V-Loc 180 VLOCA208LRecalls & reported problems

Summary

The FDA's MAUDE database contains 181 adverse event reports that list this exact device (DI 10884521068285), received between Mar 20, 2017 and Aug 20, 2026 — classified as 86 injuries, 95 malfunctions.

The most frequently reported specific device problem is “Break” (122 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 181 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 20, 2026Break

  According to the reporter, during a laparoscopic gastric bypass, during oversewing the anastomosis, part of the needle broke and fell into the patient cavity. The surgeon was able to retrieved the broken part from the cavity by using a graspers. There was no patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50342919 ↗
• MalfunctionAug 12, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50226927 ↗
• InjuryMay 15, 2026Break

  IT WAS REPORTED THAT, DURING A LAPAROSCOPIC HYSTERECTOMY FOR ABNORMAL UTERINE BLEEDING, A BARBED SUTURE RELOAD WAS BEING USED WHEN CLOSING THE VAGINAL CUFF AND A PORTION OF THE NEEDLE FRACTURED AND FELL INTO THE PATIENT CAVITY. THE NEEDLE FRAGMENT WAS LEFT IN THE PATIENT. THE SURGICAL TIME WAS EXTENDED BY MORE THAN 30 MINUTES DUE TO EXTRA TIME FINDING THE NEEDLE FRAGMENT. AN ADDITIONAL RELOAD WAS USED TO FINISH CLOSURE. PATIENT IS HEALTHY AND HAS RETURNED TO NORMAL ACTIVITY AND FUNCTIONING.

  Patient problems: Foreign Body In Patient

  MAUDE report 25180897 ↗
• InjuryApr 9, 2026Break

  IT WAS REPORTED THAT DURING A TOTAL LAPAROSCOPIC HYSTERECTOMY, WHILE BEING PASSED THROUGH THE VAGINAL CUFF FOR VAGINAL CUFF CLOSURE, THE NEEDLE BROKE. UPON EXITING THE CUFF, THE SURGEON NOTICED ABOUT 4 MM OF THE NEEDLE WAS MISSING. A NEW PRODUCT WAS OPENED TO COMPLETE THE VAGINAL CUFF CLOSURE. THE MISSING PORTION COULD NOT BE LOCATED.

  Patient problems: Foreign Body In Patient

  MAUDE report 24830470 ↗
• MalfunctionMar 25, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING THE TOTAL LAPAROSCOPIC HYSTERECTOMY WHILE CLOSING THE VAGINAL CUFF, THERE WERE NO ISSUES WITH LOADING OR TOGGLING OF THE DEVICE, HOWEVER, WHEN THE SURGEON ATTEMPTED TO TAKE A BITE OF TISSUE, THE NEEDLE FELL OUT OF THE DEVICE. THE ISSUE OCCURRED ON THREE SUTURES. THE NEEDLE COMPONENTS FELL INTO THE CAVITY OF THE PATIENT AND WAS RETRIEVED WITH A GRASPER. A NEW INSTRUMENT AND SUTURE WAS OPENED TO RESOLVE THE ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24693294 ↗
• MalfunctionMar 25, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING THE TOTAL LAPAROSCOPIC HYSTERECTOMY WHILE CLOSING THE VAGINAL CUFF, THERE WERE NO ISSUES WITH LOADING OR TOGGLING OF THE DEVICE, HOWEVER, WHEN THE SURGEON ATTEMPTED TO TAKE A BITE OF TISSUE, THE NEEDLE FELL OUT OF THE DEVICE. THE ISSUE OCCURRED ON THREE SUTURES. THE NEEDLE COMPONENTS FELL INTO THE CAVITY OF THE PATIENT AND WAS RETRIEVED WITH A GRASPER. A NEW INSTRUMENT AND SUTURE WAS OPENED TO RESOLVE THE ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24693194 ↗
• MalfunctionMar 25, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING THE TOTAL LAPAROSCOPIC HYSTERECTOMY WHILE CLOSING THE VAGINAL CUFF, THERE WERE NO ISSUES WITH LOADING OR TOGGLING OF THE DEVICE, HOWEVER, WHEN THE SURGEON ATTEMPTED TO TAKE A BITE OF TISSUE, THE NEEDLE FELL OUT OF THE DEVICE. THE ISSUE OCCURRED ON THREE SUTURES. THE NEEDLE COMPONENTS FELL INTO THE CAVITY OF THE PATIENT AND WAS RETRIEVED WITH A GRASPER. A NEW INSTRUMENT AND SUTURE WAS OPENED TO RESOLVE THE ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24692935 ↗
• InjuryFeb 13, 2026Break; Detachment of Device or Device Component; Human-Device Interface Problem

