V-Loc 90 VLOCM2245Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884521133037), received between May 13, 2019 and Jun 12, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K100257); 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 12, 2019Break; Break

  ACCORDING TO THE REPORTER, DURING TOTAL LAPAROSCOPIC ROBOTIC ASSISTED HYSTERECTOMY, THE 3 DEVICES WERE KEPT BRAKING. A FOURTH DEVICE OF THE DIFFERENT LOT WAS SUCCESSFULLY USED TO CONTINUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8692513 ↗
• MalfunctionMay 13, 2019Break

  DURING A CASE IT WAS NOTED THAT TEMPORARY V-LOCS KEPT BRAKING. STAFF WENT THROUGH 3 OF THEM THEN DECIDED TO USE A DIFFERENT LOT NUMBER. THE PHYSICIAN STATED HE DID NOT PUT ANY STRAIN THAT IT HAD ANY REASON TO BRAKE. A FOURTH DEVICE OF A DIFFERENT LOT WAS SUCCESSFULLY USED WITH NO HARM TO THE PATIENT. UNFORTUNATELY THE DEFECTIVE VLOCS WERE NOT SAVED, NOR WAS A LOT NUMBER RECORDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8603332 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K100257. One submission often covers many models, so check the product and lot details in each record.

• Z-2918-2026 · Jun 24, 2026 · Open, Classified
  V-Loc 90 Absorbable Wound Closure Device VLOC 90 0 VL 22 GS-21 VLOCM0336 VLOC 90 0 VL 22 GS-25 VLOCM0436 VLOCM0436 VLOCM0003 V-LOC* 90 4-0 CLR 15CM P12X12 VLOCM0003 VL