V-Loc 180 VLOCL0644Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 10884521131262), received between Nov 8, 2017 and Jan 6, 2026 — classified as 3 injuries, 20 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (12 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 6, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A NORMAL SURGICAL PROCEDURE, THE NEEDLE DETACHED FROM THE THREAD UPON REMOVAL FROM THE PACKAGING, RENDERING THE WIRE UNUSABLE. A NEW DEVICE WAS USED 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 23973054 ↗
• MalfunctionJan 6, 2026Break

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC COLORECTAL SURGERY, THE SUTURE THREAD WAS FOUND TO BE BROKEN AFTER OPENING THE PACKAGING. THE BROKEN SUTURE WAS REPLACED WITH A NEW SUTURE 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 23970987 ↗
• MalfunctionDec 24, 2025Break; Break

  IT WAS REPORTED THAT THE LOOP OF THE BARBED SUTURE BROKE DURING USE. A TOTAL OF THREE SUTURES HAD THE ISSUE. NEW SUTURES WERE 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 23891396 ↗
• MalfunctionDec 24, 2025Break; Break

  IT WAS REPORTED THAT THE LOOP OF THE BARBED SUTURE BROKE DURING USE. A TOTAL OF THREE SUTURES HAD THE ISSUE. NEW SUTURES WERE 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 23891393 ↗
• MalfunctionDec 24, 2025Break; Break

  IT WAS REPORTED THAT THE LOOP OF THE BARBED SUTURE BROKE DURING USE. A TOTAL OF THREE SUTURES HAD THE ISSUE. NEW SUTURES WERE 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 23891391 ↗
• InjuryDec 8, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING THE PROCEDURE TO TREAT ACUTE CHOLECYSTITIS, A PATIENT PRESENTED WITH ABDOMINAL PAIN AND NAUSEA AND WAS ADMITTED FOR INTRAVENOUS ANTIBIOTICS AND PLANNED GALLBLADDER REMOVAL. THE GALLBLADDER REMOVAL WAS ABANDONED, AND A DRAIN WAS PLACED INSTEAD. WHILE SUTURING THE GALLBLADDER AROUND THE DRAIN, THE SUTURE DETACHED FROM ITS NEEDLE. THE NEEDLE COULD NOT BE FOUND DESPITE EXPLORATION WITH A CAMERA AND IMAGING. POST-OPERATIVE COMPUTED TOMOGRAPHY SCAN CONFIRMED THE NEEDLE WAS RETAINED IN THE MUSCULAR LAYERS OF THE ABDOMINAL WALL. NO INTERVENTION WAS PLANNED, AND THE PATIENT WAS DISCHARGED WITH FOLLOW-UP.

  Patient problems: Foreign Body In Patient; Unintended Radiation Exposure

  MAUDE report 23752130 ↗
• MalfunctionNov 18, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING A GASTRIC BYPASS, WHILE THE SURGEON WAS PERFORMING THE ENTEROTOMY OF GASTRO-JEJUNUM ANASTOMOSIS, THE TWO SUTURES BROKE. ADDITIONAL NEW SUTURES WERE USED REINFORCE THE SUTURE. THE PROCEDURE WAS EXTENDED FOR ABOUT 30 MINUTES AS A RESULT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23578254 ↗
• MalfunctionNov 17, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING A GASTRIC BYPASS, WHILE THE SURGEON WAS PERFORMING THE ENTEROTOMY OF GASTRO-JEJUNUM ANASTOMOSIS, THE TWO SUTURES BROKE. ADDITIONAL NEW SUTURES WERE USED REINFORCE THE SUTURE. THE PROCEDURE WAS EXTENDED FOR ABOUT 30 MINUTES AS A RESULT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23576383 ↗
• MalfunctionMar 4, 2025Break; Break

