V-Loc 180 VLOCA206LRecalls & reported problems

Summary

The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 10884521068124), received between Apr 6, 2017 and Aug 11, 2026 — classified as 18 injuries, 18 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (25 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 36 reports, in the reporter's own words as published by the FDA.

• InjuryAug 11, 2026Detachment of Device or Device Component

  It was reported that during a total laparoscopic hysterectomy using the suture reload (15 cm), the needle broke as the physician was about to close the incision. The needle fell into the patient cavity. An X-ray was performed to locate the component and confirm that all pieces were retrieved. The physician used surgical scissors to retrieve the needle and completed the procedure by performing a vaginal suture.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 50202389 ↗
• InjuryJun 19, 2026Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC DUODENAL SWITCH, WHILE APPROXIMATING THE SMALL BOWEL, THE SURGEON HAD COMPLETED THE USE OF THE SUTURE, THE DEVICE WORKED COMPLETELY FINE. ONCE THE SURGEON HAD CUT THE SUTURE TO TAKE THE ENDOSTITCH DEVICE OUT OF THE ABDOMEN, THE NEEDLE HAD FALLEN LOSE AND IT WAS LOST IN THE OPERATING ROOM. THE C-ARM WAS BROUGHT INTO THE ROOM TO SEE IF THE NEEDLE COULD BE FOUND INSIDE THE PATIENT¿S ABDOMEN, BUT THE RESULT CAME BACK NEGATIVE. THE SURGICAL TIME WAS EXTENDED BY MORE THAN 30 MINUTES. THE ENDOSTITCH DEVICE WAS USED AGAIN WITH NO ISSUE, BUT THE NEEDLE WAS UNABLE TO BE FOUND.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 25559868 ↗
• MalfunctionAug 22, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A TOTAL LAPAROSCOPIC HYSTERECTOMY (TLH), WHEN THE USER WERE ABOUT TO CLOSE THE INCISION THE NEEDLE BROKE AND FELL INTO THE PATIENT CAVITY. THE SURGEON USED THE SURGICAL SCISSORS AND RETRIEVED THE NEEDLE. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20026830 ↗
• InjuryAug 13, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A TOTAL LAPAROSCOPIC HYSTERECTOMY (TLH) PROCEDURE, WHEN CLOSING THE INCISION, THE NEEDLE BROKE AND FELL INTO THE PATIENT'S CAVITY. AN X-RAY WAS PERFORMED ON THE SAME DAY TO IDENTIFIED THE POSITION OF THE NEEDLE AND THE NEEDLE WAS EXTRACTED WITH A PLIERS.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 19974112 ↗
• MalfunctionMar 5, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC HYSTERECTOMY, WHEN CLOSING THE CUFF, THE NEEDLE REPEATEDLY FELL OUT OF THE INSTRUMENT FOR ALL SIX DEVICE. IT WAS ALSO REPORTED THAT THE NEEDLE FELL INTO THE PATIENT'S CAVITY AND WAS RETRIEVED WITH A GRASPER. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18842113 ↗
• MalfunctionMar 5, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC HYSTERECTOMY, WHEN CLOSING THE CUFF, THE NEEDLE REPEATEDLY FELL OUT OF THE INSTRUMENT FOR ALL SIX DEVICE. IT WAS ALSO REPORTED THAT THE NEEDLE FELL INTO THE PATIENT'S CAVITY AND WAS RETRIEVED WITH A GRASPER. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18841923 ↗
• MalfunctionDec 21, 2022Detachment of Device or Device Component; Human-Device Interface Problem; Detachment of Device or Device Component; Human-Device Interface Problem

  ACCORDING TO THE REPORTER, DURING THE LAPAROSCOPIC HYSTERECTOMY, WHILE ON CUFF CLOSURE, THE DEVICE WAS DIFFICULT TO TOGGLE. IT WAS ALSO STATED THAT THE NEEDLE FELL INTO THE PATIENT CAVITY. THE NEEDLE WAS THEN ABLE TO BE RETRIEVED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16026327 ↗
• MalfunctionAug 11, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC GYNECOLOGICAL PROCEDURE, THE SUTURES BREAK OFF OF THE NEEDLE RIGHT WHERE THE CONNEC TION IS FROM THE NEEDLE SOURCE. THE SURGEON OPENED MORE SUTURES RELOADS TO COMPLETER THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15211007 ↗
• InjuryAug 10, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A TOTAL LAPAROSCOPIC HYSTERECTOMY (TLH) PROCEDURE, WHILE BEING APPLIED ON THE VAGINAL CUFF, THE NEEDLE DETACHED FROM THE THREAD AND THE NEEDLE DISENGAGED INTO THE PATIENT'S CAVITY. THE SURGEON WAS UNABLE TO LOCATE AND RETRIEVE THE NEEDLE. A NEW RELOAD AND HANDLE WERE USED TO RESOLVE THE ISSUE.

