EXPRESSEW 214141Recalls & reported problems

Summary

The FDA's MAUDE database contains 1,166 adverse event reports that list this exact device (DI 10886705020225), received between Dec 13, 2013 and Sep 14, 2026 — classified as 38 injuries, 1,128 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (696 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 1,166 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 14, 2026Break

  It was reported that during an unspecified arthroscopic procedure, the EXPRESSEW III NEEDLE device, needle 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 50756208 ↗
• MalfunctionSep 8, 2026Device-Device Incompatibility; Material Deformation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50676867 ↗
• MalfunctionJun 11, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR, THE EXPRESSEW III NE WAS USED AS USUAL, BUT THE NEEDLE FAILED TO EMERGE PARTWAY THROUGH THE PROCEDURE, AND THE SUTURE COULD NO LONGER BE CAPTURED. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO SURGICAL DELAY AND NO HARM TO THE PATIENT. THE DEVICE WAS BRAND NEW AND THE FIRST USE WHEN THE ISSUE OCCURRED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25468813 ↗
• 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 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25415080 ↗
• MalfunctionApr 29, 2026Break

  THIS IS REPORT 2 OF 2 OF (B)(4). IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR SURGICAL PROCEDURE IT WAS OBSERVED THAT THE EXPRESSEW III NEEDLE PK5 DEVICE NEEDLE BROKE. THE TENDON SEEMED TO BE VERY HARD AND THE NEEDLE HARDLY WENT THROUGH IT. FINALLY, THE NEEDLE BROKE. WE OPENED A NEW NEEDLE, WHICH BROKE TOO. THE CASED ENDED SUCCESSFULLY, IN MINI-OPENED. THERE WAS A DELAY OF THIRTY MINUTES IN THE PROCEDURE REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 25034314 ↗
• MalfunctionApr 29, 2026Break

  THIS IS REPORT 1 OF 2 (B)(4). IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR SURGICAL PROCEDURE IT WAS OBSERVED THAT THE EXPRESSEW III NEEDLE PK5 DEVICE NEEDLE BROKE. THE TENDON SEEMED TO BE VERY HARD AND THE NEEDLE HARDLY WENT THROUGH IT. FINALLY, THE NEEDLE BROKE. WE OPENED A NEW NEEDLE, WHICH BROKE TOO. THE CASED ENDED SUCCESSFULLY, IN MINI-OPENED. THERE WAS A DELAY OF THIRTY MINUTES IN THE PROCEDURE REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 25031665 ↗
• MalfunctionApr 27, 2026Break

  IT WAS REPORTED THAT DURING AN UNKNOWN SURGERY WITH AN EXPRESSEW III NEEDLE, THE PRODUCT WAS OPENED, AND AFTER SETTING THE NEEDLE, IT BROKE DURING SUTURING. THE BROKEN PIECE WAS REMOVED FROM THE BODY, AND THE OPERATION WAS SUCCESSFULLY COMPLETED WITH A NEW NEEDLE. THERE WERE NO SURGICAL DELAYS AND NO HARM TO THE PATIENT. THE DEVICE WAS BRAND NEW AND THE FIRST USE WHEN THE ISSUE OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25001870 ↗
• MalfunctionMar 23, 2026Use of Device Problem; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS DISCOVERED THAT THE EXPRESSEW III NEEDLE PK5 DEVICE DID NOT DEPLOY. IT WAS REPORTED THAT THE CLAMP WAS CORRECTLY ASSEMBLED FROM ITS THREE COMPONENTS (CLAMP, PLATE, AND NEEDLE) AND PASSED TESTING AT TWO POINTS. WHEN A THREE SHOT WAS MADE, THE NEEDLE DID NOT EMERGE FROM THE TISSUE, AND WHEN IT WAS FINALLY WITHDRAWN, IT WAS EVIDENT THAT THE TIP OF THE NEEDLE WAS NOT INTEGRAL. A REVISION OF THE SURGICAL CAVITY WAS PERFORMED AND THE NEEDLE WAS NOT FOUND. THE OTHER NEEDLE FROM THE SET WAS USED TO COMPLETE THE PROCEDURE. A RADIOGRAPHIC IMAGING WAS OBTAINED WHICH CONFIRMED NO RETAINED FRAGMENTS IN THE JOINT OR SURROUNDING STRUCTURES. THERE WERE NO REPORTS OF INJURIES OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24660468 ↗
• MalfunctionFeb 24, 2026Break

