V-Loc 90 VLOCM0134Recalls & 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 suture has 41 adverse event reports, including 40 malfunctions and 1 injury: reports mostly describe the suture breaking midway during suturing, sometimes with the needle pulling off the thread, and a replacement suture used. No deaths occurred and no recalls name this device. Reports dropped sharply to 0 in the last 12 months from 29 in the prior 12 months.
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
- 41
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 41 adverse event reports that list this exact device (DI 10884521132276), received between Aug 14, 2017 and Jul 16, 2025 — classified as 1 injury, 40 malfunctions.
The most frequently reported specific device problem is “Break” (34 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
- Break34
- Detachment of Device or Device Component5
- Adverse Event Without Identified Device or Use Problem1
- Component Missing1
Patient problems
- No Clinical Signs, Symptoms or Conditions32
- No Known Impact Or Consequence To Patient3
- No Patient Involvement3
- No Consequences Or Impact To Patient2
- Insufficient Information1
- Laceration(s)1
- Obstruction/Occlusion1
Recent adverse event reports
The 25 most recent of 41 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 16, 2025Break; Break
IT WAS REPORTED THAT DURING SUTURING, THE LOOP BROKE AND THE SUTURE ALSO BROKE IN THE MIDDLE. AN ADDITIONAL NEW SUTURE FROM ANOTHER MANUFACTURER 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 22523313 ↗MalfunctionMay 15, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A PROCEDURE, AT FIRST STITCH, THE NEEDLE PULLED OFF THE THREAD. IT BECAME UNUSABLE. TO RESOLVE THE ISSUE, A NEW SUTURE WAS USED. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22031200 ↗MalfunctionApr 4, 2025Break; Break
IT WAS REPORTED THAT DURING A PROCEDURE ON SEVEN DEVICES, THE SUTURE BROKE IN THE MIDDLE WHILE SUTURING. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21778655 ↗MalfunctionApr 4, 2025Break; Break
IT WAS REPORTED THAT DURING A PROCEDURE ON SEVEN DEVICES, THE SUTURE BROKE IN THE MIDDLE WHILE SUTURING. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21778650 ↗MalfunctionApr 4, 2025Break; Break
IT WAS REPORTED THAT DURING A PROCEDURE ON SEVEN DEVICES, THE SUTURE BROKE IN THE MIDDLE WHILE SUTURING. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21778648 ↗MalfunctionApr 4, 2025Break; Break
IT WAS REPORTED THAT DURING A PROCEDURE ON SEVEN DEVICES, THE SUTURE BROKE IN THE MIDDLE WHILE SUTURING. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21778640 ↗MalfunctionApr 4, 2025Break; Break
IT WAS REPORTED THAT DURING A PROCEDURE ON SEVEN DEVICES, THE SUTURE BROKE IN THE MIDDLE WHILE SUTURING. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21778634 ↗MalfunctionMar 11, 2025Break; Break
ACCORDING TO THE REPORTER, DURING A PROCEDURE, WHILE SUTURING, THE SUTURE BROKE IN THE MIDDLE. THE ISSUE OCCURRED ON FIVE SUTURES. ANOTHER SUTURE FROM OTHER MANUFACTURER WAS USED TO RESOLVE THE ISSUE. THERE WAS EXTENDED SURGICAL TIME FOR 30 MINUTES AND SUTURING LINE GOT DISRUPTED IN PATIENT. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21576014 ↗MalfunctionMar 11, 2025Break; Break
ACCORDING TO THE REPORTER, DURING A PROCEDURE, WHILE SUTURING, THE SUTURE BROKE IN THE MIDDLE. THE ISSUE OCCURRED ON FIVE SUTURES. ANOTHER SUTURE FROM OTHER MANUFACTURER WAS USED TO RESOLVE THE ISSUE. THERE WAS EXTENDED SURGICAL TIME FOR 30 MINUTES AND SUTURING LINE GOT DISRUPTED IN PATIENT. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21575984 ↗MalfunctionMar 11, 2025Break; Break
ACCORDING TO THE REPORTER, DURING A PROCEDURE, WHILE SUTURING, THE SUTURE BROKE IN THE MIDDLE. THE ISSUE OCCURRED ON FIVE SUTURES. ANOTHER SUTURE FROM OTHER MANUFACTURER WAS USED TO RESOLVE THE ISSUE. THERE WAS EXTENDED SURGICAL TIME FOR 30 MINUTES AND SUTURING LINE GOT DISRUPTED IN PATIENT. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21575981 ↗MalfunctionMar 11, 2025Break; Break
ACCORDING TO THE REPORTER, DURING A PROCEDURE, WHILE SUTURING, THE SUTURE BROKE IN THE MIDDLE. THE ISSUE OCCURRED ON FIVE SUTURES. ANOTHER SUTURE FROM OTHER MANUFACTURER WAS USED TO RESOLVE THE ISSUE. THERE WAS EXTENDED SURGICAL TIME FOR 30 MINUTES AND SUTURING LINE GOT DISRUPTED IN PATIENT. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21575878 ↗MalfunctionMar 11, 2025Break; Break
