V-Loc 180 VLOCA006LRecalls & reported problems

Summary

The FDA's MAUDE database contains 47 adverse event reports that list this exact device (DI 10884521068094), received between Aug 10, 2017 and Sep 23, 2026 — classified as 20 injuries, 27 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (31 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 47 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 23, 2026Detachment of Device or Device Component

  It was reported that during a laparoscopic hysterectomy, the device was used to close the vaginal cuff. One reload was used successfully; however, a second reload could not be loaded properly. A subsequent reload was loaded, and during use, a portion of the needle broke off and fell into the patient¿s abdomen. X-ray imaging performed on (b)(6) 2026, visualized the needle fragment in the abdomen. The physician re-entered the abdomen and attempted to locate the fragment but was unable to find it. The fragment was intentionally left in the patient because the physician determined that conversion to an open procedure to attempt retrieval was not preferable. Surgical time was extended by 30 minutes or more.

  Patient problems: Foreign Body In Patient; Unintended Radiation Exposure

  MAUDE report 50863583 ↗
• InjuryNov 5, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC HERNIA PROCEDURE, A FRAGMENT OF THE RELOAD NEEDLE FELL INTO THE CAVITY OF THE PATIENT AND WAS NOT RETRIEVED. MESH WAS PLACED OVER THE RETAINED NEEDLE FRAGMENT TO COMPLETE THE CASE. AN X-RAY WAS PERFORMED FOR THE EXPRESS PURPOSE OF LOCATING THE RETAINED NEEDLE FRAGMENT. THE SEARCH FOR THE FRAGMENT CAUSED THE CASE TO BE PROLONGED, RESULTING IN EXTENDED PATIENT HOSPITALIZATION. ANOTHER LOADING UNIT WAS USED TO COMPLETE THE CASE.

  Patient problems: Foreign Body In Patient; Unintended Radiation Exposure

  MAUDE report 23473339 ↗
• MalfunctionSep 19, 2025Break; Break

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC HYSTERECTOMY AND LEFT SALPINGECTOMY, THE NEEDLE WAS LOADED INTO THE DEVICE WITHOUT ISSUE AND INSERTED THROUGH THE TROCAR INTO THE PATIENT. UPON PLACING THE DEVICE INSIDE THE PATIENT, IT WAS OBSERVED THAT HALF OF THE NEEDLE WAS MISSING. ONE HALF REMAINED IN THE DEVICE, WHILE THE OTHER HALF HAD FALLEN INTO THE PATIENT¿S CAVITY. THE BROKEN HALF OF THE NEEDLE THAT FELL INTO THE PATIENT WAS SUCCESSFULLY RETRIEVED AND THE REMAINING HALF WAS REMOVED FROM THE DEVICE. A NEW NEEDLE WAS LOADED ONTO THE DEVICE AND THE PROCEDURE CONTINUED WITHOUT FURTHER ISSUES. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23093377 ↗
• InjuryJun 30, 2025Break; Break

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC HYSTERECTOMY, WHILE CLOSING THE VAGINAL CUFF, TWO CONSECUTIVE BARBED SUTURE NEEDLES BROKE IN HALF AND THE BROKEN NEEDLE COMPONENTS FELL INTO THE CAVITY OF THE PATIENT. X-RAY IMAGING WAS PERFORMED TO LOCATE AND CONFIRM RETRIEVAL OF ALL PIECES OF THE BROKEN NEEDLES. THE SURGICAL TIME WAS EXTENDED BY APPROXIMATELY 30-40 MINUTES DUE TO THE NEED TO LOCATE BOTH PIECES. THE PROCEDURE WAS COMPLETED USING LAP NEEDLE DRIVERS AND A CONVENTIONAL BARBED SUTURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unintended Radiation Exposure

  MAUDE report 22355232 ↗
• InjuryJun 30, 2025Break; Break

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC HYSTERECTOMY; WHILE CLOSING THE VAGINAL CUFF, TWO CONSECUTIVE BARBED SUTURE NEEDLES BROKE IN HALF, AND THE BROKEN NEEDLE COMPONENTS FELL INTO THE CAVITY OF THE PATIENT. X-RAY IMAGING WAS PERFORMED TO LOCATE AND CONFIRM RETRIEVAL OF ONE PIECE FROM THE BROKEN NEEDLE. THE SURGICAL TIME WAS EXTENDED BY APPROXIMATELY 30-40 MINUTES DUE TO THE NEED TO LOCATE BOTH PIECES. A LAPAROSCOPIC GRASPER WAS USED TO RETRIEVE THE DISENGAGED PIECES. THE PROCEDURE WAS COMPLETED USING LAP NEEDLE DRIVERS AND A CONVENTIONAL BARBED SUTURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unintended Radiation Exposure

