V-Loc 90 VLOCM0013Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 10884521131644), received between Aug 24, 2017 and Sep 30, 2026 — classified as 4 injuries, 20 malfunctions.

The most frequently reported specific device problem is “Break” (19 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Jun 24, 2026Class IIOpen, Classified

   Product may contain a perforation or tear in the sterile barrier packaging. This issue may result in biocontamination of the sterile sutures, which may lead to infection, loss of vision if in ophthalmic utilization, or prolonged surgery.

   Z-2918-2026 · Root cause: Equipment maintenance · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50941467 ↗
• MalfunctionSep 29, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50936941 ↗
• MalfunctionDec 19, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC KNEE OPERATION, WHILE SUTURING, THE NEEDLE DETACHED FROM THE SUTURE. AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23854548 ↗
• MalfunctionJul 17, 2025Break; Break

  IT WAS REPORTED THAT DURING A PROCEDURE, THE LOOP BROKE ON BOTH DEVICES WHILE REMOVING FROM THE PACKAGING. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22538404 ↗
• InjuryDec 5, 2022Unraveled Material; Patient-Device Incompatibility; Unraveled Material; Patient-Device Incompatibility

  ACCORDING TO THE REPORTER, POST-OPERATIVELY OF AN OPEN MASSIVE BREAST REDUCTION AND LIPOSUCTION PROCEDURE, THE PATIENT IS MORBIDLY OBESE AND DID GREAT OPERATIVELY AND POST-OPERATIVELY. THE SURGEON USED ABSORBABLE SUTURES VIA A NORMAL RUNNING STITCH TECHNIQUE. THE SURGEON PLACED DRAINS AND LATER REMOVED DRAINS. THE PATIENT HAD CONTINUOUS DRAINAGE ON THE RIGHT SIDE. AFTER FOUR WEEKS OF POST-OPERATION, DURING THE WOUND HEALING, THE SURGEON NOTICED THAT THERE WAS A WOUND BREAKDOWN AND SKIN NECROSIS ON THE MOST LATERAL EXTENSIONS OF THE INCISIONS. ONE OF THE OTHER BREAST INCISIONS HAD A WOUND BREAKDOWN AT THE TRANSVERSE LOCATION AND THERE WAS A GAP WHERE IT HAD DEHISCED. THE SURGEON HAD TO RE-ADMIT THE PATIENT TO DO A DEBRIDEMENT AND CUT APPROXIMATELY 3" OF THE SUTURE OUT, THEN CLOSED WITH ANOTHER ABSORBABLE SUTURE AND A NON-ABSORBABLE SUTURE.

  Patient problems: Necrosis; Wound Dehiscence

  MAUDE report 15920330 ↗
• MalfunctionMar 24, 2021Break; Break

  ACCORDING TO THE REPORTER, DURING AN OPEN PACEMAKER PLACEMENT, THE SUTURE THREAD BROKE AFTER THE NEEDLE WAS PASSED THROUGH THE LOOP TO SET THE STRAND AND BEGIN SUTURING. THE SKIN CLOSURE WAS COMPLETED BY USING ANOTHER SUTURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11563808 ↗
• InjuryMar 1, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, UPON CLOSING THE PACE-MAKER POCKET AFTER INSERTING A PACE MAKER, NEEDLE WAS SEPARATED FROM THE THREAD. WHEN THE TISSUE WAS CLOSED WITH SUTURE, THE NEEDLE CAME LOOSE FROM THE THREAD AND WAS DROPPED INTO THE WOUND. THE NEEDLE AND SUTURE SPLIT UP OR THE NEEDLE RELEASE FROM THE SUTURE AND WENT OFF. THERE WAS TROUBLE IN FINDING THE NEEDLE AS IT FELL DOWN INTO THE TISSUE OF PATIENT, BUT IT WAS REMOVED FROM THE WOUND CAVITY AND SCRAPPED ACCORDING TO THEIR ROUTINE. IT PROLONGED THE OPERATION WITH 30 MINUTES AND AN X-RAY WAS PERFORMED IN LOCATING THE NEEDLE. A NEW SUTURE FROM THE SAME PACKAGE AND CONTINUED THE SUTURING OF THE TISSUE WITHOUT ANY INCIDENT.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 11392006 ↗
• MalfunctionSep 14, 2020Break; Break

  ACCORDING TO THE REPORTER, DURING A BREAST REFORMATION AFTER MASTECTOMY, WHILE CLOSING, THE SUTURE BROKE IN THE MIDDLE OF THE STRAND. THE USER OPENED ANOTHER PACKAGE AND FINISHED THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10530996 ↗
• MalfunctionJun 29, 2020Break; Break

  ACCORDING TO THE REPORTER, ON AN OPEN BREAST REDUCTION, AFTER THREE THROWS DURING THE START OF THE SKIN CLOSURE USING THE RUNNING STITCH TECHNIQUE, THE THREAD BROKE. ADDITIONAL STRAND WAS PULLED TO FINISH THE CLOSURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10209738 ↗
• MalfunctionJan 8, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRIOR TO HYSTERECTOMY, LAPAROSCOPIC PROCEDURE, THE NEEDLE DETACHED FROM THE THREAD. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9567242 ↗
• InjuryNov 19, 2019Break; Break

  ACCORDING TO THE REPORTER, DURING SKIN SUTURING A STRUMECTOMY PROCEDURE, THE NEEDLE BROKE. X-RAY WAS PERFORMED TO CHECK IF THE SHARP TIP OF THE NEEDLE THAT BROKE OFF FELL INTO THE PATIENT'S CAVITY BUT NOTHING WAS FOUND. THE SURGICAL TIME EXTENDED 30 MINUTES OR MORE DUE TO THE PRODUCT PROBLEM. THE PROCEDURE WAS FINISHED WITH THE SAME SUTURE.

