V-Loc 90 VLOCM0023Recalls & reported problems

Summary

The FDA's MAUDE database contains 65 adverse event reports that list this exact device (DI 10884521131682), received between Jul 17, 2017 and Mar 20, 2026 — classified as 1 injury, 64 malfunctions.

The most frequently reported specific device problem is “Break” (46 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 25 most recent of 65 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 20, 2026Break

  ACCORDING TO THE REPORTER, DURING AN OPEN SKIN SUTURING, TWO MINUTES INTO THE PROCEDURE, THE THREAD BROKE. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24647977 ↗
• MalfunctionFeb 27, 2026Break

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE LOOP OF THE TAIL END OF THE SUTURE WAS BROKEN. ANOTHER SUTURE FROM THE SAME LOT WAS USED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24466453 ↗
• MalfunctionDec 25, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING WOUND SUTURING, WHILE USING A NEEDLE HOLDER TO PLACE THE FINAL STITCH, THE SUTURE NEEDLE SPRANG OFF. AFTER SEARCHING, THE NEEDLE WAS FOUND ON THE OPERATING ROOM FLOOR. THE SURGEON SUBSEQUENTLY COMPLETED THE PROCEDURE SUCCESSFULLY, AND NO FURTHER HARM WAS CAUSED TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23892358 ↗
• InjuryDec 25, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING BREAST TUMOR REMOVAL AND BREAST RECONSTRUCTION, THE CONNECTION BETWEEN THE SUTURE NEEDLE AND THE SUTURE SUDDENLY DETACHED, AND THE SUTURE NEEDLE WAS INSTANTLY EJECTED DUE TO ITS ELASTICITY. THE DOCTOR INITIALLY JUDGED THIS AS NEEDLE BREAKAGE. AFTER A PRELIMINARY SEARCH, THE NEEDLE WAS NOT FOUND AT THE WOUND SITE, SO THE WOUND WAS FIRST SUTURED AND THE PATIENT WAS SENT TO THE WAITING ROOM. THE SURGICAL STAFF CONTINUED SEARCHING IN THE OPERATING ROOM FOR ABOUT HALF AN HOUR, BUT TO NO AVAIL. RADIOLOGY WAS THEN CONTACTED, AND THE PATIENT WAS BROUGHT INTO THE OPERATING ROOM FOR AN X-RAY OF THE WOUND AREA. THE SUTURE NEEDLE WAS FOUND NOT TO HAVE FALLEN OUTSIDE THE SURGICAL FIELD, BUT HAD INSTEAD DROPPED DIRECTLY INTO THE PATIENT'S SURGICAL WOUND. THE DOCTOR IMMEDIATELY PERFORMED A PROCEDURE TO RETRIEVE THE SUTURE NEEDLE FROM THE PATIENT'S WOUND. THE ISSUE WAS ULTIMATELY RESOLVED SUCCESSFULLY, AND NO OTHER HARM WAS CAUSED TO THE PATIENT. HOWEVER, THIS INCIDENT OBJECTIVELY PROLONGED THE OPERATION TIME AND POSED A SIGNIFICANT INTRAOPERATIVE SAFETY RISK TO THE PATIENT.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 23892349 ↗
• MalfunctionDec 8, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, INTRAOPERATIVELY, THE NEEDLE DETACHED FROM THE SUTURE WHILE SUTURING. AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE.

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

  MAUDE report 23743293 ↗
• MalfunctionOct 17, 2025Break; Break

  IT WAS REPORTED THAT DURING A PROCEDURE, WHILE SUTURING WITH THE DEVICE, THE SUTURE BROKE IN THE MIDDLE. 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 23321007 ↗
• MalfunctionOct 17, 2025Break; Break

  IT WAS REPORTED THAT PREOPERATIVELY, WHILE BEING REMOVED FROM THE PACKAGING, THE LOOP OF THE SUTURE BROKE. AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23320913 ↗
• MalfunctionJul 22, 2025Break; Break

  IT WAS REPORTED THAT THE SUTURE WAS OPENED AND THE THREAD WAS FOUND TO BE BROKEN, WITH A MISSING COIL AT THE END OF THE THREAD. THE DEVICE WAS NEVER IMPLANTED. AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22563887 ↗
• MalfunctionJul 21, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING THE CESAREAN SECTION, WHEN SUTURING THE SKIN, THE NEEDLE AND THREAD WERE DETACHED, RESULTING IN THE INABILITY TO SUTURE THE SKIN. A NEW SUTURE WAS REOPENED AND THE OPERATION WAS CONTINUED AND COMPLETED 5 MINUTES LATER. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22559628 ↗
• MalfunctionMay 13, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A HIP REPLACEMENT SURGERY, THE SUTURES EXPERIENCED BREAKAGE. SPECIFICALLY, THE FASCIA SUTURE AND THE SKIN SUTURE BROKE, WITH BOTH THE NEEDLE AND THREAD OF ONE SUTURE AND THE THREAD OF ANOTHER SUTURE BREAKING FIVE MINUTES INTO THE PROCEDURE. NEW SUTURES WERE USED FOR RE-SUTURING TO RESOLVE THE ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22015290 ↗
• MalfunctionMar 26, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING A CESAREAN SECTION, WHEN THE SURGEON WAS PERFORMING A CONTINUOUS SUTURING TECHNIQUE, THE THREAD BROKE AT THE CONICAL RING AT THE TAIL END OF THE SUTURE. THE SAME ISSUE OCCURRED ON THE SECOND SUTURE. A NEW SUTURE WAS USED TO RE-SUTURE THE TISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21699123 ↗
• MalfunctionMar 26, 2025Break; Break