  IT WAS REPORTED THAT DURING UNKNOWN ARTHROSCOPIC PROCEDURE, THE EXPRESSEW III NEEDLE DEVICE NEEDLE TIP BROKE OFF AND COULD NOT BE FOUND. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: Insufficient Information

  MAUDE report 24431522 ↗
• MalfunctionFeb 9, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR FOR CUFF TEAR, THE EXPRESSEW III NEEDLE WAS CORRECTLY ATTACHED TO THE AUTOCAPTURE, AND AFTER THE RETENTION PLATE WAS ATTACHED, THREAD WAS ATTACHED AND AN ATTEMPT WAS MADE TO SUTURE THE ROTATOR CUFF, BUT THE NEEDLE WOULD NOT COME OUT. THIS WAS TRIED SEVERAL TIMES BUT THE THREAD DID NOT CATCH ON THE NEEDLE. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE WITHOUT ANY FURTHER ISSUES. THERE WERE NO SURGICAL DELAY AND NO HARM TO THE PATIENT. THE DEVICE WAS BRAND NEW AND THE FIRST USE WHEN THE ISSUE OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24298326 ↗
• MalfunctionFeb 9, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A ARTHROSCOPIC ROTATOR CUFF REPAIR FOR A TEAR ON SHOULDER, AFTER ATTACHING THE EXPRESSE III NEEDLE DEVICE TO THE AUTO CAPTURE AND CORRECTLY ATTACHING THE RETENTION PLATE, THE SURGEON ATTEMPTED TO THREAD THE ROTATOR CUFF, BUT THE NEEDLE DID NOT COME OUT PROPERLY. THE SURGEON TRIED SEVERAL TIMES, BUT THE SITUATION DID NOT CHANGE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE WITHOUT FURTHER PROBLEMS. THERE WERE NO SURGICAL DELAY AND NO HARM TO THE PATIENT. THE DEVICE WAS BRAND NEW AND THE FIRST USE WHEN THE ISSUE OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24297965 ↗
• MalfunctionFeb 6, 2026Break

  IT WAS REPORTED THAT THE EXPRESSEW III SUTURE NEEDLE DEVICE BROKE DURING USE. THERE WERE NO REPORTS OF SURGICAL DELAY. 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 24278560 ↗
• MalfunctionJan 22, 2026Break

