V-Loc 180 VLOCA008LRecalls & reported problems

Summary

The FDA's MAUDE database contains 294 adverse event reports that list this exact device (DI 10884521068278), received between Sep 13, 2016 and May 28, 2026 — classified as 142 injuries, 152 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (200 reports).

1 FDA recall record name this device's identifier, 1 still open.

1 other recall cover devices cleared under the same FDA submission (K111442); they may or may not involve this specific model.

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 18, 2026.

Recalls naming this device

1. Sep 28, 2022Class IIOpen, Classified

   Medtronic has received 210 reports of needles breaking during endoscopic suturing. The potential harm(s) include a delay in treatment/therapy, the potential for a portion of the needle to remain in the patient, foreign body reaction, allergic reaction, tissue injury and unintended radiation exposure from additional imaging for both intra-op and postoperative scenarios.

   Z-0200-2023 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 294 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 28, 2026Break

  ACCORDING TO THE REPORTER, THE SUTURING DEVICE CUT THE SUTURE INAPPROPRIATELY, AND SUTURES DID BROKE DURING SUTURING.

  Patient problems: Insufficient Information

  MAUDE report 25315417 ↗
• MalfunctionMay 28, 2026Break

  ACCORDING TO THE REPORTER, THE SUTURING DEVICE CUT THE SUTURE INAPPROPRIATELY, AND SUTURES DID BROKE DURING SUTURING.

  Patient problems: Insufficient Information

  MAUDE report 25315400 ↗
• InjuryMay 7, 2026Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A TOTAL LAPAROSCOPIC HYSTERECTOMY WITH BILATERAL SALPINGECTOMY, THE SUTURE NEEDLE BROKE IN HALF. A SEARCH WAS CONDUCTED FOR THE MISSING NEEDLE FRAGMENT, AND WHEN IT COULD NOT BE LOCATED, IMAGING WAS REQUESTED TO PERFORM AN X-RAY OF THE PATIENT. SHORTLY AFTER THE X-RAY WAS TAKEN, BUT BEFORE IT WAS REVIEWED, THE MISSING PORTION OF THE NEEDLE WAS FOUND IN THE SUCTION CANISTER. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 25112780 ↗
• InjuryMar 19, 2026Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, A LAPAROSCOPIC HYSTERECTOMY WAS UNCOMPLICATED UNTIL CLOSURE. THE VAGINAL CUFF WAS CLOSED USING THE DEVICE. WHEN THE BACK SUTURE WAS PERFORMED TO LOCK THE SUTURE IN PLACE, THE NEEDLE WAS TOGGLED, BECAME EMBEDDED IN TISSUE, AND DISLODGED FROM THE DEVICE. UPON REMOVAL, THE SUTURE BROKE OFF FROM THE NEEDLE, WHICH REMAINED RETAINED IN THE VAGINAL CUFF. MULTIPLE ATTEMPTS WERE MADE TO REMOVE THE NEEDLE VAGINALLY AND LAPAROSCOPICALLY. C-ARM FLUOROSCOPY DEMONSTRATED THE NEEDLE IN SITU NEAR THE LEFT PUBIC RAMUS, RAISING CONCERN THAT THE NEEDLE WAS LOCATED IN THE VAGINAL CUFF. THE NEEDLE WAS UNABLE TO BE PALPATED OR LOCATED IN THE RESECTED TISSUE. A MAGNET WAS USED IN ATTEMPTS TO LOCATE THE NEEDLE LAPAROSCOPICALLY AND VAGINALLY WITHOUT SUCCESS. TISSUE WAS RESECTED; HOWEVER, DUE TO PROXIMITY TO THE BLADDER EDGE AND NEAR A VASCULAR PEDICLE, THE DECISION WAS MADE TO ABANDON FURTHER ATTEMPTS AT REMOVAL AND TO CLOSE THE CUFF.

