V-Loc 180 VLOCL0615Recalls & reported problems

Summary

The FDA's MAUDE database contains 41 adverse event reports that list this exact device (DI 10884521131163), received between Dec 21, 2017 and Jun 14, 2026 — classified as 5 injuries, 36 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (21 reports).

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

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. Jun 24, 2026Class IIOpen, Classified

   Product may contain a perforation or tear in the sterile barrier packaging. This issue may result in biocontamination of the sterile sutures, which may lead to infection, loss of vision if in ophthalmic utilization, or prolonged surgery.

   Z-2919-2026 · Root cause: Equipment maintenance · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 41 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 14, 2026Break

  IT WAS REPORTED THAT, PRIOR TO HANDLING AFTER OPENING THE PACKAGE, A DETACHED OR DISASSEMBLED LOOP AND A BROKEN LOOP WAS OBSERVED. AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE. NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25497785 ↗
• MalfunctionApr 23, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT PREOPERATIVELY, THE DEVICE HAD A LOOSE SUTURE NEEDLE PRIOR TO USE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24974193 ↗
• MalfunctionApr 21, 2026Break; Detachment of Device or Device Component; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A PROCEDURE, WHILE SUTURING OR PREPARING THE SUTURE AFTER PATIENT INCISION, ON THE SECOND SUTURE, THE NEEDLE BENT, THE NEEDLE DETACHED, AND THE NEEDLE DID NOT FALL INTO THE PATIENT CAVITY. ALSO, WHILE SUTURING, THE SUTURE BROKE IN THE MIDDLE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24941017 ↗
• MalfunctionJan 13, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A ROBOTIC INGUINAL HERNIA PROCEDURE, PRIOR TO THROWING THE FIRST SUTURE, THE NEEDLE DETACHED FROM THE SUTURE. THE NEEDLE FELL INTO THE PATIENT'S ABDOMEN UNDER DIRECT VISUALIZATION. THE NEEDLE WAS RETRIEVED AND REMOVED FROM THE PATIENT'S ABDOMEN, AND NO IMAGING WAS REQUIRED TO LOCATE THE NEEDLE, RESULTING IN EXTENDED SURGICAL TIME. AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24052225 ↗
• MalfunctionDec 12, 2025Break; Break

  IT WAS REPORTED THAT DURING A GYNECOLOGICAL TOTAL HYSTERECTOMY (LAPAROSCOPIC PROCEDURE), THE ABSORBABLE SUTURE THREAD BROKE EIGHT MINUTES INTO THE VAGINAL STUMP SUTURE. THE ISSUE WAS RESOLVED BY USING ANOTHER ABSORBABLE THREAD 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 23788755 ↗
• MalfunctionNov 21, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A ROBOTIC TRANSABDOMINAL RETROMUSCULAR UMBILICAL PROSTHETIC HERNIA REPAIR, WHILE SUTURING TO CLOSE THE FASCIA, THE NEEDLE DETACHED. THE NEEDLE WAS FOUND AND A NEW SUTURE WAS USED TO CLOSE THE FASCIA. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23618504 ↗
• MalfunctionSep 16, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC RADICAL CYSTECTOMY, URETEROCUTANEOSTOMY, BILATERAL URETERAL STENT PLACEMENT, AND LA PAROSCOPIC ADHESIOLYSIS UNDER GENERAL ANESTHESIA, THE LEAD SURGEON PREPARED TO SUTURE AND PLACED A 2-0 (30 CM) BARBED SUTURE ON THE STERILE TABLE, AFTER 4-5 STITCHES, THE NEEDLE AND THREAD WERE DETACHED. THE LEAD SURGEON QUICKLY LOCATED THE NEEDLE UNDER THE SCOPE, REMOVED THE SUTURE AND NEEDLE. A NEW BARBED SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23065205 ↗
• InjuryJun 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, FOLLOWING A VAGINAL PROCEDURE, THE SUTURE WAS USED FOR A VAGINAL STUMP; THE PATIENT HAD DEHISCENCE DUE TO INFECTION. THE PATIENT WAS READMITTED, AND ADDITIONAL SUTURES WERE PERFORMED IN THE VAGINAL AREA TO RESOLVE THE ISSUE.

  Patient problems: Laceration(s); Unspecified Infection

  MAUDE report 22287240 ↗
• InjuryJun 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, ON (B)(6) 2025 A MYOMECTOMY/MYOMA ENUCLEATION WAS PERFORMED; TWO MONTHS LATER, A REOPERATION WAS PERFORMED INSIDE THE VAGINA DUE TO AN INFLAMMATORY RESPONSE ASSOCIATED WITH AN ABNORMAL IMMUNE REACTION RATHER THAN AN INFECTION. THE SMALL INTESTINE WAS ADHERED TO THE EXPOSED SURFACE OF THE SUTURE. AFTER MYOMETRIUM SUTURES, THE SMALL INTESTINE WAS SLOWLY DETACHED WITH A SQUEAK. THE SURGEON MENTIONED THAT IT WAS NOT A BIG PROBLEM BECAUSE IT WAS RECOGNIZED THAT THE CAUSE WAS THAT THE PERITONEAL SUTURE WAS NOT DONE PROPERLY.

