V-Loc 180 VLOCL0603Recalls & reported problems

Summary

The FDA's MAUDE database contains 53 adverse event reports that list this exact device (DI 10884521131125), received between Jun 11, 2018 and Jun 14, 2026 — classified as 2 injuries, 51 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (29 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 25 most recent of 53 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 14, 2026Break

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE SUTURE BROKE DURING USE PROLONGING THE OPERATION TIME BUT NOT MORE THAN 30 MINUTES.

  Patient problems: Insufficient Information

  MAUDE report 25497866 ↗
• MalfunctionMar 12, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT PRE-OPERATIVELY FOR A RESPIRATORY SURGERY CASE, WHEN PULLING OUT FROM THE RETAINER AND PREPARING FOR SUTURING, THE NEEDLE WAS DETACHED. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24584216 ↗
• MalfunctionFeb 18, 2026Break

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE SUTURE BROKE. ANOTHER SUTURE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24375086 ↗
• MalfunctionDec 23, 2025Break; Break

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC PANCREATICODUODENECTOMY, SPECIFICALLY DURING THE PANCREATOJEJUNOSTOMY STEP, THREE SUTURES EXPERIENCED THREAD BREAKAGE. AN ADDITIONAL NEW SUTURE OF THE SAME PRODUCT ID AND LOT WAS USED WITHOUT ISSUE TO COMPLETE THE CASE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23882783 ↗
• MalfunctionDec 23, 2025Break; Break

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC PANCREATICODUODENECTOMY, SPECIFICALLY DURING THE PANCREATOJEJUNOSTOMY STEP, THREE SUTURES EXPERIENCED THREAD BREAKAGE. AN ADDITIONAL NEW SUTURE OF THE SAME PRODUCT ID AND LOT WAS USED WITHOUT ISSUE TO COMPLETE THE CASE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23882770 ↗
• MalfunctionDec 23, 2025Break; Break

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC PANCREATICODUODENECTOMY, SPECIFICALLY DURING THE PANCREATOJEJUNOSTOMY STEP, THREE SUTURES EXPERIENCED THREAD BREAKAGE. AN ADDITIONAL NEW SUTURE OF THE SAME PRODUCT ID AND LOT WAS USED WITHOUT ISSUE TO COMPLETE THE CASE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23882761 ↗
• MalfunctionNov 5, 2025Break; Break

  ACCORDING TO THE REPORTER, BEFORE AN OPEN PROCEDURE, WHEN THE DEVICE WAS OPENED, THERE WAS NO COIL. THE DEVICE WAS NOT USED. TO RESOLVE THE ISSUE, ANOTHER DEVICE WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23476715 ↗
• MalfunctionNov 3, 2025Break; Break

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC GYNECOLOGICAL OVARY PROCEDURE, WHILE BEING APPLIED TO THE OVARIES, THE SUTURE THREAD BROKE AT THE SECOND STITCH. THE ISSUE WAS RESOLVED BY REPLACING THE DEVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23453063 ↗
• MalfunctionJul 22, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING THE HEPATOBILIARY SURGERY, WHEN THE LEAD SURGEON USED A NEEDLE HOLDER TO GRASP THE SUTURE AND PREPARED TO INSERT IT INTO THE ABDOMINAL CAVITY FOR SUTURING, IT WAS FOUND THAT THERE WAS NO NEEDLE AT THE FRONT END OF THE SUTURE. THE CONNECTION BETWEEN THE NEEDLE AND SUTURE BROKE. THE CIRCULATING NURSE QUICKLY SEARCHED AND FOUND THE NEEDLE AROUND THE INCISION. AFTER CONFIRMING THAT THE NEEDLE WAS INTACT WITH NO DAMAGE, THE PRODUCT WAS REPLACED, AND THE SURGERY CONTINUED WITHOUT CAUSING ANY ADVERSE EFFECTS TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22571830 ↗
• MalfunctionJul 16, 2025Break; Break

  ACCORDING TO THE REPORTER DURING A PEDIATRIC SURGERY, WHEN IT WAS PLACED INTO THE ABDOMINAL CAVITY. IT WAS FOUND THAT THE NEEDLE BODY OF THE PRODUCT WAS BROKEN AND COULD NOT BE USED. THE BROKEN NEEDLE WAS REMOVED, AND ITS INTEGRITY WAS CONFIRMED. TO RESOLVE THE ISSUE, THE SUTURE WAS REPLACED AND THE SURGERY CONTINUED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22517441 ↗
• MalfunctionJul 15, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING THE PREOPERATIVE PREPARATION, THE LOOP WAS FOUND TO BE DAMAGED AFTER THE PRODUCT WAS OPENED. A NEW SUTURE WAS USED WITHOUT ANY PROBLEMS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22516186 ↗
• MalfunctionJun 18, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING THE LAPAROSCOPIC DISTAL GASTRECTOMY, WHEN ON JEJUNOJEJUNOSTOMY, THE THREAD BROKE FOR THE TWO SUTURES WHILE USING CONTINUOUS SUTURING. TO RESOLVE THE ISSUE, THE SURGEON SWITCHED TO BARBED SUTURES FROM ANOTHER MANUFACTURER FOR SUTURING. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22288583 ↗
• MalfunctionJan 4, 2025Break; Break

