V-Loc 180 VLOCL0033Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10884521130449), received between Aug 21, 2017 and Mar 31, 2023 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Break” (7 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 31, 2023Break; Break

  ACCORDING TO THE REPORTER, PREOPERATIVELY, WHEN THE PACKAGE WAS OPENED, THE THREAD WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16656864 ↗
• MalfunctionDec 9, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC HYSTERECTOMY, THE THREAD CAME OFF THE NEEDLE IMMEDIATELY. THE SURGEON USED NEW PRODUCT TO RESOLVE THE ISSUE. THE EVENT OCCURRED DURING THE PROCEDURE, BUT THE PRODUCT WAS NOT USED FOR PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9438629 ↗
• MalfunctionApr 10, 2018Break; Break

  ACCORDING TO THE REPORTER, DURING A SKIN CLOSURE, WHILE CLOSING THE CHEST WOUND, THE SURGEON HAD THE NEEDLE GO THROUGH THE LOOP AND TIED IT UP, BUT THE LOOP BROKE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7412251 ↗
• MalfunctionNov 17, 2017Break; Break

  ACCORDING TO THE REPORTER: TWO SUTURE LOOPS BROKE IN A ROW. THE EVENT OCCURRED DURING THE PROCEDURE BUT THE PRODUCTS WERE NOT USED ON THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT HARM. THE STATUS OF THE PATIENT IS NO PROBLEMS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7040878 ↗
• MalfunctionOct 4, 2017Break; Break

  ACCORDING TO THE REPORTER, DURING SUTURING IN A MASTECTOMY PROCEDURE, THE LOOP BROKE WHEN THE DOCTOR TIED UP THE THREAD. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO INJURY CAUSED TO THE PATIENT AND NO MEDICAL INTERVENTION WAS REQUIRED AS A RESULT OF THE DEVICE ISSUE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6914069 ↗
• MalfunctionSep 6, 2017Break; Break

  ACCORDING TO THE REPORTER, DURING THE CORONARY BYPASS PROCEDURE, WHEN A DOCTOR STARTED SUTURING, 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 6846063 ↗
• MalfunctionSep 5, 2017Break; Break

  ACCORDING TO THE REPORTER, DURING THE CORONARY BYPASS PROCEDURE, WHEN A DOCTOR STARTED SUTURING, 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 6841852 ↗
• MalfunctionAug 21, 2017Break; Break

  ACCORDING TO THE REPORTER: DURING TOTAL GASTRECTOMY/END TO END ANASTOMOSIS WHILE DERMAL SUTURING, ON THE THIRD STITCH, THE ROPE BROKE AND THE THREAD GOT THROUGH. NO PATIENT HARM REPORTED. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6808359 ↗

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