  Patient problems: Laceration(s); Unspecified Infection

  MAUDE report 22285138 ↗
• MalfunctionJun 16, 2025Mechanical Problem; Mechanical Problem

  ACCORDING TO THE REPORTER ON POST OPERATIVE LAPAROSCOPIC MYOMECTOMY, WHEN THE INTRAPERITONEAL CAVITY WAS CHECKED USING A SECOND-STAGE LAPAROSCOPY, THERE WAS AN ADHESION OF SMALL INTESTINE DUE TO EXPOSED BARB OF THE BARBED SUTURE. PHYSICIAN BELIEVES THAT THE CAUSE IS THAT THE PERITONEUM SUTURES ARE NOT PROPERLY PLACED. DETACHMENT WAS DONE BY USING FORCEPS AND THERE WERE NO PROBLEMS WITH THE SMALL INTESTINE.

  Patient problems: Adhesion(s)

  MAUDE report 22213662 ↗
• MalfunctionMay 30, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A RIGHT HUMERAL SHAFT SURGERY, THE NEEDLE DETACHED. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22119993 ↗
• InjuryNov 21, 2024Break; Break

  ACCORDING TO THE REPORTER, POST-OPERATIVELY, THE SUTURE BROKE, RESULTING IN A DEHISCENCE. THE PATIENT CAME BACK INTO CLINIC BLEEDING AND SUTURED AT THE CLINIC TO SOLVE ISSUE.

  Patient problems: Wound Dehiscence

  MAUDE report 20745677 ↗
• MalfunctionJul 26, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A RETROGRADE PYELOGRAPHY, WHILE SUTURING, THE NEEDLE DETACHED. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19842326 ↗
• MalfunctionJun 9, 2024Break; Break

  ACCORDING TO THE REPORTER, THE SUTURE THREAD BREAKS AT THE JUNCTION BETWEEN THREAD AND NEEDLE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19495317 ↗
• MalfunctionMar 6, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC ROBOTIC COMPLEX ABDOMINAL WALL RECONSTRUCTION (CAWR) PROCEDURE, AFTER 3 PASSES THROUGH THE HERNIA DEFECT, THE THREAD BROKE. TO RESOLVE THE ISSUE, THE SUTURE WAS TIED OFF, AND A NEW ONE WAS INTRODUCED INTO THE FIELD. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18846892 ↗
• MalfunctionMay 26, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, THE THREAD WAS DETACHED FROM THE NEEDLE UPON RELEASE FROM THE PACKAGE.

  Patient problems: Insufficient Information

  MAUDE report 17015141 ↗
• MalfunctionMar 30, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING THE ROBOTIC LAPAROSCOPIC HYSTERECTOMY, THE NEEDLE POPPED OFF THE SUTURE FOR THE (B)(4) UNITS.

  Patient problems: Insufficient Information

  MAUDE report 16649339 ↗
• MalfunctionMar 23, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING THE ROBOTIC LAPAROSCOPIC HERNIA REPAIR, ON CLOSING SOFT TISSUE FOLLOWING PLACEMENT OF SELF ADHERING MESH, THE FIRST STRAND BROKE MID WAY THROUGH. THE SECOND STRAND, THE NEEDLE BROKE OFF FROM THE SWAGE AT END OF PROCEDURE. THE CASE WAS COMPLETED AND THIRD STRAND WAS NOT NEEDED. ALL PIECES WERE ACCOUNTED FOR WHEN REMOVED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16600557 ↗
• MalfunctionMar 23, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING THE ROBOTIC LAPAROSCOPIC HERNIA REPAIR, ON CLOSING SOFT TISSUE FOLLOWING PLACEMENT OF SELF ADHERING MESH, THE FIRST STRAND BROKE MID WAY THROUGH. THE SECOND STRAND, THE NEEDLE BROKE OFF FROM THE SWAGE AT END OF PROCEDURE. THE CASE WAS COMPLETED AND THIRD STRAND WAS NOT NEEDED. ALL PIECES WERE ACCOUNTED FOR WHEN REMOVED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16600443 ↗
• MalfunctionFeb 17, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE NEEDLE HAS COME OFF THE WIRE INSIDE THE PATIENT'S BELLY. THE SURGEON SEARCHED THE NEEDLE TO RETRIEVED IT.

  Patient problems: Insufficient Information

  MAUDE report 16397167 ↗
• MalfunctionFeb 17, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN OPEN GYNECOLOGIC PROCEDURE, THE NEEDLE DETACHED FROM THE THREAD INSIDE THE PATIENT'S BELLY. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE.

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

  MAUDE report 16396339 ↗
• MalfunctionFeb 16, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC ABDOMINAL WALL RECONSTRUCTION PROCEDURE, VIA A CONTINUOUS SUTURING TECHNIQUE AT THE ABDOMINAL WALL ROOF IN THE RECTUS ABDOMINAL MUSCLE, THE NEEDLE STRIPPED OFF THE WIRE AND IT FELL INTO THE PATIENT'S CAVITY. THE NEEDLE WAS ABLE TO BE RETRIEVED BY THE SURGEON AFTER FALLING INTO THE CAVITY. A NEW SUTURE WITH THE SAME LOT NUMBER WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16386550 ↗
• MalfunctionJan 25, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC SURGERY, WHEN PASSING THE SUTURE THROUGH THE PATIENT'S TISSUE, THE THREAD OF THE TWO SUTURES BROKE. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16240695 ↗
• MalfunctionSep 9, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC GASTRIC SLEEVE, WHILE DOING A CONTINUOUS POINT SUTURING TECHNIQUE SUTURE BROKE WHEN PASSING THROUGH THE TISSUE. A NEW SUTURE WAS USED IN ORDER TO COMPLETE THE CASE. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15397309 ↗
• MalfunctionSep 7, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING AN OPEN PLASTIC SURGERY, WHILE THE NEEDLE WAS PASSING, THE SUTURE BROKE THREE TIMES. THE SUTURE WAS REPLACED TO COMPLETE THE CASE AND RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15372707 ↗