  MAUDE report 22355206 ↗
• MalfunctionDec 30, 2024Detachment of Device or Device Component; Human-Device Interface Problem; Detachment of Device or Device Component; Human-Device Interface Problem

  IT WAS REPORTED THAT DURING A TOTAL LAPAROSCOPIC HYSTERECTOMY, HALF OF THE NEEDLE FELL INTO THE PATIENT'S CAVITY WHILE CLOSING THE VAGINAL CUFF. THE COMPONENT WAS SUCCESSFULLY RETRIEVED WITH A GRASPER. ADDITIONALLY, THE DEVICE WAS DIFFICULT TO UNLOAD. TO RESOLVE THE ISSUE AND COMPLETE THE PROCEDURE, ANOTHER DEVICE WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21035817 ↗
• InjuryNov 1, 2024Detachment of Device or Device Component; Human-Device Interface Problem; Detachment of Device or Device Component; Human-Device Interface Problem

  ACCORDING TO THE REPORTER, DURING A TOTAL LAPAROSCOPIC HYSTERECTOMY, WHEN CLOSING THE VAGINAL CUFF, IT PASSED THROUGH THE ANTERIOR SIDE OF THE CUFF THEN WOULD NOT FLIP TO THE OTHER SIDE TO GO THROUGH THE POSTERIOR EDGE, AND WHEN THE SURGEON PULLED BACK, THE NEEDLE BROKE OFF IN THE VAGINAL CUFF AND THE NEEDLE WAS GONE. THE SURGEON LOOKED FOR THE NEEDLE LAPAROSCOPICALLY AND IN THE VAGINA BUT COULD NOT LOCATE THE NEEDLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 20588814 ↗
• MalfunctionSep 19, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC ASSISTED VAGINAL HYSTERECTOMY PROCEDURE, IN CLOSING THE CUFF ON TWO SUTURES, THE SILVER PART OF THE SUTURE ATTACHED TO THE NEEDLE WOULD BREAK OFF. TO RESOLVE THE ISSUE, ANOTHER TWO SUTURES WERE USED WITH THE SAME INSTRUMENT. THE SURGICAL TIME WAS EXTENDED FOR LESS THAN TEN MINUTES. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20263552 ↗
• MalfunctionSep 19, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC ASSISTED VAGINAL HYSTERECTOMY PROCEDURE, IN CLOSING THE CUFF ON TWO SUTURES, THE SILVER PART OF THE SUTURE ATTACHED TO THE NEEDLE WOULD BREAK OFF. TO RESOLVE THE ISSUE, ANOTHER TWO SUTURES WERE USED WITH THE SAME INSTRUMENT. THE SURGICAL TIME WAS EXTENDED FOR LESS THAN TEN MINUTES. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20259874 ↗
• MalfunctionJun 21, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC VENTRAL HERNIA REPAIR PROCEDURE, WHILE USING THE DEVICE INSIDE THE PATIENT, THE SUTURE NEEDLE BROKE OFF. ALL PIECES APPEAR TO HAVE BEEN RETRIEVED.

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

  MAUDE report 19588757 ↗
• MalfunctionJun 6, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE NEEDLE FROM BOTH DEVICE SEPARATED FROM THE SUTURE PREMATURELY.

  Patient problems: Insufficient Information

  MAUDE report 19479559 ↗
• MalfunctionJun 6, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE NEEDLE FROM BOTH DEVICE SEPARATED FROM THE SUTURE PREMATURELY.