  Patient problems: No Code Available; Radiation Exposure, Unintended

  MAUDE report 9344628 ↗
• InjuryNov 12, 2019Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A STRUMECTOMY, ON SKIN SUTURING, THERE WAS A CHANCE THAT THE SHARP TIP OF THE NEEDLE THAT BROKE AND FELL INTO THE PATIENT¿S CAVITY. AN X-RAY WAS PERFORMED FOR THE EXPRESS PURPOSE OF LOCATING THE COMPONENT, OR CONFIRMING THAT ALL PIECES WERE LOCATED. THE X-RAY DID NOT SHOW ANY NEEDLE. THE SURGICAL TIME WAS EXTENDED BY THIRTY MINUTES OR MORE. THE SUTURING WAS FINISHED WITH THE SAME PRODUCT.

  Patient problems: No Code Available; Radiation Exposure, Unintended

  MAUDE report 9313336 ↗
• MalfunctionSep 16, 2019Break; Break

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE THREAD BROKE AFTER A FEW STITCHES WHILE IN USED TO PATIENT BY A SURGICAL NURSE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9073923 ↗
• MalfunctionSep 12, 2019Break; Break

  ACCORDING TO THE REPORTER, DURING THE FINAL CLOSURE OF THE SKIN IN A PACEMAKER BATTERY CHANGE OUT OPEN PROCEDURE, THE THREAD BROKE INTO TWO PIECES. THEY WERE AT THE END OF THE CLOSURE ON THE FINAL PASS, SO THE WOUND WAS CLOSED. THEY PUT TOPICAL SKIN ADHESIVE ON IT AND FINISHED THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9014468 ↗
• MalfunctionFeb 26, 2019Break; Break

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, SHORTLY AFTER THE BEGINNING OF THE SKIN CLOSURE, THE THREADS OF THE SUTURE WERE BROKE AND THE LOOPS WERE OPENED. NEW SUTURE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8369944 ↗
• MalfunctionJan 18, 2019Break; Break

  ACCORDING TO THE REPORTER, DURING L2-4 LAMINECTOMY, WHILE FINAL SKIN CLOSURE APPROXIMATELY 3 INCHES OF STRAND LEFT, THE STRAND BROKE AFTER BEING PULLED THROUGH NORMAL SKIN TISSUE, AS IT NORMALLY WAS PULLED THROUGH WITH REGULAR USE. THE DOCTOR WENT BACK TO HIS PREVIOUS BITE AND KEPT SUTURING LIKE NORMAL, FINISH WITH TWO BACK BITES TOWARDS THE ORIGINAL APEX, A PERPINDICULAR BITE AND A FLUSH CUT. THEY COMPLETED THE CLOSURE WITH WHAT WAS LEFT. IT HAPPENED RIGHT AT THE END. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8260892 ↗
• MalfunctionJan 18, 2019Break; Break

  ACCORDING TO THE REPORTER, DURING AN OPEN NEUROSURGERY PROCEDURE, DURING SUBCUTANEOUS CLOSURE USING A RUNNING SUTURE TECHNIQUE, THE THREAD OF SUTURE BROKE. THEY OPENED A NEW DEVICE TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8260646 ↗
• MalfunctionNov 28, 2018Break; Break

  ACCORDING TO THE REPORTER, DURING AN OPEN PROCEDURE, WHILE ON SUBCUTICULAR CLOSURE, SUTURES BROKE WHEN TRYING TO SECURE THE SUTURE INTO PLACE DURING INITIAL PLACEMENT. IT WAS NOTED THAT THE SUTURE WAS BREAKING AT THE LOOP. THEY OPENED A NEW PACKAGE TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8110533 ↗
• MalfunctionSep 11, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN OPEN LOBECTOMY-MAMMAE, WHEN CLOSING THE FAT, THE THREAD BROKEN AT THE PLACE WHERE IT IS FIXED TO THE NEEDLE AND IT HAPPENED TWICE. 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 7865721 ↗
• MalfunctionFeb 26, 2018Break; Break

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE DEVICE LOOP EASILY BROKE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7297674 ↗
• MalfunctionFeb 2, 2018Break; Break

  ACCORDING TO THE REPORTER, WHILE CLOSING THE SKIN WITH THE SUTURE DURING A OPEN PROCEDURE, THE THREAD BROKE AT THE END OF PROCEDURE. NEW DEVICE WAS OPENED BUT THE SECOND DEVICE FAILED AT THE LOOP BEFORE A THIRD WAS OPENED AND USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7237501 ↗
• MalfunctionDec 15, 2017Break; Break

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE DEVICE HAD BROKEN THREAD. THE LOOP WAS BROKE WHILE CLOSING THE SKIN. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY HAS BEEN NOTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7122213 ↗
• MalfunctionDec 8, 2017Break; Break

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE LOOP AT THE END OF THE DEVICE GOT LOOSE/OPEN WHILE THE DOCTOR WAS SUTURING. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7101948 ↗
• MalfunctionAug 24, 2017Break; Break

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE DEVICE BROKE, THE LOOP AT THE END OF THE DEVICE KEPT BREAKING. NO PATIENT INJURY. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6819545 ↗