ACCORDING TO THE REPORTER, DURING A PROCEDURE, WHILE SUTURING, THE SUTURE BROKE IN THE MIDDLE. THE ISSUE OCCURRED ON FIVE SUTURES. ANOTHER SUTURE FROM OTHER MANUFACTURER WAS USED TO RESOLVE THE ISSUE. THERE WAS EXTENDED SURGICAL TIME FOR 30 MINUTES AND SUTURING LINE GOT DISRUPTED IN PATIENT. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21575831 ↗MalfunctionMar 10, 2025Break; Break
IT WAS REPORTED THAT DURING A PROCEDURE, THERE WAS MORE THAN ONE DEFECTIVE DEVICE INVOLVED; THE SUTURE BROKE IN THE MIDDLE WHILE SUT URING. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21560777 ↗MalfunctionMar 10, 2025Break; Break
IT WAS REPORTED THAT DURING A PROCEDURE, THERE WAS MORE THAN ONE DEFECTIVE DEVICE INVOLVED; THE SUTURE BROKE IN THE MIDDLE WHILE SUT URING. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21560579 ↗MalfunctionFeb 18, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT WHILE CLOSING, THE SUTURES WERE SNAPPING OFF THE NEEDLE ON BOTH VERSIONS OF VLOC AND POLYSORB ABSORBABLE SUTURES. MORE SUTURES WERE OPENED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21406895 ↗MalfunctionFeb 18, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT WHILE CLOSING, THE SUTURES WERE SNAPPING OFF THE NEEDLE ON BOTH VERSIONS OF VLOC AND POLYSORB ABSORBABLE SUTURES. MORE SUTURES WERE OPENED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21405692 ↗MalfunctionJan 24, 2025Break; Break
ACCORDING TO THE REPORTER, DURING A BILATERAL TOTAL KNEE REPLACEMENT, WHILE SUTURING, THE MIDDLE OF THE SUTURE BROKE. IT WAS NOTED THAT FOUR SUTURES HAD THE SAME ISSUE. THE SURGICAL TIME WAS EXTENDED BY FIFTEEN MINUTES. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21231584 ↗MalfunctionJan 24, 2025Break; Break
ACCORDING TO THE REPORTER, DURING A BILATERAL TOTAL KNEE REPLACEMENT, WHILE SUTURING, THE MIDDLE OF THE SUTURE BROKE. IT WAS NOTED THAT FOUR SUTURES HAD THE SAME ISSUE. THE SURGICAL TIME WAS EXTENDED BY FIFTEEN MINUTES. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21231575 ↗MalfunctionJan 24, 2025Break; Break
ACCORDING TO THE REPORTER, DURING A BILATERAL TOTAL KNEE REPLACEMENT, WHILE SUTURING, THE MIDDLE OF THE SUTURE BROKE. IT WAS NOTED THAT FOUR SUTURES HAD THE SAME ISSUE. THE SURGICAL TIME WAS EXTENDED BY FIFTEEN MINUTES. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21231562 ↗MalfunctionJan 24, 2025Break; Break
ACCORDING TO THE REPORTER, DURING A BILATERAL TOTAL KNEE REPLACEMENT, WHILE SUTURING, THE MIDDLE OF THE SUTURE BROKE. IT WAS NOTED THAT FOUR SUTURES HAD THE SAME ISSUE. THE SURGICAL TIME WAS EXTENDED BY FIFTEEN MINUTES. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21231554 ↗MalfunctionJan 24, 2025Break; Break
ACCORDING TO THE REPORTER, DURING A BILATERAL TOTAL KNEE REPLACEMENT, WHILE SUTURING, THE MIDDLE OF THE SUTURE BROKE. IT WAS NOTED THAT FOUR SUTURES HAD THE SAME ISSUE. THE SURGICAL TIME WAS EXTENDED BY FIFTEEN MINUTES. THE USER REPLACED THE DEVICE TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21229803 ↗MalfunctionJan 24, 2025Break; Break
ACCORDING TO THE REPORTER, DURING A BILATERAL TOTAL KNEE REPLACEMENT, WHILE SUTURING, THE MIDDLE OF THE SUTURE BROKE. IT WAS NOTED THAT FOUR SUTURES HAD THE SAME ISSUE. THE SURGICAL TIME WAS EXTENDED BY FIFTEEN MINUTES. THE USER REPLACED THE DEVICE TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21229779 ↗MalfunctionJan 24, 2025Break; Break
ACCORDING TO THE REPORTER, DURING A BILATERAL TOTAL KNEE REPLACEMENT, WHILE SUTURING, THE MIDDLE OF THE SUTURE BROKE. IT WAS NOTED THAT FOUR SUTURES HAD THE SAME ISSUE. THE SURGICAL TIME WAS EXTENDED BY FIFTEEN MINUTES. THE USER REPLACED THE DEVICE TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21229750 ↗MalfunctionJan 24, 2025Break; Break
ACCORDING TO THE REPORTER, DURING A BILATERAL TOTAL KNEE REPLACEMENT, WHILE SUTURING, THE MIDDLE OF THE SUTURE BROKE. IT WAS NOTED THAT FOUR SUTURES HAD THE SAME ISSUE. THE SURGICAL TIME WAS EXTENDED BY 15 MINUTES. THE USER REPLACED THE DEVICE TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21229727 ↗MalfunctionJan 24, 2025Break; Break
ACCORDING TO THE REPORTER, DURING A BILATERAL TOTAL KNEE REPLACEMENT, WHILE SUTURING, THE MIDDLE OF THE SUTURE BROKE. IT WAS NOTED THAT FOUR SUTURES HAD THE SAME ISSUE. THE SURGICAL TIME WAS EXTENDED. THE USER REPLACED THE DEVICE TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21229590 ↗
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
- Coated VICRYL VCP433HEthicon, LLC · SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID1 death1,093 reports
- Polysorb CL-915Covidien LP · SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID503 reports
- 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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