V-Loc 90 VLOCM2105Recalls & reported problems
Covidien LP · Absorbable Wound Closure Device · Class 2 · Implant
All models of V-Loc 90 (56)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Covidien V-Loc 90 absorbable barbed suture is used to close surgical wounds. The 38 reports mostly describe the suture breaking during surgery or while being unpacked, and the thread detaching from the needle, which sometimes slowed or prolonged the operation. There are no deaths and 1 injury. Reports dropped from 8 in the previous 12 months to 2 in the most recent 12 months. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 40
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 40 adverse event reports that list this exact device (DI 10884521132993), received between Oct 20, 2017 and Sep 23, 2026 — classified as 2 injuries, 38 malfunctions.
The most frequently reported specific device problem is “Break” (24 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.
Reports received per month
Most reported problems
Device problems
- Break24
- Detachment of Device or Device Component14
- Difficult to Open or Close1
- Difficult to Remove1
- Unraveled Material1
- Use of Device Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions21
- Insufficient Information6
- No Consequences Or Impact To Patient5
- No Known Impact Or Consequence To Patient5
- Foreign Body In Patient2
- Unintended Radiation Exposure2
- No Information1
- No Patient Involvement1
Recent adverse event reports
The 25 most recent of 40 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 23, 2026Detachment of Device or Device Component
It was reported that during a procedure, the needle detached while suturing and preparing the suture after the patient incision. A search was carried out in the cavity for 10 to 15 minutes; as a result, the surgical time was extended by 10 to 15 minutes. There was no patient injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50864593 ↗InjuryJun 19, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A ROBOTIC LAPAROSCOPIC PROCEDURE, THE NEEDLE BROKE OFF AT THE CONNECTION OF THE NEEDLE AND THREAD WHILE SUTURING. AN X-RAY WAS PERFORMED TO LOCATE THE NEEDLE, AND THE NEEDLE WAS FOUND; HOWEVER, THE SURGEON WAS UNABLE TO RETRIEVE IT AND THE PATIENT WAS CLOSED WITH THE NEEDLE REMAINING IN THE PATIENT. THE PROCEDURE EXTENDED BY APPROXIMATELY 3 HOURS WHILE SEARCHING FOR THE MISSING NEEDLE.
Patient problems: Foreign Body In Patient; Insufficient Information; Unintended Radiation Exposure
MAUDE report 25563488 ↗MalfunctionApr 27, 2026Use of Device Problem
ACCORDING TO THE REPORTER IN A ROBOT ASSISTED LAPAROSCOPIC HYSTERECTOMY, DURING VAGINAL VAULT CLOSURE, THE SUTURE WOULD NOT PULL THROUGH THE TISSUE IN THE USUAL MANNER AFTER THE FIRST PASS THROUGH BOTH SIDES OF PATIENT¿S VAGINAL VAULT. THE SUTURE WOULD NOT TIGHTEN. ANOTHER SUTURE WAS USED TO COMPLETE THE CASE. THE ISSUE RESULTED TO PROLONGED SURGICAL TIME.
Patient problems: Insufficient Information
MAUDE report 24994132 ↗MalfunctionMar 30, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A LAPAROSCOPIC UMBILICAL HERNIOPLASTY, WHILE PLACING THE FIRST STITCH INSIDE THE PATIENT'S CAVITY AND WHEN PULLING THE BODY OF THE NEEDLE, THE THREAD DETACHED FROM THE SWAGED AREA. THE PHYSICIAN THEN REMOVED BOTH THE NEEDLE AND THE THREAD FROM INSIDE THE CAVITY. 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 24708714 ↗MalfunctionAug 11, 2025Break; Break
ACCORDING TO THE REPORTER, THE TWO NEEDLES BROKE.
Patient problems: Insufficient Information
MAUDE report 22779191 ↗MalfunctionJul 28, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A GYNECOLOGICAL ROBOT PROCEDURE, THE SUTURE CAME LOOSE.
Patient problems: Insufficient Information
MAUDE report 22638801 ↗MalfunctionFeb 25, 2025Break; Break
IT WAS REPORTED THAT DURING A LAPAROSCOPIC OVARIAN TUMOR RESECTION, UPON OPENING THE ALUMINUM PACK TO USE THE BARBED SUTURE, THE LOOP AT THE END OF THE SUTURE WAS FOUND TO BE DAMAGED DUE TO IMPROPER WELDING, SO IT COULD NOT BE USED FOR CLINICAL USE. SINCE THIS DEFECT WAS DISCOVERED DURING PREPARATION BEFORE PATIENT USE, THE PATIENT WAS NOT DIRECTLY AFFECTED. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21464258 ↗MalfunctionFeb 4, 2025Break; Break
IT WAS REPORTED THAT THE TWO SUTURES BROKE WHILE BEING REMOVED FROM THE RETAINER AND PREPARED PRIOR TO PATIENT INCISION. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21304633 ↗MalfunctionFeb 4, 2025Break; Break
IT WAS REPORTED THAT THE TWO SUTURES BROKE WHILE BEING REMOVED FROM THE RETAINER AND PREPARED PRIOR TO PATIENT INCISION. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21304579 ↗MalfunctionNov 22, 2024Break; Break
ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE TWO SUTURE NEEDLE BREAK OFF. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20759167 ↗MalfunctionNov 22, 2024Break; Break
ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE TWO SUTURE NEEDLE BREAK OFF. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20759128 ↗MalfunctionNov 5, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, THE FIRST SUTURE BROKE AFTER THE FIRST STITCH (WITH NO PARTICULAR TRACTION OR SEWING).