  Patient problems: Foreign Body In Patient

  MAUDE report 15201095 ↗
• InjuryAug 4, 2022Break; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Break; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A TOTAL LAPAROSCOPIC HYSTERECTOMY (TLH), IN THE VAGINAL CUFF, THE NEEDLE BROKE AND FELL INTO THE PATIENT'S CAVITY. THE NEEDLE COULD NOT BE REMOVED FROM THE CAVITY. THE OPERATION WAS EXTENDED FOR THIRTY MINUTES AS THE SURGEON TRIED TO FIND THE NEEDLE ON THE PELVIC CAVITY. A NEW RELOAD AND INSTRUMENT WERE USED TO FINISH THE CASE.

  Patient problems: Foreign Body In Patient; Unspecified Tissue Injury

  MAUDE report 15165052 ↗
• InjuryAug 2, 2022Break; Component or Accessory Incompatibility; Detachment of Device or Device Component; Human-Device Interface Problem; Adverse Event Without Identified Device or Use Problem; Break; Component or Accessory Incompatibility; Detachment of Device or Device Component; Human-Device Interface Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC VAGINAL HYSTERECTOMY, IN CLOSING THE VAGINAL CUFF, A PIECE OF THE DEVICE BROKE OFF AND FELL INTO THE PATIENT CAVITY. AN X-RAY WAS PERFORMED TO LOCATE THE FALLEN PIECE. IT WAS ALSO NOTED THAT THE DEVICE WAS DIFFICULT TO TOGGLE, LOAD AND UNLOAD. THE SURGICAL TIME WAS EXTENDED FOR MORE THAN THIRTY MINUTES. ANOTHER HANDLE AND RELOAD WAS USED TO COMPLETE THE CASE.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 15150245 ↗
• MalfunctionJun 28, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC HYSTERECTOMY PROCEDURE, WHILE CLOSING THE VAGINAL CUFF, TWO NEEDLES BROKE IN HALF. A THIRD NEEDLE AND A NEW HANDLE WERE USED TO COMPLETE THE CASE AND RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14845397 ↗
• MalfunctionJun 28, 2022Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE THREE DEVICES WERE BREAKING OFF. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14842121 ↗
• InjuryJun 27, 2022Break; Detachment of Device or Device Component; Human-Device Interface Problem; Adverse Event Without Identified Device or Use Problem; Break; Detachment of Device or Device Component; Human-Device Interface Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A TOTAL LAPAROSCOPIC HYSTERECTOMY, WHILE CLOSING THE VAGINAL CUFF, THE NEEDLE BROKE IN HALF AND PART OF IT WAS LEFT IN THE PATIENT. X-RAY WAS PERFORMED ON (B)(6) 2022 TO LOCATE THE ALL THE PIECES AND THE SURGERY WAS EXTENDED FOR OVER 30 MINUTES. IT WAS ALSO NOTED THAT THE DEVICE WAS DIFFICULT TO TOGGLE. AN ADDITIONAL VLOC SUTURE WAS OPENED IN ORDER TO FINISH CLOSING THE VAGINAL CUFF.

  Patient problems: Foreign Body In Patient; Unintended Radiation Exposure

  MAUDE report 14835866 ↗
• MalfunctionJun 27, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE NEEDLE OF THE DEVICE HAS BROKEN OFF AND FELL INTO THE PATIENT'S CAVITY BUT IT WAS RETRIEVED. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14828934 ↗
• InjuryApr 5, 2022Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC HYSTERECTOMY, WHILE CLOSING THE VAGINAL VAULT, THE NEEDLE BROKE IN THREE PIECES. ONE OF THE THREE PIECES WAS UNABLE TO BE LOCATED DURING SURGERY. THE PATIENT WAS SENT TO RADIOLOGY FOR A CT SCAN, THE BROKEN PIECE HAD BEEN RETAIN INSIDE THE PATIENT. THE PATIENT HAD TO BE TRANSFERRED TO ANOTHER FACILITY FOR FURTHER RADIOLOGY AND PROCEDURE TO HAVE THE ITEM REMOVE. THE SURGICAL TIME WAS EXTENDED BY MORE THAN 30 MINUTES AND THE PATIENT WAS EXPECTED TO HAVE AN EXTENDED HOSPITALIZATION.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 14016033 ↗
• InjuryOct 13, 2021Break; Detachment of Device or Device Component; Human-Device Interface Problem; Break; Detachment of Device or Device Component; Human-Device Interface Problem

  ACCORDING TO THE REPORTER, THE DEVICE WAS DIFFICULT TO TOGGLE DURING VAGINAL CUFF CLOSURE IN TOTAL LAPAROSCOPIC HYSTERECTOMY. A SMALL PORTION OF THE NEEDLE ALSO BROKE OFF AND FELL INTO PATIENT'S CAVITY. AN X-RAY WAS DONE TO THE PATIENT. ANOTHER DEVICE WAS OPENED TO COMPLETE THE CASE.