  Patient problems: Insufficient Information

  MAUDE report 19479548 ↗
• MalfunctionSep 27, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC VENTRAL HERNIA, THE SUTURE NEEDLE KEPT SLIPPING OUT OF THE JAWS DESPITE LOADING CORRECTLY. THE STAFF OPENED ANOTHER SUTURING HANDLE AND RELOAD FROM THE SAME LOTS, AND IT WAS DOING THE SAME THING. A NEW LAPAROSCOPIC NEEDLE DRIVER AND SUTURE WERE USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17827387 ↗
• MalfunctionSep 27, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC VENTRAL HERNIA, THE SUTURE NEEDLE KEPT SLIPPING OUT OF THE JAWS DESPITE LOADING CORRECTLY. THE STAFF OPENED ANOTHER SUTURING HANDLE AND RELOAD FROM THE SAME LOTS, AND IT WAS DOING THE SAME THING. A NEW LAPAROSCOPIC NEEDLE DRIVER AND SUTURE WERE USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17827124 ↗
• InjuryMar 28, 2023Detachment of Device or Device Component; Human-Device Interface Problem; Detachment of Device or Device Component; Human-Device Interface Problem

  ACCORDING TO THE REPORTER, DURING A TOTAL LAPAROSCOPIC HYSTERECTOMY, WHEN THE SURGEON WAS CLOSING OF THE VAGINAL CUFF, THE NEEDLE DISLODGED IN THE TISSUE WHILE TAKING A BITE AND THE NEEDLE WAS RETRIEVED BY CUTTING INTO THE SMALL AMOUNT OF TISSUE. IT WAS ALSO NOTED THAT THE DEVICE WAS DIFFICULT TO LOAD. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 16629537 ↗
• MalfunctionFeb 8, 2023Break; Break

  ACCORDING TO THE REPORTER, ON A LAPAROSCOPIC HYSTERECTOMY, WHILE SUTURING THE VAGINAL CUFF, THE FIRST HANDLE AND LOADING UNIT SUTURE THREAD BROKE. ANOTHER LOADING UNIT FROM THE SAME BOX WAS USED. AS THE SURGEON BEGAN TO SUTURE, THE NEEDLE BROKE IN HALF. THE NEEDLE FELL INTO THE PATIENT¿S CAVITY. THE SURGEON HAD TO SEARCH THROUGH THE CAVITY TO FIND THE BEFORE REMOVAL. THE NEEDLE WAS RETRIEVED USING LAPAROSCOPIC GRASPERS. ANOTHER LOADING UNIT WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16330223 ↗
• MalfunctionFeb 8, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, ON A LAPAROSCOPIC HYSTERECTOMY, WHILE SUTURING THE VAGINAL CUFF, THE FIRST HANDLE AND LOADING UNIT SUTURE THREAD BROKE. ANOTHER LOADING UNIT FROM THE SAME BOX WAS USED. AS THE SURGEON BEGAN TO SUTURE, THE NEEDLE BROKE IN HALF. THE NEEDLE FELL INTO THE PATIENT¿S CAVITY. THE SURGEON HAD TO SEARCH THROUGH THE CAVITY TO FIND THE BEFORE REMOVAL. THE NEEDLE WAS RETRIEVED USING LAPAROSCOPIC GRASPERS. ANOTHER LOADING UNIT WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16328078 ↗
• MalfunctionOct 5, 2022Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING THE HYSTERECTOMY PROCEDURE, THE NEEDLE BROKE IN HALF AS A PIECE OF TISSUE WAS GRABBED TOWARDS THE END OF THE STITCHING PROCESS. THE NEEDLE FELL INTO CAVITY AND WAS RETRIEVED QUICKLY BY PULLING THE NEEDLE WITH THE DEVICE. THE PROCEDURE WENT THROUGH AND WAS COMPLETED PROPERLY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15547645 ↗
• MalfunctionOct 5, 2022Break; Detachment of Device or Device Component; Difficult to Open or Close; Break; Detachment of Device or Device Component; Difficult to Open or Close

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC HYSTERECTOMY, AT THE BEGINNING OF THE PROCEDURE, DEVICE WOULD NOT OPEN BACK UP, THE JAWS LOCKED, AND THE SUTURE BROKE INSIDE THE PATIENT, BUT PIECES WERE REMOVED SUCCESSFULLY. A NEW INSTRUMENT WAS PULLED FROM THE SHELF AND USED TO COMPLETE THE CASE AND RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15543787 ↗
• MalfunctionSep 9, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING A HYSTERECTOMY TOTAL LAPAROSCOPIC WITH BILATERAL SALPINGECTOMY, THE NEEDLE BROKE WHILE LOADING THE SUTURE ONTO THE DEVICE. THE SUTURE WAS REMOVED FROM THE TABLE. A NEW NEEDLE WAS USED TO RESOLVE THE ISSUE.