  IT WAS REPORTED THAT DURING A ROBOTIC LAPAROSCOPIC PROCEDURE, A SUTURE BROKE WHILE SUTURING. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21521027 ↗
• InjuryOct 18, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, AT THE TIME OF SUTURING, THE NEEDLE WAS DISCARDED AND FELL INTO THE PATIENT'S ABDOMEN. THE SURGEON THEN HAD TO USE THE SHINE AMP TO LOCATE AND REMOVE IT, RESULTING IN THE PATIENT RECEIVING AN UNNECESSARY DOSE OF RADIATION.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 20483489 ↗
• MalfunctionSep 17, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A MYOMECTOMY/ ENDOMETRIOSIS-RELATED PROCEDURE, WHILE SUTURING AFTER THE PATIENT¿S INCISION, THE TWO SUTURE NEEDLES DETACHED AND FELL INTO THE PATIENT¿S CAVITY. BOTH NEEDLES WERE SUCCESSFULLY RETRIEVED. A COMPETITOR'S DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20240008 ↗
• MalfunctionSep 17, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A MYOMECTOMY/ ENDOMETRIOSIS-RELATED PROCEDURE, WHILE SUTURING AFTER THE PATIENT¿S INCISION, THE TWO SUTURE NEEDLES DETACHED AND FELL INTO THE PATIENT¿S CAVITY. BOTH NEEDLES WERE SUCCESSFULLY RETRIEVED. A COMPETITOR'S DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20238037 ↗
• MalfunctionSep 9, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PREOPERATIVELY, THE NEEDLE DETACHED FROM THE THREAD. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20173242 ↗
• InjuryJul 10, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY OF A LAPAROSCOPIC PROCEDURE, WHILE SUTURING, THE LOOP OF THE SUTURE BROKE. ANOTHER SUTURE WAS USED. HOWEVER, ANOTHER SUTURE HAD THE NEEDLE DETACH WHILE SUTURING. THE NEEDLE FELL INTO THE PATIENT¿S CAVITY. A CLIP WAS USED TO RESOLVE THE ISSUE.

  Patient problems: Foreign Body In Patient

  MAUDE report 19710092 ↗
• MalfunctionApr 5, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, THE NEEDLE WAS DISLODGED WHEN THE PACKAGE WAS OPENED. ANOTHER DEVICE WAS USED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19052890 ↗
• MalfunctionApr 4, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY OF A LAPAROSCOPIC PROCEDURE, THE NEEDLE WAS DISLODGED WHEN THE PACKAGE WAS OPENED. ANOTHER DEVICE WAS USED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: Insufficient Information

  MAUDE report 19043766 ↗
• MalfunctionJan 17, 2024Difficult to Open or Close; Difficult to Open or Close

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC HERNIOPLASTY, DURING SUTURING, THE DOCTOR INDICATED THAT DURING THE USE OF THE DEVICE, THE BARBED SUTURE DID NOT ANCHOR TO THE TISSUE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18531722 ↗
• MalfunctionDec 9, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, THE NEEDLE BROKE FROM STRAND. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15954229 ↗
• MalfunctionJun 24, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY TO A LAPAROSCOPIC GASTRIC BYPASS, WHEN THE SUTURE THREAD WAS TAKEN OUT OF THE PACKAGE, THE NEEDLE WAS SEPARATED FROM THE THREAD. ANOTHER SUTURE THREAD WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14800499 ↗
• MalfunctionJun 21, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, THE NEEDLE SEPARATED FROM THE THREAD. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14759103 ↗
• MalfunctionDec 9, 2019Break; Break

  ACCORDING TO THE REPORTER, DURING THE PASSAGE OF THE THREAD IN A LAPAROSCOPIC HERNIA PROCEDURE, THE THREAD OF THE SUTURE BROKE. ANOTHER SUTURE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9441077 ↗
• MalfunctionJun 26, 2019Break; Break

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC TBC (TISSUE BONDING CYSTOSTOMY) PROCEDURE, THE DEVICE THREAD BROKE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8736594 ↗
• MalfunctionNov 8, 2017Break; Break

  ACCORDING TO THE REPORTER: OCCURRED DURING AN OPEN BYPASS PROCEDURE IN OMEGA UNDER COELIOSCOPY. THE WIRE LOOP WAS UNDONE WHEN THE SURGEON INSERTED THE NEEDLE INTO THE LOOP TO TIE A KNOT. IN ORDER TO RESOLVE THE ISSUE AND COMPLETE THE CASE, USED ANOTHER SUTURE. THERE WAS NO PATIENT HARM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7010423 ↗