V-Loc 90 VLOCM0114Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 10884521131750), received between Aug 16, 2017 and Sep 22, 2026 — classified as 1 injury, 17 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 22, 2026Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  Patient problems: Post Operative Wound Infection

  MAUDE report 50860053 ↗
• MalfunctionSep 22, 2026Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  Patient problems: Post Operative Wound Infection

  MAUDE report 50860051 ↗
• MalfunctionSep 22, 2026Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  Patient problems: Post Operative Wound Infection

  MAUDE report 50860048 ↗
• MalfunctionSep 22, 2026Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  Duplicate of 709358240

  Patient problems: Post Operative Wound Infection

  MAUDE report 50860007 ↗
• InjurySep 22, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection

  MAUDE report 50859970 ↗
• MalfunctionJul 11, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A BILATERAL MASTECTOMY OPEN PROCEDURE, THE NEEDLE BREAKING OFF THE SWAGE WHILE SUTURING. THE NEEDLE DID NOT FALL INTO THE PATIENT CAVITY. AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS ARESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22487410 ↗
• MalfunctionJul 10, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE NEEDLE CAME LOOSE FROM THE STRAND. ANOTHER SUTURE FROM THE SAME BATCH WAS TRIED AND THE NEEDLE WAS FOUND TO BE LOOSE BEFORE USE. THE PHYSICIAN THEN USED A NORMAL NYLON SUTURE TO COMPLETE THE CLOSURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22472361 ↗
• MalfunctionMar 23, 2022Break; Break

  ACCORDING TO THE REPORTER, WHEN THE DEVICE WAS OPENED PRIOR TO USE, THE NEEDLE OF THE DEVICE BROKE. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13870068 ↗
• MalfunctionFeb 15, 2022Break; Break

  ACCORDING TO THE REPORTER, FOLLOWING A SPINAL CORD PAIN STIMULATOR IMPLANT, ONE OF THE THREAD BROKE AND PROTRUDED OUT OF THE INCISION LINE; AND THE OTHER SUTURE AND THE SKIN ADHESIVE HAD AN UNKNOWN ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13536699 ↗
• MalfunctionJul 23, 2021Break; Break

  ACCORDING TO THE REPORTER, WHILE PERFORMING A CONTINUOUS SUTURING WHILE CLOSING THE SKIN IN A SHOULDER ARTHROSCOPY, THE NEEDLE BROKE. SURGEON USED ANOTHER SUTURE TO RESOLVE THE ISSUE. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12217094 ↗
• MalfunctionOct 8, 2019Break; Break

  ACCORDING TO THE REPORTER, ON AN OPEN SILICONE BREAST PROSTHESIS SURGICAL IMPLANT PROCEDURE, DURING THE SUBCUTANEOUS SUTURE USING THE CONTINUOUS SUTURING TECHNIQUE, THE THREAD BROKE. ANOTHER TYPE OF DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9168060 ↗
• MalfunctionOct 12, 2018Break; Break

  ACCORDING TO THE REPORTER, DURING A SKIN CLOSURE, THE SUTURE BROKE WHILE THEY WHERE ANCHORING IT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7962853 ↗
• MalfunctionJul 24, 2018Break; Loose or Intermittent Connection; Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A HYSTERECTOMY PROCEDURE, AT THE START OF WOUND CLOSURE, BOTH THE NEEDLE AND THE THREAD BROKE. THE LOOP WHERE THE NEEDLE IS ATTACHED TO THE THREAD CAME LOOSE WHEN THE SURGEON WANTED TO USE IT. A NEW DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7714688 ↗
• MalfunctionApr 26, 2018Break; Break

  ACCORDING TO THE REPORTER, DURING SKIN CLOSURE ON A TOTAL HIP REPLACEMENT, THE SUTURE THREAD BROKE AFTER TAKING JUST TWO ¿BITES". THERE WAS NO EXCESSIVE FORCE ON THE SUTURE AND THE SUTURE BROKE VERY EASILY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7465020 ↗
• MalfunctionFeb 26, 2018Break; Break

  ACCORDING TO THE REPORTER, AT THE END OF THE PROCEDURE DURING SKIN CLOSURE, THE DEVICE'S THREAD BROKE. THE DEVICE HAS BEEN OPENED OR REMOVED FROM THE PACKAGING JUST BEFORE ITS USE. THEY USED ANOTHER DEVICE TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7296319 ↗
• MalfunctionDec 6, 2017Break; Break

  ACCORDING TO THE REPORTER, DURING MASTECTOMY- SKIN CLOSURE PROCEDURE, THREE DEVICES WERE USED AND THEIR THREAD BROKE. THE SURGEON USED CONTINUOUS SUTURING TECHNIQUE. THEY USED ANOTHER SUTURE IN ORDER TO COMPLETE THE CASE. THERE WAS NO INJURY CAUSED TO THE PATIENT AND NO MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7089529 ↗
• MalfunctionAug 18, 2017Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, ON (B)(6) 2017, INTRA-OPERATIVELY IN A PACEMAKER PLACEMENT, THE DEVICE KEPT BREAKING WHILE SUTURING, ONE PRODUCT WAS ALREADY DETACHED FROM THE STRAND. THE PATIENT WAS ALIVE WITH NO INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6803647 ↗
• MalfunctionAug 16, 2017Break; Break

  ACCORDING TO THE REPORTER, DURING SUTURING, THE LOOP BROKE WITHOUT BEING PULLED STRONGLY. NO HARM WAS CAUSED TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6798677 ↗

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