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC HYSTERECTOMY, WHILE SUTURING THE VAGINAL CUFF, THE NEEDLE SNAPPED IN HALF, WITH ONE HALF REMAINING LODGED IN THE HANDLE AND THE OTHER HALF BREAKING OFF INSIDE THE TISSUE OF THE VAGINAL CUFF. THE HANDLE WAS DESCRIBED AS DIFFICULT TO UNLOAD. THIS RESULTED IN AN INCREASE IN BLEEDING NOT MORE THAN 500CC, INCLUDING EXCESS TISSUE REMOVAL AND ENLARGEMENT OF THE VAGINAL CUFF. THE INCISION WAS EXTENDED BY MORE THAN ONE INCH, AND MORE TISSUE HAD TO BE RESECTED TO LOCATE AND RECOVER THE NEEDLE FRAGMENT LODGED IN THE TISSUE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Laceration(s)

  MAUDE report 24334552 ↗
• InjuryFeb 12, 2026Break

  IT WAS REPORTED THAT DURING SUTURING OF THE VAGINAL CUFF FOLLOWING A LAPAROSCOPIC VAGINAL-ASSISTED HYSTERECTOMY, THE SUTURE NEEDLE BROKE INTO TWO PARTS. THE SURGEON WAS ABLE TO RETRIEVE ONE PORTION OF THE NEEDLE HOWEVER, DESPITE FURTHER EXPLORATION, THE REMAINING FRAGMENT WAS NOT FOUND WITHIN THE SURGICAL FIELD. POSTOPERATIVE X-RAY IMAGING CONFIRMED THE PRESENCE OF THE RETAINED NEEDLE FRAGMENT IN THE ABDOMEN. A DECISION WAS MADE TO LEAVE THE NEEDLE SEGMENT IN SITU, AS IT WAS DETERMINED THAT THERE WAS NO SAFE WAY TO REMOVE IT.

  Patient problems: Foreign Body In Patient; Unintended Radiation Exposure

  MAUDE report 24328897 ↗
• InjuryJan 23, 2026Break

  IT WAS REPORTED THAT DURING A TOTAL LAPAROSCOPIC HYSTERECTOMY, WHILE SUTURING THE VAGINAL CUFF, THE SUTURE BROKE INSIDE OF PATIENT. BROKEN PIECE COULD NOT BE LOCATED AND WAS DETERMINED A RETAINED OBJECT.

  Patient problems: Foreign Body In Patient

  MAUDE report 24168725 ↗
• MalfunctionJan 7, 2026Break

  IT WAS REPORTED THAT DURING A TOTAL LAPAROSCOPIC HYSTERECTOMY, SPECIFICALLY DURING VAGINAL CUFF CLOSURE, THE NEEDLE BROKE, RESULTING IN HALF OF THE NEEDLE FALLING INTO THE CAVITY OF THE PATIENT. BOTH PARTS OF THE BROKEN NEEDLE WERE RETRIEVED FROM THE PATIENT, AND ANOTHER SUTURE WAS USED TO COMPLETE THE VAGINAL CUFF CLOSURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23992607 ↗
• InjuryNov 20, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING THE LAPAROSCOPIC HYSTERECTOMY, THE NEEDLE COMPONENT FELL INTO THE PATIENT CAVITY WHILE SUTURING THE VAGINAL CUFF. THE RETAINED FOREIGN BODY WAS IDENTIFIED, AND X-RAY IMAGING WAS CONDUCTED TO LOCATE THE NEEDLE. AFTER THE IMAGES WERE TAKEN, THE PHYSICIAN DETERMINED THAT THE SAFEST COURSE OF ACTION WAS TO LEAVE THE NEEDLE INSIDE THE CAVITY. THE CASE WAS EXTENDED BY 39 MINUTES AS A RESULT.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 23612526 ↗
• InjuryNov 17, 2025Break; 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 TOTAL LAPAROSCOPIC HYSTERECTOMY WITH BILATERAL SALPINGECTOMY-OOPHORECTOMY, WHILE CLOSING THE VAGINAL CUFF, THE NEEDLE DISLODGED FROM THE JAWS, AND A PORTION OF THE NEEDLE BROKE AND WAS LEFT IN THE PATIENT¿S TISSUE. THE DEVICE COULD NOT BE UNLOADED WITH PRONGS OUT. THE C-ARM WAS BROUGHT TO FIND THE MISSING PIECE. THE PART OF THE TISSUE THAT CONTAINED THE PARTIAL NEEDLE WAS REMOVED, AND THE VAGINAL CUFF WAS RECLOSED. THE SURGICAL TIME WAS EXTENDED BY 40 MINUTES.