Patient problems: Insufficient Information
MAUDE report 20613479 ↗MalfunctionOct 29, 2024Break; Break
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC HYSTERECTOMY PROCEDURE, THE FIRST SUTURE, THE NEEDLE DISENGAGED FROM THE THREAD UPON INTRODUCTION. THE SECOND SUTURE CAME LOOSE FROM THE NEEDLE WHEN IT WAS REMOVED FROM ITS PACKAGING. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20559975 ↗MalfunctionAug 15, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE NEEDLE OF TWO SUTURES DETACHED FROM THE THREAD. NO DEVICE COMPONENT FELL INTO THE PATIENT¿S CAVITY. ANOTHER SUTURE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19995904 ↗MalfunctionAug 15, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE NEEDLE OF TWO SUTURES DETACHED FROM THE THREAD. NO DEVICE COMPONENT FELL INTO THE PATIENT¿S CAVITY. ANOTHER SUTURE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19995755 ↗MalfunctionFeb 15, 2024Break; Break
ACCORDING TO THE REPORTER, DURING A TOTAL LAPAROSCOPIC HYSTERECTOMY, WHEN SEWING THE VAGINAL CUFF, THE THREAD OF THE TWO SUTURES BROKE. THE PATIENT DID NOT EXPERIENCE ANY PROBLEMS BECAUSE THE SURGEON CONTINUED WITH ANOTHER PRODUCT TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18717269 ↗MalfunctionFeb 15, 2024Break; Break
ACCORDING TO THE REPORTER, DURING A TOTAL LAPAROSCOPIC HYSTERECTOMY, WHEN SEWING THE VAGINAL CUFF, THE THREAD OF THE TWO SUTURES BROKE. THE PATIENT DID NOT EXPERIENCE ANY PROBLEMS BECAUSE THE SURGEON CONTINUED WITH ANOTHER PRODUCT TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18717121 ↗InjuryJan 18, 2024Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC BARIATRIC GASTRIC BYPASS PROCEDURE, WHILE REMOVING THE SUTURE FROM THE ABDOMEN AFTER PERFORMING AN ANASTOMOSES, THE NEEDLE CAME LOOSE AND AND GOT LOST IN THE PATIENT'S CAVITY. AN X-RAY WAS PERFORMED IN THE THEATRE WITH NO SUCCESS. THE PATIENT WAS THEN WAKEN UP AND TAKEN TO THE X-RAY DEPARTMENT WHERE THE POSITION OF THE NEEDLE WAS IDENTIFIED. THE PATIENT WAS TAKEN BACK TO THE THEATRE TO REMOVE IT.
Patient problems: Foreign Body In Patient; Unintended Radiation Exposure
MAUDE report 18534587 ↗MalfunctionSep 14, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A ROBOTIC LAPAROSCOPIC PROCEDURE, THE NEEDLE POPPED OFF.
Patient problems: Insufficient Information
MAUDE report 17748854 ↗MalfunctionJul 7, 2023Break; Break
ACCORDING TO THE REPORTER, DURING ROBOTIC LAPAROSCOPIC GASTRIC SLEEVE, WHEN USER GRABBED THE SUTURE WITH THE ROBOTIC ARM, THE THREAD BROKE. THIS HAPPENED TO TWO MORE SUTURES FROM THE SAME LOT. NO COMPONENT FELL INTO THE PATIENT. TO RESOLVE THE ISSUE, ANOTHER SUTURE FROM A DIFFERENT LOT WAS USED. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17282822 ↗MalfunctionApr 10, 2023Break; Break
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC HERNIOPLASTY, WHEN PERITONEAL SUTURE WAS PERFORMED, FOUR SUTURES WERE USED WITH THE SAME LOT BUT THE THREAD WAS BREAKING. WITH THE FIFTH SUTURE, THE PERITONEUM COULD BE SUTURED CORRECTLY. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16708437 ↗MalfunctionApr 10, 2023Break; Break
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC HERNIOPLASTY, WHEN PERITONEAL SUTURE WAS PERFORMED, FOUR SUTURES WERE USED WITH THE SAME LOT BUT THE THREAD WAS BREAKING. WITH THE FIFTH SUTURE, THE PERITONEUM COULD BE SUTURED CORRECTLY. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16708411 ↗MalfunctionApr 10, 2023Break; Break
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC HERNIOPLASTY, WHEN PERITONEAL SUTURE WAS PERFORMED, FOUR SUTURES WERE USED WITH THE SAME LOT BUT THE THREAD WAS BREAKING. WITH THE FIFTH SUTURE, THE PERITONEUM COULD BE SUTURED CORRECTLY. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16708383 ↗MalfunctionMar 28, 2023Break; Break
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC HERNIOPLASTY, WHEN PERITONEAL SUTURE WAS PERFORMED, FOUR SUTURES WERE USED WITH THE SAME LOT BUT THE THREAD WAS BREAKING. WITH THE FIFTH SUTURE, THE PERITONEUM COULD BE SUTURED CORRECTLY. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16630065 ↗MalfunctionJan 27, 2022Break; Break
ACCORDING TO THE REPORTER, DURING A PROCEDURE, WHILE CLOSING SKIN, 2 SUTURE THREADS BROKE. ADDITIONAL SUTURE WAS UTILIZED TO COMPLETE THE CASE AND RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13368162 ↗
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, ClassifiedV-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
Other SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID devices
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- Coated VICRYL VCP493HEthicon, LLC · SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID435 reports
- V-Loc 180 VLOCL0316Covidien LP · SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID1 recall376 reports
- Coated VICRYL VCP345HEthicon, LLC · SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID1 death405 reports
- V-Loc 180 VLOCL0604Covidien LP · SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID1 recall328 reports
- V-Loc 180 VLOCA008LCovidien LP · SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID1 recall294 reports
- V-Loc 180 VLOCL0326Covidien LP · SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID330 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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