  Patient problems: Foreign Body In Patient; Unintended Radiation Exposure

  MAUDE report 24638251 ↗
• InjuryMar 10, 2026Break

  ACCORDING TO THE REPORTER, DURING SUTURING OF A VAGINAL CUFF, THE NEEDLE BROKE IN THE TISSUE DURING THE PROCEDURE. IMAGING CONFIRMED THAT A NEEDLE REMNANT WAS RETAINED IN THE TISSUE, AND ATTEMPTS WERE MADE TO RETRIEVE THE RETAINED FRAGMENT BOTH LAPAROSCOPICALLY AND VAGINALLY HOWEVER, THE FRAGMENT COULD NOT BE RECOVERED, AND THE DECISION WAS MADE TO CLOSE THE PROCEDURE.

  Patient problems: Foreign Body In Patient; Unintended Radiation Exposure

  MAUDE report 24554536 ↗
• MalfunctionJan 15, 2026Break

  ACCORDING TO THE REPORTER, WHEN THE SURGEON WAS CLOSING THE SURGICAL CUFF, THE SUTURE BROKE IN HALF, AND WAS FOUND IN THE TISSUE.

  Patient problems: Foreign Body In Patient

  MAUDE report 24079535 ↗
• MalfunctionJan 5, 2026Break; Component or Accessory Incompatibility

  IT WAS REPORTED THAT DURING A TOTAL LAPAROSCOPIC HYSTERECTOMY, THE NEEDLE BROKE IN HALF WHEN LOADING ONTO THE ENDOSTITCH PRIOR TO THE START OF THE CASE, AND THE DEVICE WAS DIFFICULT TO LOAD. A SUTURE FROM ANOTHER MANUFACTURER AND NEEDLE HOLDER WERE USED TO FIX THE ISSUE AND COMPLETE THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23954673 ↗
• MalfunctionDec 26, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC HYSTERECTOMY, THE NEEDLE WAS FALLING OFF. A NEW ENDOSTITCH RELOAD WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23897083 ↗
• MalfunctionDec 26, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC HYSTERECTOMY, THE NEEDLE WAS FALLING OFF. A NEW ENDOSTITCH RELOAD WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23897077 ↗
• MalfunctionDec 11, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC HYSTERECTOMY, DURING THE CLOSING OF THE VAGINAL CUFF, THE NEEDLE WAS FALLING OFF. THE NEEDLE WAS REMOVED AND A NEW RELOAD WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23780782 ↗
• MalfunctionDec 2, 2025Break; Human-Device Interface Problem; Break; Human-Device Interface Problem

  IT WAS REPORTED THAT DURING A TOTAL LAPAROSCOPIC HYSTERECTOMY, SPECIFICALLY WHILE SUTURING THE VAGINAL CUFF, THE NEEDLE BROKE AND A PART OF THE NEEDLE FELL INTO THE CAVITY OF THE PATIENT. THE DEVICE AND THE RELOAD WERE BOTH DIFFICULT TO TOGGLE. THE BROKEN NEEDLE PIECE WAS RETRIEVED WITH A GRASPER, AND THE SAME ISSUE OCCURRED ON THE SECOND INSTRUMENT AND RELOAD. ANOTHER INSTRUMENT AND NEW RELOAD WERE OPENED AND USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23692098 ↗
• MalfunctionDec 2, 2025Break; Human-Device Interface Problem; Break; Human-Device Interface Problem

  IT WAS REPORTED THAT DURING A TOTAL LAPAROSCOPIC HYSTERECTOMY, SPECIFICALLY WHILE SUTURING THE VAGINAL CUFF, THE NEEDLE BROKE AND A PART OF THE NEEDLE FELL INTO THE CAVITY OF THE PATIENT. THE DEVICE AND THE RELOAD WERE BOTH DIFFICULT TO TOGGLE. THE BROKEN NEEDLE PIECE WAS RETRIEVED WITH A GRASPER, AND THE SAME ISSUE OCCURRED ON THE SECOND INSTRUMENT AND RELOAD. ANOTHER INSTRUMENT AND NEW RELOAD WERE OPENED AND USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23692027 ↗
• InjurySep 5, 2025Break; Break