  ACCORDING TO THE REPORTER DURING A CESAREAN SECTION, WHEN THE SURGEON WAS PERFORMING A CONTINUOUS SUTURING TECHNIQUE, THE THREAD BROKE AT THE CONICAL RING AT THE TAIL END OF THE SUTURE. THE SAME ISSUE OCCURRED ON THE SECOND SUTURE. A NEW SUTURE WAS USED TO RE-SUTURE THE TISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21698022 ↗
• MalfunctionFeb 13, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING A RIGHT KNEE REPLACEMENT, WHEN SUTURING THE SKIN USING THE CONTINUOUS SUTURING TECHNIQUE, FOUR SUTURES BROKE. IT WAS NOTED THAT IT LASTED FIVE MINUTES. ANOTHER SUTURES WERE USED FOR RESTITCHING TO RESOLVED THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21374833 ↗
• MalfunctionFeb 13, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING A RIGHT KNEE REPLACEMENT, WHEN SUTURING THE SKIN USING THE CONTINUOUS SUTURING TECHNIQUE, FOUR SUTURES BROKE. IT WAS NOTED THAT IT LASTED FIVE MINUTES. ANOTHER SUTURE WERE USED FOR RESTITCHING TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21374828 ↗
• MalfunctionFeb 13, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING A RIGHT KNEE REPLACEMENT, WHEN SUTURING THE SKIN USING THE CONTINUOUS SUTURING TECHNIQUE, FOUR SUTURES BROKE. IT WAS NOTED THAT IT LASTED FIVE MINUTES. ANOTHER SUTURES WERE USED FOR RESTITCHING TO RESOLVED THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21374824 ↗
• MalfunctionFeb 10, 2025Unraveled Material; Unraveled Material

  IT WAS REPORTED THAT DURING A LOBECTOMY PROCEDURE INVOLVING THE SUTURE, THE SUTURE LINE DID NOT HOLD. 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 21350644 ↗
• MalfunctionJan 27, 2025Break; Break

  IT WAS REPORTED THAT DURING A JOINT REPLACEMENT PROCEDURE, THE FOUR THREADS BROKE FIVE MINUTES INTO THE PROCEDURE, AND THE DEVICE WAS BEING APPLIED TO CLOSE THE WOUND. THE ISSUE WAS RESOLVED BY SWITCHING TO ANOTHER SUTURE TO CONTINUE THE PROCEDURE. THERE WAS NO NEED FOR ADDITIONAL OPERATIONS, AND THE PATIENT OUTCOME WAS REPORTED AS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21241112 ↗
• MalfunctionJan 27, 2025Break; Break

  IT WAS REPORTED THAT DURING A JOINT REPLACEMENT PROCEDURE, THE FOUR THREADS BROKE FIVE MINUTES INTO THE PROCEDURE, AND THE DEVICE WAS BEING APPLIED TO CLOSE THE WOUND. THE ISSUE WAS RESOLVED BY SWITCHING TO ANOTHER SUTURE TO CONTINUE THE PROCEDURE. THERE WAS NO NEED FOR ADDITIONAL OPERATIONS, AND THE PATIENT OUTCOME WAS REPORTED AS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21240921 ↗
• MalfunctionJan 24, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING A PACEMAKER IMPLANTATION, WHEN SUTURING THE SKIN, THE SUTURE THREAD BROKE. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21231409 ↗
• MalfunctionJan 24, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING A RIGHT KNEE REPLACEMENT, WHEN SUTURING THE SKIN USING THE CONTINUOUS SUTURING TECHNIQUE, FOUR SUTURES BROKE. IT WAS NOTED THAT IT LASTED FIVE MINUTES. ANOTHER SUTURES WERE USED FOR RESTITCHING TO RESOLVED THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21230758 ↗
• MalfunctionJan 23, 2025Break; Break

  ACCORDING TO THE REPORTER, IN AN OPEN JOINT REPLACEMENT PROCEDURE, WHEN CLOSING THE WOUND USING THE CONTINUOUS SUTURING TECHNIQUE, ONE SUTURE HAD ITS NEEDLE DETACHED FROM THE THREAD TWO MINUTES INTO THE PROCEDURE. TWO OTHER SUTURES HAD BROKEN THREADS TWO MINUTES INTO THE PROCEDURE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21215689 ↗
• MalfunctionJan 13, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, THE SURGEON FOUND THAT THE WOUND OPENED UP DUE TO A SUTURE BROKEN WHICH RESULTED TO PROLONGED TIME OF SURGERY. A SUTURING WAS DONE TO SOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

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

  MAUDE report 21137818 ↗
• MalfunctionNov 26, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING A LOBECTOMY, WHEN SUTURING THE TISSUE, THE SUTURE LINE BROKE. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20779675 ↗
• MalfunctionNov 6, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, WHILE SUTURING, THE SUTURE BROKE IN THE MIDDLE. TO RESOLVE THE ISSUE, A NEW DEVICE WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20625434 ↗
• MalfunctionSep 27, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A GRANULATION TISSUE EXCISION ON THE PATIENT'S LEFT BREAST, THE SUTURE PACKAGE WAS OPENED, AND THE NEEDLE OF THE SUTURE WAS CLAMPED WITH A NEEDLE HOLDER. WHEN PULLING THE SUTURE FOR THE FIRST STITCH, THE NEEDLE AND SUTURE WERE FOUND TO BE DETACHED, SO REPLACED WITH A NEW SUTURE OF ANOTHER BRAND FOR USE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20328154 ↗

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