOREIGN BODY RESIDUE INSIDE THE BODY. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24006161 ↗
• MalfunctionDec 2, 2025Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE UPPER JAW OF THE EXPRESSEW III W/HOOK DEVICE WAS LOOSE. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE WAS DEFECTIVE. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23694638 ↗
• MalfunctionDec 2, 2025Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE UPPER JAW OF THE EXPRESSEW III W/HOOK DEVICE WAS LOOSE. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE WAS DEFECTIVE. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23694628 ↗
• MalfunctionOct 10, 2025Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR SURGICAL PROCEDURE IT WAS OBSERVED THAT THE EXPRSEW III DEVICE SEEMS TO BE A BIT BENT. IT KEPT SHREDDING THE SUTURES THAT WERE IN A PART OF THE ANCHOR. THERE WERE NO REPORTS OF DELAY TO THE PROCEDURE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23266364 ↗
• MalfunctionOct 6, 2025Break; Break

  IT WAS REPORTED THAT THE EXPRESSEW III W/HOOK WAS BROKEN. THE EVENT OCCURRED IN THE STERILE PROCESSING AREA. THE EVENT WAS NOT RELATED TO 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 23225010 ↗
• MalfunctionJun 6, 2025Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  IT WAS REPORTED THAT THE EXPRESSEW III W/HOOK DEVICE JAW SPRING BROKEN DOES NOT FIRE NEEDLE. SWAPPED OUT E3 GUN. 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 FOR USE. IT WAS NOT REPORTED IF THERE WERE ANY INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22158581 ↗
• MalfunctionMay 16, 2025Break; Break

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS DISCOVERED THAT THE EXPRESSEW III W/HOOK DEVICE BROKE. THERE WAS FIVE-MINUTE DELAY TO THE SURGICAL PROCEDURE. A SPARE DEVICE WAS USED 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 22036510 ↗
• MalfunctionMay 9, 2025Loose or Intermittent Connection; Difficult to Open or Close; Loose or Intermittent Connection; Difficult to Open or Close

  IT WAS REPORTED THAT THE EXPRESSEW III W/HOOK DEVICE JAWS DO NOT CLOSE FLUSH. DURING AN IN HOUSE ENGINEERING EVALUATION IT WAS FOUND THAT THE DEVICE WAS LOOSE. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THIS EVENT WAS UNKNOWN BUT WAS NOTED TO HAVE OCCURRED IN 2025. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21993044 ↗
• MalfunctionMay 7, 2025Break; Break

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE THE EXPRESSEW III W/HOOK DEVICE BROKE DURING USE. ALL OF THE PIECES WERE STILL INTACT AND CAUSED NO PATIENT HARM. 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 21978538 ↗
• MalfunctionMay 1, 2025Use of Device Problem; Difficult to Open or Close; Unintended Movement; Appropriate Device Problem Term/Code Not Available; Use of Device Problem; Difficult to Open or Close; Unintended Movement; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE EXPRESSEW III W/HOOK DEVICE WAS NOT WORKING AND THE CLAW WOULD NOT FULLY CLOSE. IT WAS REPORTED THAT THE DEVICE WAS FULLY INTACT BUT DID NOT FULLY CLAMP DOWN. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE THAT THE UPPER JAW WAS LOOSE. 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 21941931 ↗
• MalfunctionMar 12, 2025Difficult to Open or Close; Unintended Movement; Difficult to Open or Close; Unintended Movement

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE THE EXPRESSEW III W/HOOK DEVICE JAW WILL NOT PROPERLY CLOSE (JAMMED) AND THE SUTURE SNAGGING. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE DEFORMED AND WAS LOOSE. THERE WAS NO PROCEDURE INVOLVED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21583953 ↗
• MalfunctionFeb 10, 2025Break; Break

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE THE EXPRESSEW III W/HOOK DEVICE WAS BROKEN. IT IS UNKNOWN WHETHER 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 21344455 ↗
• MalfunctionJan 28, 2025Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE IT WAS OBSERVED THAT THE TRIGGER OF THE EXPRESSEW III W/HOOK SUTURE PASSER DEVICE DID NOT SEEM TO FIRE THE NEEDLE. IT WAS REPORTED THAT THE INSTRUMENT BROKEN DURING PROCEDURE BUT DID NOT BREAK OFF IN PATIENT. IT WAS REPORTED THAT THE INSTRUMENT WAS FULLY INTACT. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THE EXACT DATE OF THE EVENT WAS NOT REPORTED, HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN JANUARY OF 2025. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21251365 ↗
• MalfunctionDec 10, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR SURGICAL PROCEDURE WHILE USING THE EXPRESSEW III W/HOOK DEVICE, THE SURGEON WAS ATTEMPTING TO PASS SUTURE IN A ROTATOR CUFF TEAR AND THE SUTURE WAS LOADED AND WHEN THE TISSUE WAS GRASPED AND THE TRIGGER PULLED TO DEPLOY, THE SUTURE DID NOT PENETRATE. THE SURGEON NOTICED THE JAWS WERE NOT IN ALIGNMENT WHEN THE DEVICE WAS TAKEN OUT. A SPARE DEVICE WAS USED TO COMPLETE THE PROCEDURE. IT WAS UNKNOWN IF THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS A TWO MINUTE DELAY TO THE PROCEDURE. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO OTHER MEDICAL PROCEDURES WERE REQUIRED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20893777 ↗
• MalfunctionNov 18, 2024Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT DURING AN UNKNOWN SURGICAL PROCEDURE USING THE EXPRESSEW III W/HOOK DEVICE TIP WAS BENT AND UNABLE TO RELEASE SUTURE. THERE WAS NO INCREASE IN THE SURGICAL TIME. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20708994 ↗
• MalfunctionNov 1, 2024Difficult to Open or Close; Material Twisted/Bent; Difficult to Open or Close; Material Twisted/Bent

  IT WAS REPORTED THAT THE EXPRESSEW III W/HOOK WOULD NOT CLOSE FULLY. IT WAS REPORTED THAT THIS EVENT DID NOT FAIL DURING A PROCEDURE. DURING IN-HOUSE ENGINEERING EVALUATION IT WAS DETERMINED THAT THE UPPER JAW WAS BENT. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT OR SURGICAL DELAYS REPORTED. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20587441 ↗
• MalfunctionOct 25, 2024Difficult to Open or Close; Material Deformation; Difficult to Open or Close; Material Deformation

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY PROCEDURE, IT WAS DISCOVERED THAT THE EXPRESSEW III W/HOOK DEVICE WAS NOT PROPERLY GRABBING THE TISSUE AND THE TIP WAS CROOKED/BENT. THE DEVICE WAS WORKING IMPROPERLY. THERE WERE NO DELAYS TO THE SURGICAL PROCEDURE. IT WAS NOT REPORTED IF A SPARE DEVICE WAS AVAILABLE FOR USE. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY..

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20533247 ↗