V-Loc 180 VLOCL0844Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10884521131354), received between Mar 19, 2018 and Oct 21, 2025 — classified as 1 injury, 10 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (6 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.

• MalfunctionOct 21, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING TOTAL KNEE ARTHROPLASTY, THE LOOP BROKE. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23349156 ↗
• MalfunctionOct 17, 2025Break; Break

  IT WAS REPORTED THAT DURING A PROCEDURE, THE SUTURE BROKE IN THE MIDDLE WHILE SUTURING. AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23328919 ↗
• MalfunctionJul 31, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  ACCORDING TO THE REPORTER, THE SUTURE WAS USED DURING A DERMAL SUTURING PROCEDURE, AFTER WHICH THE PATIENT DEVELOPED A REDDISH-BROWN RASH AROUND THE WOUND SITE THAT WAS DISTINCT FROM A HEMATOMA, AS CONFIRMED BY THE PHYSICIAN. ALTHOUGH THE REACTION APPEARED IMMEDIATELY AFTER SURGERY UPON RETURNING TO THE HOSPITAL ROOM, THE RASH RESOLVED WITHIN A FEW DAYS WITHOUT LASTING SYMPTOMS. INITIALLY, ANTICOAGULATION THERAPY WAS WITHHELD DUE TO CONCERNS ABOUT A POSSIBLE HEMATOMA, HOWEVER, AFTER 24 HOURS OF OBSERVATION, IT WAS DETERMINED NOT TO BE HEMATOMA-RELATED, AND ANTICOAGULATION THERAPY WAS RESUMED.

  Patient problems: Rash

  MAUDE report 22676363 ↗
• MalfunctionJun 24, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING A TOTAL KNEE ARTHROPLASTY (TKA) PROCEDURE, THE SUTURE WAS FOUND TO HAVE LOOP DAMAGE WHEN REMOVED FROM ITS PACKAGING, PRIOR TO IMPLANTATION. A NEW SUTURE WAS USED WITHOUT ANY FURTHER ISSUES. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22324731 ↗
• MalfunctionMar 3, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER DURING A ROBOTIC PROSTATECTOMY, THE THREAD DETACHED FROM THE NEEDLE. WHICH FELL INTO THE SURGICAL FIELD PROXIMAL TO THE PATIENT AND WAS RETRIEVED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21501444 ↗
• MalfunctionJan 22, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, PRIOR TO PATIENT USE AND WHEN THE PACKET WAS OPENED, WHILE PULLING OUT FROM THE RETAINER THE NEEDLE AND THREAD WERE DETACHED. TO RESOLVE THE ISSUE, A NEW SUTURE WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21213749 ↗
• MalfunctionApr 24, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC TOTAL PROSTATECTOMY, WHEN CREATING THE VESICOURETHRAL ANASTOMOSIS, THE SUTURE BROKE. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19177594 ↗
• InjurySep 7, 2022Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE NEEDLE BROKE OFF THE SUTURE IN THE MUSCLE OF THE URETHRA. THE NEEDLE ALSO NOTED TO BE BROKEN AND PART OF NEEDLE FELL INTO THE CAVITY. THE SURGEON DETERMINED IT WOULD DO MORE HARM TO RETRIEVE THE NEEDLE SO IT WAS LEFT  IN THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 15375054 ↗
• MalfunctionJun 24, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRIOR TO LAPAROSCOPIC SLEEVE GASTRECTOMY, UPON OPENING PACKAGE, THE NEEDLE WAS DETACHED FROM THE STRAND INSIDE THE PACKAGING. A NEW STRAND WAS PULLED AND OPENED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10188495 ↗
• MalfunctionSep 5, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC INGUINAL HERNIA REPAIR, THE OCCLUSION OF THE SMALL INTESTINE ON THE TIP OF THE DEVICE REMAINED IN PLACE AFTER INTERVENTION. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7847841 ↗
• MalfunctionMar 19, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A ROBOTIC LAPAROSCOPIC PROSTATECTOMY PROCEDURE, AT THE TIME OF THE URETHROVESICAL ANASTOMOSIS, THE DEVICE¿S NEEDLE DETACHED, WHEREIN THE NEEDLE LOOSENED THE WIRE DURING THE SURJECTION PERFORMED IN THE ROBOT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7351404 ↗

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