  Patient problems: Tissue Breakdown; Unintended Radiation Exposure

  MAUDE report 23570244 ↗
• InjuryNov 3, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A TOTAL LAPAROSCOPIC HYSTERECTOMY, THE SUTURE ATTACHED TO THE NEEDLE SNAPPED OFF WITH THE NEEDLE WHILE THE SURGEON WAS SUTURING THE VAGINAL CUFF AND WAS LEFT INSIDE THE PATIENT. THE BROKEN NEEDLE FRAGMENT WAS UNABLE TO BE RETRIEVED DESPITE THE PHYSICIAN SEARCHING FOR IT. THE LOADING UNIT WAS REPLACED TO RESOLVE THE ISSUE.

  Patient problems: Foreign Body In Patient

  MAUDE report 23452774 ↗
• InjuryJul 8, 2025Break; Break

  IT WAS REPORTED THAT DURING THE LAPAROSCOPIC HYSTERECTOMY, WHILE CLOSING THE VAGINAL CUFF, THE NEEDLE BROKE IN HALF AND FELL INTO THE CAVITY OF THE PATIENT. THE SURGEON ATTEMPTED TO LOOK LAPAROSCOPICALLY ALONG THE VAGINAL CUFF USING A GRASPER TO TRY AND SEE IF THE NEEDLE COULD BE LOCATED. THE NEEDLE WAS NOT LOCATED AND THE PATIENT WAS TAKEN TO THE RECOVERY UNIT WHERE AN X-RAY WAS TAKEN AND THE BROKEN NEEDLE WAS SEEN ON X-RAY. THE BROKEN NEEDLE WAS THEN LEFT INSIDE THE PATIENT. A NEW SUTURE WAS OPENED TO COMPLETE THE CASE. PLI 30 WAS RECEIVED WITHOUT ANY ACCOMPANYING INFORMATION.

  Patient problems: Foreign Body In Patient; Unintended Radiation Exposure

  MAUDE report 22436092 ↗
• MalfunctionJun 18, 2025Detachment of Device or Device Component; Material Twisted/Bent; Detachment of Device or Device Component; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC HYSTERECTOMY, THE NEEDLE FROM THE BARBED SUTURE FELL INTO THE CAVITY OF THE PATIENT AND REQUIRED RETRIEVAL. THE BARB PASSED THROUGH THE INSTRUMENT, EMERGED BENT, AND WAS NOT ATTACHED TO THE SUTURE, WHICH WENT MISSING IN THE PELVIS BUT WAS SUBSEQUENTLY FOUND WITHOUT INCIDENT. ANOTHER SUTURE WAS USED 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 22284456 ↗
• InjuryApr 29, 2025Break; Break

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC HYSTERECTOMY PROCEDURE USING THE RELOAD, PART OF THE NEEDLE TIP SNAPPED OFF AFTER THE FIRST PASS THROUGH THE TISSUE AND FELL INTO THE CAVITY OF THE PATIENT. THE DEVICE WAS BEING APPLIED DURING THE CLOSURE OF THE VAGINAL VAULT. AN X-RAY WAS PERFORMED TO ATTEMPT TO LOCATE THE NEEDLE TIP, BUT IT WAS UNSUCCESSFUL.