  Patient problems: Insufficient Information

  MAUDE report 15392380 ↗
• InjurySep 8, 2022Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, TOTAL LAPAROSCOPIC HYSTERECTOMY, BILATERAL RETROGARDE, PYELOGRAM, OPEN REIMPLANTATION OF LEFT URETER, LAPAROSCOPIC SALPINGECTOMY, AND LEFT CYSTOSCOPY, WHEN THE SURGEON REMOVED THE SUTURE FROM THE PATIENT, THE SURGEON DISCOVERED THE NEEDLE HAD BROKEN. PART OF THE NEEDLE WAS OBSERVED AND REMOVED. A KIDNEY, URETER, AND BLADDER (KUB) AND PLAIN FILM WAS PERFORMED AFTER THE SURGERY TO IDENTIFY ANY RADIOPAQUE FOREIGN OBJECT. THERE WAS NO EVIDENCE OF ANY RADIOPAQUE FOREIGN OBJECT RETAINED.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 15380133 ↗
• InjuryAug 12, 2022Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING TOTAL LAPAROSCOPIC HYSTERECTOMY, BILATERAL SALPINGO-OOPHORECTOMY AND CYSTOSCOPY, WHEN SURGEON WAS PULLING THE DEVICE THROUGH VAGINAL CUFF, NEEDLE BROKE IN HALF. X-RAY WAS CALLED AND PERFORMED ANTEROPOSTERIOR AND LATERAL VIEW IMAGING. THE SURGEON CONFIRMED REMAINING NEEDLE WAS SHOWN ON X-RAY IMAGE IN VAGINAL CUFF TISSUE. SURGEON LOOKED LAPAROSCOPICALLY INTO ABDOMEN BUT WAS UNABLE TO LOCATE AND REMOVE REMAINING NEEDLE. THE SURGEON DECIDED TO LEAVE NEEDLE IN THE PATIENT.

  Patient problems: Device Embedded In Tissue or Plaque; Foreign Body In Patient; Unintended Radiation Exposure

  MAUDE report 15218090 ↗
• InjuryJul 29, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, ON A TOTAL LAPAROSCOPIC HYSTERECTOMY WITH BILATERAL SALPINGECTOMY, LYSIS OF ADHESION, AND CYSTOSCOPY, THE DEVICE FAILED TO WORK AFTER TWO SUTURES. THE SURGEON FELT THE LOADING UNIT SUTURES WERE POSITIONED WRONG. THE SURGEON CALLED FOR ANOTHER HANDLE AND LOADING UNIT. THE SECOND DEVICE FAILED TO WORK AND ALSO FELT THE LOADING UNIT SUTURES WERE POSITIONED WRONG. THE SURGEON CALLED FOR A THIRD HANDLE AND LOADING UNIT. ON PLACEMENT OF THE FIRST SUTURE, THE TIP OF THE DEVICE BROKE OFF WHILE INSIDE THE VAGINAL CUFF TISSUE. THE SURGEON WAS UNABLE TO SEE THE TIP OF THE DEVICE. X-RAY WAS PERFORMED TO LOCATE THE TIP. ONCE LOCATED, THE VAGINAL TISSUE CONTAINED THE TIP THAT WAS EXCISED. DECISION WAS THEN MADE TO COMPLETE THE CLOSURE VAGINALLY WITH A SUTURE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 15132018 ↗
• MalfunctionJul 8, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING TOTAL LAPAROSCOPIC HYSTERECTOMY WITH BILATERAL SALPINGECTOMY AND CYSTOSCOPY, WHILE CLOSING THE VAGINAL CUFF, THE NEEDLE BROKE IN HALF.

  Patient problems: Insufficient Information

  MAUDE report 14957504 ↗
• InjuryJul 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, TWO WEEKS POSTOPERATIVE TO LAPAROSCOPIC HYSTERECTOMY AND LEFT ADNEXECTOMY, THE PATIENT PRESENTED WITH SEVERE VOMITING AND DIARRHEA - NO IMPROVEMENT WITH CONSERVATIVE MEASURES. 14 DAYS POSTOPERATIVELY, SMALL BOWEL ILEUS CAUSED BY BRIDE OF SUTURE WAS FOUND BY EXPLORATION AND BRIDAL TRANSECTION WAS PERFORMED.

  Patient problems: Diarrhea; Prolapse; Vomiting; Wound Dehiscence

  MAUDE report 14889225 ↗

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