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC HYSTERECTOMY, SPECIFICALLY WHILE CLOSING THE VAGINAL CUFF ON THE SECOND PASS, THE NEEDLE OF THE SUTURE BROKE IN HALF. HALF OF THE BROKEN NEEDLE FELL INTO THE PATIENT'S CAVITY. THE BROKEN HALF OF THE NEEDLE WAS IDENTIFIED OVER FLUOROSCOPY, BUT IT WAS NEVER LOCATED AFTER GRASPING IT IN VIVO. THE SURGICAL TIME WAS EXTENDED BY MORE THAN 30 MINUTES. A NEW DEVICE AND SUTURE WERE OPENED AND USED TO COMPLETE THE CASE.

  Patient problems: Foreign Body In Patient; Unintended Radiation Exposure

  MAUDE report 22980597 ↗
• MalfunctionAug 20, 2025Break; Break

  IT WAS REPORTED THAT DURING THE LAPAROSCOPIC HYSTERECTOMY, WHEN CLOSING THE CUFF, THE NEEDLE BROKE INTO TWO PIECES. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22855982 ↗
• MalfunctionJul 18, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC GYNECOLOGICAL PROCEDURE, A SUTURE FAILED AS IT WAS PASSED THROUGH THE TROCAR. THE SUTURE WAS LOADED INTO THE HANDPIECE, AND CORRECT PLACEMENT AND STABILITY WERE CONFIRMED BY THE SURGICAL TECHNOLOGIST. WHEN THE HANDPIECE WAS INSERTED INTO THE TROCAR AND VISUALIZED LAPAROSCOPICALLY INSIDE THE PATIENT, ONLY THE NEEDLE WAS SEEN, AND THE TAIL OF THE SUTURE HAD DETACHED FROM THE NEEDLE INSIDE THE PATIENT. LAPAROSCOPIC VISUALIZATION CONFIRMED THE POSITION OF THE HANDPIECE TIP AND THE NEEDLE. THE SUTURE WAS REPLACED WITH A NEW ONE TO COMPLETE THE CASE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22543124 ↗
• InjuryJul 9, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER DURING A TOTAL LAPAROSCOPIC HYSTERECTOMY, WHILE SUTURING THE UTERINE CUFF THE NEEDLE BROKE IN HALF. AN X-RAY WAS PERFORMED, AND IT WAS CONFIRMED THAT A VERY SMALL NEEDLE PIECE WAS STILL REMAINING APPROXIMATELY ABOVE THE SYMPHYSIS PUBIS. THE SURGEON WAS ABLE TO RETRIEVE THE FALLEN PIECE.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 22465591 ↗
• MalfunctionJul 9, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER DURING A PROCEDURE, THE NEEDLE BROKE OFF IN PATIENT WHEN ATTEMPTING TO CLOSE THE VAGINAL CUFF.

  Patient problems: Insufficient Information

  MAUDE report 22455105 ↗
• InjuryJun 19, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC HYSTERECTOMY, THE NEEDLE BROKE OFF OF THE ENDOSTITCH DEVICE AND THE NEEDLE COMPONENT FELL INTO THE CAVITY OF THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 22293291 ↗
• InjuryJun 12, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING THE TOTAL LAPAROSCOPIC HYSTERECTOMY BILATERAL SALPINGO-OOPHORECTOMY; WHILE ATTEMPTING TO PERFORM A SUTURE AT THE VAGINAL CUFF, THE NEEDLE LODGED INSIDE THE VAGINAL CUFF TISSUE. UPON THE ATTEMPT TO RETRIEVE THE NEEDLE, THE NEEDLE AND THREAD DETACHED FROM THE METAL ATTACHMENT SITE. THE TIP WAS NOT SEEN ON X-RAY AND SO THE NEEDLE WAS IRRETRIEVABLE FROM THE TISSUE.