  IT WAS REPORTED THAT DURING ARTHROSCOPIC ROTATOR CUFF REPAIR SURGERY, FOR RIGHT SHOULDER ROTATOR CUFF TORN WITH AUTOCAPTURE, WHEN THREADING THE ROTATOR CUFF ON THE FOURTH ATTEMPT, THE EXPRESSEW III NEEDLE WAS UNABLE TO BE THREADED. UPON INSPECTION, THE DEVICE WAS FOUND TO BE BROKEN. IMAGING CONFIRMED THAT THE TIP OF THE NEEDLE REMAINED INSIDE THE TENDON AROUND THE LOCATION OF THE THIRD THREADING ATTEMPT. USING A COMBINATION OF ARTHROSCOPY AND IMAGING, THE BROKEN NEEDLE WAS DISCOVERED AND REMOVED. A NEWLY OPENED PRODUCT WAS USED. THERE WERE 30 MINUTES OF SURGICAL DELAY AND NO HARM TO THE PATIENT. THE DEVICE WAS BRAND NEW AND THE FIRST USE WHEN THE ISSUE OCCURRED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24146413 ↗
• MalfunctionJan 7, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE IT WAS OBSERVED THAT THE SUTURE NEEDLE SHOT, BUT DID NOT RETURN. THE DATE OF EVENT WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23991086 ↗
• MalfunctionDec 29, 2025Detachment of Device or Device Component; Device-Device Incompatibility; Detachment of Device or Device Component; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE IT WAS OBSERVED THAT WHILE USING THE EXPRSEW III DEVICE, WHEN OPENING THE IMPLANT IT LEAVES WITHOUT THE SLIDING PROTECTOR TO BE ABLE TO ANCHOR IT THROUGH THE SLIDING HOLE OF THE CLAMP. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. 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 23917338 ↗
• MalfunctionNov 10, 2025Break; Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR SURGICAL PROCEDURE IT WAS OBSERVED THAT THE EXPRSEW III DEVICE NEEDLE BROKE OFF WHILE PASSING THE SUTURE THROUGH THE ROTATOR CUFF. THE PROCEDURE WAS WAS COMPLETED SUCCESSFULLY. ONE EXTREMELY SMALL PIECE WAS NOT ABLE TO BE REMOVED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE DATE OF EVENT WAS UNKNOWN BUT WAS KNOWN TO HAVE OCCURRED IN 2025. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 23514240 ↗
• MalfunctionOct 21, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS OBSERVED THAT THE EXPRESSEW III NEEDLE DEVICE NEEDLE TIP WAS BROKEN. IT WAS NOTED IN THE SERVICE ORDER THAT NEEDLE DEVICE WAS STUCK INSIDE THE HOOK DEVICE 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 23350714 ↗
• MalfunctionOct 3, 2025Delivered as Unsterile Product; Packaging Problem; Delivered as Unsterile Product; Packaging Problem

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, WHEN THE SURGEON REQUESTED THE EXPRESSEW III NEEDLE DEVICE IT WAS OBSERVED THAT THE INNER PACKAGING OF THE NEEDLE WAS OPEN. THEREFORE, A NEW NEEDLE WAS OPENED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23213447 ↗
• MalfunctionSep 3, 2025Break; Break

  IT WAS REPORTED THAT DURING A SHOULDER ROTATOR CUFF REPAIR SURGICAL PROCEDURE IT WAS OBSERVED THAT THE EXPRESSEW III NEEDLE DEVICE BROKE AND GENERATED TWO PIECES. THE DEVICE WAS IN USE WITH TWO EXPRESSEW III AC+ GUN DEVICES. THE SURGEON MENTIONED THAT THE GUNS COULD CAPTURE OTHER DEVICES SUCCESSFULLY. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS A TWENTY MINUTE DELAY IN THE PROCEDURE REPORTED. AN X-RAY HAD TO BE DONE TO IDENTIFY THE BROKEN PART BUT IT COULD NOT BE FOUND. THE SURGEON LOOKED FOR THE BROKEN PART ARTHROSCOPICALLY. THE BROKEN PIECE WAS VERY TINY. THE SURGEON WAS NOT AWARE OF ANY CHANGES TO THE PATIENT AFTER THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 22952332 ↗
• MalfunctionAug 26, 2025Difficult to Advance; Difficult to Advance

