V-Loc 180 VLOCL1544Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10884521131460), received between Sep 28, 2017 and Dec 16, 2025 — classified as 4 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Break” (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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryDec 16, 2025Detachment of Device or Device Component; Insufficient Device Problem Information; Detachment of Device or Device Component; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE NEEDLE DETACHED AND FALL INTO PATIENT'S CAVITY. THE NEEDLE WAS EVENTUALLY RECOVERED DURING CLEANING BY AN X-RAY MACHINE. IT WAS NOTED THAT THE PROCEDURE TIME WAS DOUBLED AND WAS POSTPONED.

  Patient problems: Insufficient Information; Unintended Radiation Exposure

  MAUDE report 23823758 ↗
• InjuryNov 28, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC GASTRIC BAND REMOVAL, THE SUTURE THREAD WAS MOUNTED ON A NEEDLE HOLDER, NEXT TO THE NEEDLE SO THAT IT COULD PASS THROUGH THE TROCAR. WHEN THE NEEDLE HOLDER CAME INTO VIEW, THE NEEDLE WAS GONE, BUT THE THREAD WAS STILL MOUNTED ON THE NEEDLE HOLDER. THE NEEDLE WAS EVENTUALLY RECOVERED DURING CLEANING BY AN X-RAY MACHINE. IT WAS NOTED THAT THE PROCEDURE TIME WAS DOUBLED.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 23669994 ↗
• MalfunctionOct 9, 2020Break; Break

  ACCORDING TO THE REPORTER, WHEN STITCHING ON AN OPEN BARBED REPOSITION PHARYNGOPLASTY, TWO NEEDLES BROKE. ANOTHER DEVICE WAS USED. THE SURGERY LASTED 10 MINUTES LONGER. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10655676 ↗
• MalfunctionOct 9, 2020Break; Break

  ACCORDING TO THE REPORTER, WHEN STITCHING ON AN OPEN BARBED REPOSITION PHARYNGOPLASTY, TWO NEEDLES BROKE. ANOTHER DEVICE WAS USED. THE SURGERY LASTED 10 MINUTES LONGER. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10655594 ↗
• InjuryAug 19, 2020Break; Unraveled Material; Break; Unraveled Material

  ACCORDING TO THE REPORTER, 2 WEEKS FOLLOWING TOTAL LAPAROSCOPIC HYSTERECTOMY, THE THREAD BROKE. IT WAS ALSO REPORTED THAT THERE WAS AN ESTIMATED BLOOD LOSS OF 900 CC. A SECOND PROCEDURE WAS NEEDED TO REPAIR THE DAMAGE.

  Patient problems: Blood Loss; No Code Available; Tissue Damage

  MAUDE report 10429266 ↗
• MalfunctionJan 21, 2019Break; Break

  ACCORDING TO THE REPORTER, DURING AT THE END OF LAPAROSCOPIC PROCEDURE BILATERAL INGUINAL HERNIA TREATMENT, AT THE TIME OF THE SUTURE OF THE PERITONEUM, ON THE RIGHT SIDE, THE THERMO-WELDED STOP LOOP AT THE END OF THE WIRE BROKE AND THE SUTURE COMPLETELY BROKE. THE WIRE HAD BEEN REMOVED AND THE CLOSURE OF THE PERITONEUM WAS TREATED BY HEMLOCK CLIPS AND ANOTHER V-LOC WIRE FROM ANOTHER BATCH. IT RESULTS IN A FRAGILIZATION OF THE PERITONEUM WITH OCCLUSION RISKS BY THE POTENTIAL CONTACT BETWEEN THE PROTHESIS AND THE SMALL INTESTINE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8265445 ↗
• MalfunctionMay 10, 2018Break; Break

  ACCORDING TO THE REPORTER, WHILE THE SURGEON WAS EMPLOYING A CONTINUOUS SUTURING TECHNIQUE IN THE BEGINNING OF THE CLOSURE DURING A LAPAROSCOPIC GASTRIC BYPASS, THE SUTURE THREAD BROKE AND COULD NOT BE USED. THEY TOOK A NEW SUTURE TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7503075 ↗
• MalfunctionMay 10, 2018Break; Break

  ACCORDING TO THE REPORTER, AT THE BEGINNING OF CLOSURE OF A LAPAROSCOPIC GASTRIC BYPASS, THE THREAD BROKE WHILE THEY USED A CONTINUOUS SUTURING TECHNIQUE. THEY USED A NEW SUTURE TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7502941 ↗
• InjurySep 28, 2017Unraveled Material; Unraveled Material

  ACCORDING TO THE REPORTER: OCCURRED POST-OPERATIVELY AFTER A LAPAROSCOPIC GASTRIC BYPASS. THE SURGEON EMPLOYED A RUNNING STITCH USING BARBED SUTURE. THE SUTURE WAS REMOVED APPROXIMATELY 10-15 MINUTES PRIOR TO USE. THE PATIENT WAS RE-ADMITTED TO THE ER DUE TO LEAKAGE. THERE WAS A HOLE IN THE JEJUNUM AT THE CLOSING OF THE ENTEROTOMY. THE PATIENT DEVELOPED PERITONITIS AND SEPSIS. TO CORRECT THE ISSUE, AN ADDITIONAL OPERATION WAS PERFORMED TO CLOSE THE HOLE IN THE JEJUNUM AND CLEAN THE BOWELS. THIS EXTENDED PATIENT HOSPITALIZATION. THE PATIENT HAD TO BE RESUSCITATED IN THE ICU. CURRENT PATIENT STATUS IS STABLE.

  Patient problems: Injury; No Code Available; Peritonitis; Sepsis

  MAUDE report 6901799 ↗

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