  Patient problems: Foreign Body In Patient; Unintended Radiation Exposure

  MAUDE report 22193664 ↗
• InjuryMay 28, 2025Break; Break

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC HYSTERECTOMY PROCEDURE INVOLVING THE SEWING OF THE VAGINAL CUFF, THE FIRST SUTURE THREAD BROKE, AND SUBSEQUENTLY, THE NEEDLE OF THE SECOND SUTURE BROKE WHILE SUTURING. THE BROKEN NEEDLE FELL INTO THE PATIENT CAVITY AND WAS NOT RETRIEVED, NECESSITATING IMAGING TO LOCATE IT. THESE ISSUES RESULTED IN EXTENDED SURGICAL TIME. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE.

  Patient problems: Foreign Body In Patient; Unintended Radiation Exposure

  MAUDE report 22102308 ↗
• InjuryMay 28, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC HYSTERECTOMY PROCEDURE INVOLVING THE SEWING OF THE VAGINAL CUFF, THE FIRST SUTURE THREAD BROKE, AND SUBSEQUENTLY, THE NEEDLE OF THE SECOND SUTURE BROKE WHILE SUTURING. THE BROKEN NEEDLE FELL INTO THE PATIENT CAVITY AND WAS NOT RETRIEVED, NECESSITATING IMAGING TO LOCATE IT. THESE ISSUES RESULTED IN EXTENDED SURGICAL TIME. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE.

  Patient problems: Foreign Body In Patient; Unintended Radiation Exposure

  MAUDE report 22102303 ↗
• MalfunctionApr 28, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC INCISIONAL HERNIA REPAIR WITH MESH, THE NEEDLE SCRAPPED IN HALF WHILE SUTURING INSIDE PATIENT.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21920705 ↗
• InjuryApr 18, 2025Break; Break

  IT WAS REPORTED THAT DURING THE LAPAROSCOPIC VENTRAL HERNIA REPAIR, WHEN CLOSING THE ABDOMINAL WALL, THE SURGEON PASSED THE NEEDLE SUCCESSFULLY THROUGH TISSUE SEVERAL TIMES WITHOUT INCIDENT; THEN THE SURGEON TOOK NEXT BITE OF TISSUE, TOGGLED, AND HALF OF THE NEEDLE (ATTACHED TO STRAND) FELL ASIDE TO THE PATIENT CAVITY, WITH THE OTHER HALF EMBEDDED IN TISSUE. THE SURGEON ATTEMPTED TO LOCATE AND RETRIEVE THE NEEDLE BUT WAS UNSUCCESSFUL AND USED AN ADDITIONAL SUTURE TO COMPLETE THE CLOSURE.

  Patient problems: Foreign Body In Patient

  MAUDE report 21865046 ↗
• MalfunctionApr 2, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC ASSISTED VAGINAL HYSTERECTOMY PROCEDURE FOR THE CLOSURE OF THE VAGINAL CUFF, A COMPONENT OF THE VLOC SUTURE FELL INTO THE CAVITY OF THE PATIENT. THE COMPONENT WAS SUCCESSFULLY RETRIEVED WITH GRASPERS. THE ISSUE WAS RESOLVED BY USING ANOTHER VLOC SUTURE TO COMPLETE THE CASE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21757324 ↗
• MalfunctionMar 27, 2025Break; Break

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE NEEDLE BROKE INSIDE THE PATIENT.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21705246 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K111442. One submission often covers many models, so check the product and lot details in each record.

• Z-0201-2023 · Sep 28, 2022 · Open, Classified
  Endo Stitch V-Loc PBT Non-Absorbable Reload, Models VLOCN004L, VLOCN006L, VLOCN008L, VLOCN204L, VLOCN206L, VLOCN208L, VLOCN304L, VLOCN306L, VLOCN308L