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY OF A LAPAROSCOPIC PROCEDURE, THE NEEDLE BROKE INTO THE BODY CAVITY DURING SUTURING. THE BROKEN END OF THE NEEDLE WAS IMMEDIATELY REMOVED TO CONFIRM ITS INTEGRITY AND WAS REPLACED WITH A NEW SUTURE. THE OPERATION WAS COMPLETED BY RE-SUTURING. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21075077 ↗
• InjuryDec 27, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A GASTRECTOMY, THE NEEDLE DETACHED FROM THE THREAD FOR BOTH DEVICES. THE NEEDLE THEN FELL INTO THE PATIENT'S CAVITY. THE NEEDLE WAS REMOVED, HOWEVER, AN X-RAY HAD TO BE PERFORMED VIA C-ARM. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 21029379 ↗
• InjuryDec 27, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A GASTRECTOMY, THE NEEDLE DETACHED FROM THE THREAD FOR BOTH DEVICES. THE NEEDLE THEN FELL INTO THE PATIENT'S CAVITY. THE NEEDLE WAS REMOVED, HOWEVER, AN X-RAY HAD TO BE PERFORMED VIA C-ARM. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 21029270 ↗
• MalfunctionOct 3, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING A GASTROINTESTINAL SURGERY, THE SUTURE BROKE AND COULD NOT BE USED ANY LONGER. THE SUTURE WAS REPLACED OF THE SAME TYPE TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20360091 ↗
• MalfunctionAug 12, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING A GASTRIC TUMOR RESECTION PROCEDURE, THE THREAD WAS SHORTER, THE SUTURE BODY BREAKAGE, DOES NOT APPEAR AS EXPECTED. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

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

  MAUDE report 19961747 ↗
• MalfunctionAug 5, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING A GASTRIC TUMOR RESECTION PROCEDURE, WHEN THE SURGEON WAS USING ABSORBABLE SUTURE ON A PATIENT, THE SUTURE 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 19907257 ↗
• MalfunctionMay 13, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PARTIAL GASTRECTOMY CONTINUOUS SUTURE, WHEN THE PACKAGE WAS OPENED, IT WAS FOUND THAT THE THREAD WAS BROKEN. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19299407 ↗
• MalfunctionApr 15, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A TRANSTHORACIC ESOPHAGEAL CARCINOMA RESECTION, WHILE SUTURING, THE THREAD BROKE OFF THE NEEDLE. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19106845 ↗
• MalfunctionJan 16, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC INGUINAL HERNIA REPAIR SURGERY, WHEN CLOSING THE PERITONEUM, THE NEEDLE CAME OFF THE SUTURE. THE LOOP OF THE SUTURE ALSO CAME OFF. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18522430 ↗
• MalfunctionJan 16, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN OPEN THYROIDECTOMY, PRIOR TO USE, THE NEEDLE AND THREAD OF THE DEVICE BROKE. TO RESOLVE THE ISSUE, ANOTHER PACK OF SUTURES WAS OPENED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18520138 ↗
• MalfunctionNov 21, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, AFTER OPENING THE PACKAGE, THERE WAS A NEEDLE AND THREAD SEPARATION. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18187934 ↗
• MalfunctionOct 10, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A RIGHT THYROID LOBE RESECTION OR LOBECTOMY PROCEDURE, WHEN THE DEVICE WAS OPENED FOR SUTURING, THE TAIL OF THE NEEDLE WAS BROKEN. THEN THE NEEDLE DETACHED FROM THE WHOLE SUTURE. TO RESOLVE THE ISSUE, A NEW DEVICE WAS USED.

  Patient problems: Insufficient Information

  MAUDE report 17909368 ↗
• MalfunctionJul 28, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, IMMEDIATELY AFTER OPENING, THE WELDED PART OF THE THREAD AND THE NEEDLE DID NOT COME OFF, BUT IT CAME OFF AT THE FIRST STITCH. IT OCCURRED ON TWO ABSORBABLE SUTURES.

  Patient problems: Insufficient Information

  MAUDE report 17415376 ↗

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