V-Loc 90 VLOCM1704Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10884521132863), received between Sep 5, 2017 and Jan 21, 2026 — classified as 1 injury, 15 malfunctions.

The most frequently reported specific device problem is “Break” (11 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 21, 2026Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC RADICAL PROSTATECTOMY, DURING BLADDER AND URETHRA ANASTOMOSIS, THE FIVE SUTURES BROKE UPON OPENING THE PACKAGING. TO RESOLVE THE ISSUE, ANOTHER SUTURE FROM A DIFFERENT MANUFACTURER WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24127830 ↗
• MalfunctionJan 21, 2026Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC RADICAL PROSTATECTOMY, DURING BLADDER AND URETHRA ANASTOMOSIS, THE FIVE SUTURES BROKE UPON OPENING THE PACKAGING. TO RESOLVE THE ISSUE, ANOTHER SUTURE FROM A DIFFERENT MANUFACTURER WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24127828 ↗
• MalfunctionJan 21, 2026Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC RADICAL PROSTATECTOMY, DURING BLADDER AND URETHRA ANASTOMOSIS, THE FIVE SUTURES BROKE UPON OPENING THE PACKAGING. TO RESOLVE THE ISSUE, ANOTHER SUTURE FROM A DIFFERENT MANUFACTURER WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24127825 ↗
• MalfunctionJan 21, 2026Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC RADICAL PROSTATECTOMY, DURING BLADDER AND URETHRA ANASTOMOSIS, THE FIVE SUTURES BROKE UPON OPENING THE PACKAGING. TO RESOLVE THE ISSUE, ANOTHER SUTURE FROM A DIFFERENT MANUFACTURER WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24127819 ↗
• MalfunctionJan 21, 2026Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC RADICAL PROSTATECTOMY, DURING BLADDER AND URETHRA ANASTOMOSIS, THE FIVE SUTURES BROKE UPON OPENING THE PACKAGING. TO RESOLVE THE ISSUE, ANOTHER SUTURE FROM A DIFFERENT MANUFACTURER WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24127808 ↗
• MalfunctionJul 29, 2025Break; Break

  IT WAS REPORTED THAT DURING A RIGHT HEMICOLECTOMY, THREE SUTURES BROKE IN SUCCESSION. THE FIRST SUTURE BROKE NEAR THE END OF ITS USE AFTER BEING HELD AND MANIPULATED BY LARGE NEEDLE DRIVERS. THE SECOND SUTURE BROKE ALMOST INSTANTLY AFTER BEING HELD BY THE NEEDLE DRIVERS. THE THIRD SUTURE BROKE IN A SIMILAR MANNER TO THE FIRST, AFTER APPROXIMATELY FIVE MINUTES OF USE. ALL THREE SUTURES BROKE ABOUT ONE-THIRD OF THE WAY DOWN THE SUTURE, NOT AT THE END NEAR THE NEEDLE. IT WAS REPLACED WITH A WORKING SUTURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22644168 ↗
• MalfunctionJul 29, 2025Break; Break

  IT WAS REPORTED THAT DURING A RIGHT HEMICOLECTOMY, THREE SUTURES BROKE IN SUCCESSION. THE FIRST SUTURE BROKE NEAR THE END OF ITS USE AFTER BEING HELD AND MANIPULATED BY LARGE NEEDLE DRIVERS. THE SECOND SUTURE BROKE ALMOST INSTANTLY AFTER BEING HELD BY THE NEEDLE DRIVERS. THE THIRD SUTURE BROKE IN A SIMILAR MANNER TO THE FIRST, AFTER APPROXIMATELY FIVE MINUTES OF USE. ALL THREE SUTURES BROKE ABOUT ONE-THIRD OF THE WAY DOWN THE SUTURE, NOT AT THE END NEAR THE NEEDLE. IT WAS REPLACED WITH A WORKING SUTURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22644006 ↗
• MalfunctionMay 20, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A ROBOTIC RADICAL PROSTATECTOMY PROCEDURE, THE NEEDLE DETACHED FROM THE THREAD IN THE MIDDLE OF THE PROCEDURE. AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE.

  Patient problems: Insufficient Information

  MAUDE report 22056315 ↗
• MalfunctionJan 10, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, UPON CLOSING, THE THREAD BROKE. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16129749 ↗
• MalfunctionJun 28, 2022Break; Break

  ACCORDING TO THE REPORTER, INTRAOPERATIVELY, WHILE STITCHING ON WOUND CLOSURE, THE THREAD BROKE FINELY. A NEW PRODUCT OF THE SAME STANDARD WAS OPENED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: Insufficient Information

  MAUDE report 14842128 ↗
• MalfunctionJun 14, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC RADICAL PROSTATECTOMY, THE PRODUCTS WERE USED DURING ANASTOMOTIC OF THE BLADDER AND URETHRA UNDER THE FLUOROSCOPY. WHEN AN ATTEMPT WAS MADE TO SUTURE THE TISSUE, THE NEEDLE WAS PULLED WITH A HUB, AND THE THREAD BROKE NEAR THE THREAD ATTACHING PART. THIS OCCURRED IN TWO CONSECUTIVE PACKETS. A NEW PRODUCT WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

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

  MAUDE report 14685532 ↗
• MalfunctionSep 29, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THREE DEVICES WITH THE SAME LOT NUMBER HAD NEEDLES SEPARATED FROM THE THREAD. ANOTHER DEVICE WITH ANOTHER LOT NUMBER WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12548073 ↗
• InjuryJun 4, 2021Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, ON A LAPAROSCOPIC RADICAL PROSTATECTOMY, AFTER THE PROSTATE REMOVAL, WHILE THE SURGEON WAS TRYING TO SUTURE THE TISSUE USING THE CONTINUOUS STITCH TECHNIQUE WITH A LAPAROSCOPIC NEEDLE HOLDER, THE NEEDLE BROKE AND FELL INTO THE PATIENT¿S CAVITY. THE NEEDLE WAS FOUND AFTER CONVERTING THE LAPAROSCOPIC PROCEDURE INTO AN OPEN SURGERY. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THE SURGERY WAS EXTENDED FOR MORE THAN AN HOUR DUE TO THE ISSUE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 11941088 ↗
• MalfunctionMar 29, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC LIVER SURGERY, AT THE END OF THE PROCEDURE, THE NEEDLE DETACHED FROM THE THREAD AS A WHOLE. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11580556 ↗
• MalfunctionOct 28, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE NEEDLE AND THE THREAD SEPARATED AFTER THE FIRST PASSAGE INTO THE TISSUE. ANOTHER SUTURE WAS TAKEN TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9248257 ↗
• MalfunctionSep 5, 2017Detachment Of Device Component; Detachment of Device or Device Component; Detachment Of Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER: OCCURRED DURING A LAPAROSCOPIC PROCEDURE. THE THREAD OF THE DEVICE BROKE BECAUSE THE SUTURE CAME OFF THE NEEDLE. IT WAS FOUND AFTER 30 MINUTES IN THE RIM OF THE TROCAR. NO KNOWN IMPACT OR CONSEQUENCE TO PATIENT.

  Patient problems: No Code Available; No Known Impact Or Consequence To Patient

  MAUDE report 6841987 ↗

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