  Patient problems: Foreign Body In Patient; Unintended Radiation Exposure

  MAUDE report 21930173 ↗
• MalfunctionApr 24, 2025Break; Break

  IT WAS REPORTED THAT DURING A TOTAL LAPAROSCOPIC HYSTERECTOMY PROCEDURE, THE NEEDLE OF THE ENDOSTITCH DEVICE BROKE OFF DURING USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21900989 ↗
• InjuryApr 18, 2025Break; Break

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC HYSTERECTOMY PROCEDURE, THE DEVICE WAS USED TO CLOSE THE VAGINAL CUFF WHEN THE NEEDLE BROKE IN HALF. THE BROKEN NEEDLE FELL INTO THE CAVITY OF THE PATIENT AND WAS LEFT IN THE PATIENT. AN X-RAY WAS PERFORMED TO LOCATE THE NEEDLE, BUT IT WAS NOT RETRIEVED.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 21868001 ↗
• InjuryApr 4, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A TOTAL LAPAROSCOPIC HYSTERECTOMY USING THE DEVICE, A NEEDLE COMPONENT FELL INTO THE CAVITY OF THE PATIENT AND WAS NOT RETRIEVED. AN X-RAY WAS PERFORMED, WHICH SHOWED THE NEEDLE, BUT IT COULD NOT BE EXTRACTED.

  Patient problems: Foreign Body In Patient; Unintended Radiation Exposure

  MAUDE report 21771102 ↗
• InjuryMar 27, 2025Break; Break

  IT WAS REPORTED THAT DURING A TOTAL LAPAROSCOPIC HYSTERECTOMY B/L SALPINGO-OOPHORECTOMY, THE DEVICE WAS APPLIED DURING THE VAGINAL CUFF CLOSURE STEP OF THE PROCEDURE. DURING THE NEXT TO LAST PASS, THE NEEDLE BROKE WITHIN THE TISSUES. A PORTION REMAINED IN THE DEVICE. A SECOND LOADING UNIT WAS USED TO FULLY CLOSE THE CUFF. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. THE SURGICAL TIME WAS EXTENDED FOR 30 MINUTES OR MORE.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21705189 ↗
• MalfunctionMar 19, 2025Break; Break

  IT WAS REPORTED THAT DURING A TOTAL LAPAROSCOPIC HYSTERECTOMY, THE NEEDLE BROKE IN HALF WHILE ATTEMPTING TO SEW THE VAGINAL CUFF FOR CLOSING. NO COMPONENT FALL INTO THE CAVITY OF THE PATIENT. THE BROKEN NEEDLE WAS SUCCESSFULLY REMOVED USING A GRASPER. NO PATIENT C OMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21643237 ↗
• MalfunctionMar 11, 2025Break; Break

  IT WAS REPORTED THAT DURING A TOTAL LAPAROSCOPIC HYSTERECTOMY, THE NEEDLE BROKE IN HALF WHILE ATTEMPTING TO SEW THE VAGINAL CUFF FOR CLOSING. NO COMPONENT FALL INTO THE CAVITY OF THE PATIENT. THE BROKEN NEEDLE WAS SUCCESSFULLY REMOVED USING A GRASPER. NO PATIENT C OMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21577048 ↗
• InjuryMar 11, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC HYSTERECTOMY PROCEDURE, THE NEEDLE FELL OFF THE SUTURE. AN X-RAY WAS PERFORMED TO LOCATE THE NEEDLE, WHICH WAS FOUND. THE SURGICAL TIME WAS EXTENDED BY 30 MINUTES OR MORE DUE TO THE PRODUCT ISSUE.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 21577038 ↗
• MalfunctionFeb 18, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC ENTERECTOMY PROCEDURE USING THE DEVICE, THE DEVICE WAS APPLIED DURING THE SUTURE OF THE STOMACH AND SMALL BOWEL. THE SUTURE WAS DETACHED FROM THE SUTURE ASSEMBLY. THERE WERE NO COMPLICATIONS SUCH AS TISSUE DAMAGE, BLOOD LOSS, OR EXTENDED SURGICAL TIME. THE ISSUE WAS RESOLVED BY REPLACING THE DEVICE WITH A NEW ONE, AND NO ADDITIONAL OPERATION WAS REQUIRED. THE PATIENT OUTCOME WAS REPORTED AS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21405081 ↗

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