  Patient problems: Foreign Body In Patient; Unintended Radiation Exposure

  MAUDE report 12628309 ↗
• MalfunctionAug 16, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER DURING LAPAROSCOPICALLY ASSISTED VAGINAL HYSTERECTOMY (LAVH), WHILE SUTURING THE VAGINAL CUFF, THE NEEDLE/SUTURE FELL OFF INTO THE PATIENT CAVITY. THE NEEDLE WAS EASILY RETRIEVED BY THE SURGEON AND COMPLETED THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12324731 ↗
• InjuryAug 11, 2021Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A TRANSVAGINAL HYDROLAPAROSCOPY, ON VAGINAL CUFF CLOSURE, THE NEEDLE BROKE INTO PIECES AND FELL INTO THE PATIENT CAVITY AND WAS RETRIEVED WITH A GRASPER VIA X-RAY. THE SURGICAL TIME WAS EXTENDED BY 30 MINUTES TO ONE HOUR AS THERE WAS A HARD TIME TO FIND THE NEEDLE. THE USER GOT ANOTHER SUTURE AND THE SAME HANDLE WAS USED TO RESOLVE THE ISSUE.

  Patient problems: Unintended Radiation Exposure; Unspecified Tissue Injury

  MAUDE report 12309305 ↗
• InjuryFeb 20, 2020Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, WHILE CLOSING THE CUFF DURING LAPAROSCOPIC HYSTERECTOMY, THE PART OF THE NEEDLE BROKE OFF AND FELL INTO THE PATIENT'S CAVITY. THE SURGEON HAD TO FIND IT WITH X-RAY THEN HAD TO REMOVE IT FROM THE TISSUE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THIS RESULTED TO EXTENDED SURGICAL TIME OF MORE THAN 30 MINUTES.

  Patient problems: No Code Available; Radiation Exposure, Unintended

  MAUDE report 9734029 ↗
• InjuryOct 3, 2019Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC GASTRIC BYPASS PROCEDURE, PART OF THE INSTRUMENTS' NEEDLE BROKE AND FELL INSIDE THE PATIENT. ANOTHER LOADING UNIT AND INSTRUMENT WERE USED TO COMPLETE THE CASE. IT WAS ALSO REPORTED THAT AN X-RAY WAS PERFORMED TO LOCATE THE MISSING NEEDLE, BUT IT WAS NOT FOUND NOR RETRIEVED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Device Embedded In Tissue or Plaque; No Code Available; Radiation Exposure, Unintended; Unintended Radiation Exposure

  MAUDE report 9154344 ↗
• InjuryMay 1, 2019Break; Detachment of Device or Device Component; Human-Device Interface Problem; Break; Detachment of Device or Device Component; Human-Device Interface Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC INGUINAL HERNIA PROCEDURE, THE DEVICE WAS DIFFICULT TO TOGGLE SO THE SURGEONS TRIED TO BEND THE NEEDLE - AND AFTER THE SURGEON HAD BENDED THE NEEDLE THE NEEDLE BROKE IN HALF INSIDE OF THE PATIENT WHILE SUTURING, THE NEEDLE WAS NOT FOUND. THE PATIENT WAS ILLUMINATED SEVERAL TIMES AND THE SURGICAL TIME WAS EXTENDED BY 1 HOUR DUE TO THIS.

  Patient problems: Foreign Body In Patient; No Code Available; No Consequences Or Impact To Patient; Radiation Exposure, Unintended

  MAUDE report 8570129 ↗
• MalfunctionMar 15, 2019Component or Accessory Incompatibility; Detachment of Device or Device Component; Human-Device Interface Problem; Component or Accessory Incompatibility; Detachment of Device or Device Component; Human-Device Interface Problem

  ACCORDING TO THE REPORTER, DURING OVER SEWING OF STAPLE LINE IN A ROUX-EN-Y PROCEDURE, THE DEVICE WAS DIFFICULT TO LOAD AND UNLOAD. THE NEEDLE FELL OUT AS WELL. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8425396 ↗
• InjuryDec 10, 2018Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, ON A LAPAROSCOPIC HYSTERECTOMY, WHILE CLOSING THE VAGINAL CUFF, THE NEEDLE BROKE AND FELL INTO THE PATIENT'S CAVITY. AN X-RAY WAS PERFORMED TWICE TO MAKE SURE THAT BOTH PIECES OF THE BROKEN NEEDLE WERE FOUND WHICH RESULTED TO AN EXTENDED SURGICAL TIME OF MORE THAN 30 MINUTES.

  Patient problems: No Code Available; Radiation Exposure, Unintended

  MAUDE report 8146894 ↗
• MalfunctionNov 26, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, TWO NEEDLES THAT WERE USED BROKE OFF THE SUTURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8101614 ↗

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