V-Loc 180 VLOCL0034Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10884521130463), received between Nov 22, 2017 and Nov 1, 2019 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 1, 2019Break; Break

  ACCORDING TO THE REPORTER, WHEN SUTURING DURING A PROCEDURE, THE THREAD PRESENTED RUPTURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9266153 ↗
• InjuryMay 8, 2019Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING SUBCUTANEOUS SUTURE, THE NEEDLE BROKE FROM THE ROOT PART OF NEEDLE SWAGE WHEN SUTURING ON THE TISSUE. AS THE BROKEN NEEDLE HAD FELL INTO PATIENT'S BODY AND COULD NOT BE OBSERVED BY EYES, THE BROKEN NEEDLE WAS FOUND AND TAKEN OUT UNDER FLUOROSCOPIC GUIDANCE. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE.

  Patient problems: Radiation Exposure, Unintended

  MAUDE report 8593636 ↗
• MalfunctionNov 28, 2018Break; Break

  ACCORDING TO THE REPORTER, THE THREAD BROKE DURING THE SUTURING. A NEW PACKET WAS USED AND THE CASE WAS COMPLETED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8111417 ↗
• MalfunctionOct 18, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A DERMOLIPECTOMY PROCEDURE, ON THE SUBCUTANEOUS SUTURE, THERE WAS A DISENGAGEMENT BETWEEN THE SUTURE AND THE NEEDLE. THE PRODUCT WAS REPLACED BY ANOTHER FROM THE SAME LOT NUMBER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7978919 ↗
• MalfunctionNov 22, 2017Break; Break

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, THE DEVICE¿S NEEDLE BROKE. THE SUTURE WAS NOT USED BECAUSE OF THE PROBLEM OF DECORTICATION WHEN LEAVING THE PACKAGING. NEW DEVICE WAS USED TO COMPLETE THE CASE. PATIENT OUTCOME WAS UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7053441 ↗

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