V-Loc 180 VLOCL0004Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10884521130357), received between Sep 20, 2017 and Jan 12, 2024 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Break” (9 reports).

1 other recall cover devices cleared under the same FDA submission (K091087); 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.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 12, 2024Break; Break

  ACCORDING TO THE REPORTER, IN A LAPAROSCOPIC THORACOSCOPY-AIDED PULMONARY RESECTION, DURING THE WOUND CLOSURE (DERMIS SUTURE) USING THE CONTINUOUS DERMAL SUTURING TECHNIQUE, WHEN PASSING THROUGH THE LOOP AT THE START OF SUTURE, THE THREAD BROKE. ANOTHER PACKAGE WAS OPENED AND USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18504566 ↗
• MalfunctionApr 7, 2021Break; Break

  ACCORDING TO THE REPORTER, DURING OPEN HIP REPLACEMENT, UPON CLOSING OF DEEP DERMAL LAYER, THE THREE (3) SUTURES FROM THE SAME BOXES BROKE. THE SURGEON FIRST TRIED TO USE ONE OF THE DEVICES, UPON SNAPPING THE SUTURE, IT WAS DEVIATED TO AN HIGHER USP WHERE SUTURE BREAKING WAS ALSO EXPERIENCED AND BOTH OTHER ITEMS WERE RELATED TO THIS. SURGEON TOOK NEW BOXES AND THE ISSUE WAS RESOLVED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11628637 ↗
• MalfunctionMar 1, 2021Break; Break

  ACCORDING TO THE REPORTER, DURING OPEN HIP REPLACEMENT, UPON CLOSING OF DEEP DERMAL LAYER, THE THREE (3) SUTURES FROM THE SAME BOXES BROKE. THE SURGEON FIRST TRIED TO USE ONE OF THE DEVICES, UPON SNAPPING THE SUTURE, IT WAS DEVIATED TO AN HIGHER USP WHERE SUTURE BREAKING WAS ALSO EXPERIENCED AND BOTH OTHER ITEMS WERE RELATED TO THIS. SURGEON TOOK NEW BOXES AND THE ISSUE WAS RESOLVED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11394646 ↗
• MalfunctionFeb 20, 2020Break; Break

  ACCORDING TO THE REPORTER, WHILE SUTURING THE VAGINAL VAULT DURING A TOTAL LAPAROSCOPIC HYSTERECTOMY, THE FIRST SUTURE OPENED WAS BLUNT AND THE SURGEON WAS STRUGGLING TO GET THE SUTURE THROUGH THE TISSUE. OPENED A SECOND SUTURE, BUT THE THREAD SNAPPED AT THE END OF SUTURING. AFTER THE FIRST SUTURE SNAPPED, THE SURGEON USED A SECOND SUTURE WITH THE SAME BATCH CODE FROM THE SAME BOX IN ORDER TO COMPLETE THE CASE. THIS SUTURE ALSO SNAPPED, BUT THE SUTURING HAD FINISHED AT THAT POINT, AND WAS JUST CHECKING THE HEMOSTASIS, SO A THIRD SUTURE DID NOT OPEN. THERE WAS NO INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9732159 ↗
• MalfunctionJan 21, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRIOR TO PROCEDURE, WHEN OPENING THE PACKAGE AND TRYING TO USE THE SUTURE AT THE TIME OF CLOSING WOUND, THE NEEDLE AND THREAD WERE FOUND TO BE DISENGAGED AND UNABLE TO BE USED. THEREFORE THE DEVICE WAS STOPPED USING AND A NEW SUTURE WAS TAKEN OUT AND USED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8265052 ↗
• MalfunctionApr 24, 2018Mechanical Problem; Mechanical Problem

  ACCORDING TO THE REPORTER, DURING AN OPEN ORTHOPEDIC PROCEDURE, WHEN THE SURGEON WAS PERFORMING A REGULAR SUTURE THE THREE DEVICES HAD AN UNKNOWN ISSUE. THE PATIENT'S OUTCOME WAS ASKED AND WAS UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7454024 ↗
• MalfunctionSep 28, 2017Break; Break

  ACCORDING TO THE REPORTER, THE LOOP BROKE AFTER THE FIRST SUTURING. NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6901616 ↗
• MalfunctionSep 27, 2017Break; Break

  ACCORDING TO THE REPORTER, DURING THE CESAREAN SECTION PROCEDURE, THE PHYSICIAN MADE ONE STITCH ON TISSUE AND HAD THE NEEDLE GET THROUGH THE LOOP, TYING IT UP, THEN THE LOOP BROKE. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. NO HARM WAS CAUSED TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6897768 ↗
• MalfunctionSep 25, 2017Break; Break

  ACCORDING TO THE REPORTER, DURING SUTURING, THE LOOP BROKE WHEN THE DOCTOR MADE 2 STITCHES AND HAVE THE NEEDLE GET THROUGH THE LOOP, TYING IT UP. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THE STATUS OF THE PATIENT IS NO PROBLEM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6891038 ↗
• MalfunctionSep 25, 2017Break; Break

  ACCORDING TO THE REPORTER, DURING A C-SECTION, A DOCTOR MADE ONE STITCH ON TISSUE AND HAD THE NEEDLE GET THROUGH THE LOOP, TYING IT UP, AND THEN THE LOOP BROKE. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THE STATUS OF THE PATIENT IS NO PROBLEM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6890787 ↗
• MalfunctionSep 20, 2017Break; Break

  ACCORDING TO THE REPORTER, DURING USE IN DERMAL SUTURE, THE LOOP BROKE. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. PATIENT STATUS IS WITH NO PROBLEM. NO ADVERSE EVENTS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6880655 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K091087. One submission often covers many models, so check the product and lot details in each record.

• Z-2919-2026 · Jun 24, 2026 · Open, Classified
  V-Loc 180 Absorbable Wound Closure Device BOX BEDSIDE STAPLING IS KING BOX06614V4 BOX BY PASS FINAL BOX07405V1 BOX BYPASS CARDON BOX01056V2 BOX BYPASS DR LAGAE BOX0