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGERY; IT WAS OBSERVED THAT THE EXPRESSEW III NEEDLE PK5 DEVICE DID NOT ALLOW TRANSPORT OF THE SUTURE SMOOTHLY THROUGH THE TENDON AND SOMETHING STUCK A BIT. 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 22894047 ↗
• MalfunctionAug 18, 2025Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  REPORT 1 OF 3 FOR (B)(4). IT WAS REPORTED THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR WHILE USING A EXPRESSEW III NEEDLE DEVICE, EXPRSEW III AC+ RTN PLATE DEVICE AND EXPRESSEW III AC+ GUN DEVICE IT WAS OBSERVED THAT THE SURGEON WAS ABLE TO PINCH SUTURES WITH THE RETENTION PLATE BUT WAS UNABLE TO RETRIEVE THEM, AND THEY CAME OFF. ACCORDING TO THE REPORTER, AT FIRST THE SURGEON USED A SUTURE (ORTHOCORD), BUT IT SNAPPED. THE SURGEON KEPT USING THE DEVICES IN QUESTION BUT COULD NOT APPLY SUTURES. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. WHEN THE SALE REP CHECKED THE MOVEMENT OF THE PASSER AFTER THE SURGERY, THE PASSER MOVED WITHOUT ANY PROBLEMS. IT WAS IMPOSSIBLE TO DETERMINE WHETHER THE RETENTION PLATE, THE NEEDLE, OR THE PASSER WAS THE PROBLEM. THERE WAS NO HARM TO THE PATIENT. THERE WAS A THIRTY 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 22825654 ↗
• MalfunctionAug 14, 2025Break; Break

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE FOR RIGHT SHOULDER JOINT RELEASE WITH ROTATOR CUFF REPAIR, ACROMIOPLASTY, AND SYNOVECTOMY IT WAS OBSERVED THAT THE EXPRESSEW III NEEDLE BROKE. IT WAS REPORTED THAT THE BROKEN FOREIGN BODY REMAINED IN THE RIGHT SHOULDER JOINT CAVITY. IT WAS REPORTED THAT DUE TO THE SMALL SIZE OF THE FOREIGN BODY, AND AFTER A LONG SEARCH, NO BROKEN FOREIGN BODY WAS FOUND. IT WAS NOTED IN THE REPORT THAT DUE TO THE SMALL SIZE OF THE BROKEN FOREIGN OBJECT, IT HAD NO SIGNIFICANT IMPACT ON THE HUMAN JOINT. IT WAS REPORTED THAT, AFTER DISCUSSION, THE SEARCH FOR FOREIGN OBJECTS WAS ABANDONED AND THE ROTATOR CUFF TISSUE WAS REPAIRED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. IT WAS REPORTED THAT THERE WAS A TWO-HOUR DELAY IN THE PROCEDURE DUE TO THE EVENT. THERE WERE NO REPORTED ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 22809850 ↗
• MalfunctionAug 14, 2025Break; Break

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE THE EXPRESSEW III NEEDLE DEVICE, WHEN THE SURGEON PASSED THE 13TH SUTURE ON THE ROTATOR CUFF, THE TIP OF THE DEVICE BROKE OFF. THE SURGEON SEARCHED FOR THE BROKEN TIP BUT COULDN¿T. THEREFORE, THE BROKEN FRAGMENT REMAINED IN THE BODY. IMMEDIATELY AFTER THE SURGERY, NO PARTICULAR EFFECTS WERE OBSERVED IN THE PATIENT, BUT CONTINUED FOLLOW-UP WILL BE MAINTAINED. THERE WAS NO SURGICAL DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 22803794 ↗
• MalfunctionAug 14, 2025Break; Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR SURGERY, IT WAS OBSERVED THAT THE EXPRESSEW III NEEDLE PK5 DEVICE NEEDLE TIP WAS BROKEN. ACCORDING TO THE REPORTER, THE BROKEN TIP OF THE DEVICE WAS LOST. 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 22802436 ↗
• MalfunctionAug 12, 2025Break; Break

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE IT WAS OBSERVED THAT THE TIP OF THE EXPRSEW III DEVICE BROKE DURING ROTATOR CUFF SUTURE. IMAGES WERE TAKEN DURING THE PROCEDURE TO CONFIRM THE LOCATION OF THE BREAK. NO REMAINS WERE SUBSEQUENTLY CONFIRMED. THERE WAS NO PROBLEM WITH THE METHOD USED. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. 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 22787556 ↗