V-Loc 90 VLOCM0033Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10884521528444), received between Jul 24, 2017 and Jan 28, 2026 — classified as 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 28, 2026Break

  ACCORDING TO THE REPORTER, THE SUTURES APPEARED TO BE DEFECTIVE, AS IT WERE BREAKING.

  Patient problems: Insufficient Information

  MAUDE report 24205970 ↗
• MalfunctionJan 28, 2026Break

  ACCORDING TO THE REPORTER, THE SUTURES APPEARED TO BE DEFECTIVE, AS IT WERE BREAKING.

  Patient problems: Insufficient Information

  MAUDE report 24205964 ↗
• MalfunctionJan 31, 2024Break; Break

  ACCORDING TO THE REPORTER, IN AN OPEN CAESAREAN SECTION, IN THE BEGINNING OF THE PROCESS TO CLOSE THE WOUND USING THE CONTINUOUS SUTURING TECHNIQUE, THE THREAD BROKE. ONE EXTRA SUTURE WAS OPENED AND ALSO BROKE. A THIRD SUTURE FROM THE SAME LOT WAS OPENED TO CLOSE THE SKIN SUCCESSFULLY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18611572 ↗
• MalfunctionJan 31, 2024Break; Break

  ACCORDING TO THE REPORTER, IN AN OPEN CAESAREAN SECTION, IN THE BEGINNING OF THE PROCESS TO CLOSE THE WOUND USING THE CONTINUOUS SUTURING TECHNIQUE, THE THREAD BROKE. ONE EXTRA SUTURE WAS OPENED AND ALSO BROKE. A THIRD SUTURE FROM THE SAME LOT WAS OPENED TO CLOSE THE SKIN SUCCESSFULLY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18611566 ↗
• MalfunctionJun 20, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, WHILE SUTURING WOUND, THE NEEDLE THREAD BROKE. THE DEVICE WAS RETRACTED.

  Patient problems: Insufficient Information

  MAUDE report 14744835 ↗
• MalfunctionMay 5, 2022Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING THE OPEN BREAST PLASTIC SURGERY, WHILE SUTURING TISSUE, BOTH NEEDLE AND THREAD WHEN USING THE CONTINUOUS SUTURING TECHNIQUE. TO RESOLVE THE ISSUE, THE SURGEON REPLACED WITH A NEW ONE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14286502 ↗
• MalfunctionFeb 10, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, AFTER TAKING THE PACKAGE OUT PRE-OPERATIVELY, A SUTURE HAD BOTH NEEDLE AND THREAD BROKEN. AN ADDITIONAL NEW SUTURE USED WITHOUT ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11307888 ↗
• MalfunctionFeb 4, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, AFTER TAKING THE PACKAGE OUT PRIOR A GYNECOLOGICAL PROCEDURES, THREE SUTURES HAD BOTH NEEDLE AND THREAD BROKEN WHILE ANOTHER SUTURE HAD BROKEN THREAD. AN ADDITIONAL NEW SUTURE USED WITHOUT ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11278751 ↗
• MalfunctionFeb 20, 2019Break; Component Missing; Break; Component Missing

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY WHILE IMPLANTING A PACEMAKER, DURING CLOSING OF POCKET, THE THREAD PART OF THE SUTURE B ROKE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8355833 ↗
• MalfunctionJun 20, 2018Break; Break

  ACCORDING TO THE REPORTER, DURING CLOSING IN A ORTHOPEDIC PROCEDURE, WHEN THEY WERE SUTURING THE THREAD OF THE DEVICE BROKE. THEY OPENED A NEW DEVICE TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7621978 ↗
• MalfunctionApr 6, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, THE NEEDLE HAS PULLED OFF ON A NUMBER OF THE SUTURES THEY THEN OPENED ANOTHER SUTURE TO RESOLVE THE ISSUE. THERE WAS NO REPORTED PATIENT INVOLVEMENT AND OUTCOME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7405150 ↗
• MalfunctionApr 6, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, THE NEEDLE HAS PULLED OFF ON A NUMBER OF THE SUTURES. THERE WAS NO REPORTED PATIENT INVOLVEMENT AND OUTCOME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7402844 ↗
• MalfunctionMar 6, 2018Detachment 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 AN OPEN MASTECTOMY PROCEDURE. THE SUTURE WAS BEING USED FOR CLOSING THE SUB CUTIS. THE SURGEON WAS USING THE CONTINUOUS SUTURING TECHNIQUE. THE NEEDLE BROKE OFF THE THREAD INSIDE THE PATIENT. NOTHING WAS LEFT IN THE PATIENT CAVITY. IN ORDER TO RESOLVE THE ISSUE AND COMPLETE THE CASE, ANOTHER SUTURE WAS USED. THERE WAS NO PATIENT HARM. THE PATIENT OUTCOME IS ALIVE, NO INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7316208 ↗
• MalfunctionNov 30, 2017Break; Product Quality Problem; Break; Product Quality Problem

  ACCORDING TO THE REPORTER, THE LOOP DIDN'T EXIST. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THE STATUS OF THE PATIENT IS NO PROBLEM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7073477 ↗
• MalfunctionNov 10, 2017Break; Break

  ACCORDING TO THE REPORTER: OCCURRED DURING THE BREAST AUGMENTATION PROCEDURE WHILE CLOSURING SUBCUTICULAR TISSUE, THE LOOP BROKE. TO RESOLVE THE ISSUE AND COMPLETE THE CASE, THE DEVICE WAS REMOVED AND ANOTHER ONE USED. NO KNOWN IMPACT OR CONSEQUENCE TO PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7017631 ↗
• MalfunctionSep 25, 2017Break; Break

  ACCORDING TO THE REPORTER, THE SUTURE HAD A LOOP ATTACHMENT AT THE END OF SUTURE, IT DID NOT HOLD AGAINST PRESSURE WHEN BEING USED WHILE CLOSING OF PATIENT. A NEW DEVICE WAS USED WITHOUT AN ISSUE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6890334 ↗
• MalfunctionJul 24, 2017Break; Break

  ACCORDING TO THE REPORTER: OCCURRED DURING SKIN CLOSURE FOLLOWING AN OPEN MASTECTOMY. THE LOOP BROKE AS THE SUTURE WAS PULLED TIGHT. A NEW SUTURE WAS USED TO COMPLETE THE PROCEDURE WITH NO ISSUES. THE PATIENT STATUS IS ALIVE WITH NO INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6736386 ↗

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