V-Loc 180 VLOCL0013Recalls & reported problems
Covidien LP · Absorbable Wound Closure Device · Class 2 · Implant
All models of V-Loc 180 (61)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Covidien V-Loc 180 absorbable wound closure suture is used to close surgical wounds. The 28 reports mostly describe the needle breaking or detaching from the thread mid-procedure, with surgeons opening another package to finish; no deaths and no injuries are reported. One open recall, started in June 2026, covers possible tears in the sterile barrier packaging that could contaminate the suture and lead to infection.
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
- 27
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 10884521130364), received between Aug 2, 2017 and Sep 3, 2024 — classified as 27 malfunctions.
The most frequently reported specific device problem is “Break” (19 reports).
1 FDA recall record name this device's identifier, 1 still open.
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
Recalls naming this device
- Jun 24, 2026Class IIOpen, Classified
Product may contain a perforation or tear in the sterile barrier packaging. This issue may result in biocontamination of the sterile sutures, which may lead to infection, loss of vision if in ophthalmic utilization, or prolonged surgery.
Z-2919-2026 · Root cause: Equipment maintenance · Recall details · FDA record ↗
Most reported problems
Device problems
- Break19
- Detachment of Device or Device Component8
Patient problems
- No Known Impact Or Consequence To Patient15
- No Consequences Or Impact To Patient8
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 25 most recent of 27 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 3, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE NEEDLE DETACHED FROM THE STRAND. A NEW SUTURE WAS OPENED UNTIL THE SURGEON FINISHED THE SUTURING. A FEW PACKAGES HAD TO BE OPENED BEFORE A FLAWLESS SUTURE LASTED ALL THE WAY. THREE TO FOUR SUTURES HAD THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20130366 ↗MalfunctionSep 3, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE NEEDLE DETACHED FROM THE STRAND. A NEW SUTURE WAS OPENED UNTIL THE SURGEON FINISHED THE SUTURING. A FEW PACKAGES HAD TO BE OPENED BEFORE A FLAWLESS SUTURE LASTED ALL THE WAY. THREE TO FOUR SUTURES HAD THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20130226 ↗MalfunctionSep 3, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE NEEDLE DETACHED FROM THE STRAND. A NEW SUTURE WAS OPENED UNTIL THE SURGEON FINISHED THE SUTURING. A FEW PACKAGES HAD TO BE OPENED BEFORE A FLAWLESS SUTURE LASTED ALL THE WAY. THREE TO FOUR SUTURES HAD THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20130124 ↗MalfunctionSep 3, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE NEEDLE DETACHED FROM THE STRAND. A NEW SUTURE WAS OPENED UNTIL THE SURGEON FINISHED THE SUTURING. A FEW PACKAGES HAD TO BE OPENED BEFORE A FLAWLESS SUTURE LASTED ALL THE WAY. THREE TO FOUR SUTURES HAD THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20130034 ↗MalfunctionJul 9, 2020Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING THE GASTRIC LAPAROTOMY, THE NEEDLE DETACHED FROM THE THREAD. THE PRODUCT WAS NOT USED FOR THE PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10250878 ↗MalfunctionApr 8, 2020Break; Break
ACCORDING TO THE REPORTER, DURING A PROCEDURE, AT THE FIRST PACKAGE, THE THREAD BROKE. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9933779 ↗MalfunctionMar 3, 2020Break; Break
ACCORDING TO THE REPORTER, DURING THE PROCEDURE, WHILE USING THE DEVICE FOR DERMAL SUTURING, THE THREAD BROKE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9782105 ↗MalfunctionJan 9, 2020Break; Break
ACCORDING TO THE REPORTER, DURING A CESAREAN SECTION, IN DERMAL SUTURING, THE THREAD BROKE HALFWAY. WHEN THE REPORTED PRODUCT WAS CHECKED, IT WAS NOTED TO BE BROKEN FROM THE PLACE NEAR THE LOOP. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9568896 ↗MalfunctionNov 2, 2018Break; Break
ACCORDING TO THE REPORTER, DURING A DERMAL SUTURING, WHEN THE FIRST PRODUCT WAS USED, THE THREAD BROKE WHILE SUTURING. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8033372 ↗MalfunctionOct 22, 2018Break; Break
ACCORDING TO THE REPORTER, PRE-OPERATIVELY, THE DEVICE THREAD BROKE DURING SUTURING. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7991052 ↗MalfunctionOct 19, 2018Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A THYROIDECTOMY PROCEDURE, WHEN THE NEEDLE WAS ATTEMPTED TO BE TAKEN OUT FROM THE PACKET TO USE, THE NEEDLE AND THE THREAD WERE DISENGAGED AND THE PRODUCT WAS NOT ABLE TO USE IT. THEREFORE, A SUTURE WAS USED TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7984718 ↗MalfunctionAug 31, 2018Break; Break
ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE THREAD BROKE DURING DERMAL SUTURING. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7837364 ↗MalfunctionAug 31, 2018Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A GYNECOLOGICAL SURGERY, WHILE ON DERMAL SUTURING THE DEVICE THREAD DISENGAGED FROM THE NEEDLE. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7837344 ↗MalfunctionJul 10, 2018Break
ACCORDING TO THE REPORTER, INTRA OPERATIVELY, THE LOOP BROKE. A NEW DEVICE WAS USED TO COMPLETE THE CASE. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7673945 ↗MalfunctionJul 2, 2018Break; Break
ACCORDING TO THE REPORTER, DURING SUBCUTANEOUS SUTURING ON THE ESOPHAGUS, THE LOOP BROKE WHEN PASSING THE NEEDLE THROUGH THE LOOP. A NEW DEVICE WAS USED TO COMPLETE THE CASE. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7654381 ↗MalfunctionJun 29, 2018Break; Break
ACCORDING TO THE REPORTER, DURING A TRANS ABDOMINAL PRE PERITONEAL PROCEDURE, THE LOOP BROKE. A NEW DEVICE WAS USED TO COMPLETE THE CASE. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7651302 ↗MalfunctionJun 26, 2018Break; Break
ACCORDING TO THE REPORTER, PRE-OPERATIVELY, THE WELDED PART OF THE LOOP WAS BROKEN. A NEW DEVICE WAS USED TO COMPLETE THE CASE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7637660 ↗MalfunctionFeb 22, 2018Break; Break
ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE DEVICE LOOP WAS BROKEN. THE STATUS OF THE PATIENT WAS UNKNOWN.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7289506 ↗MalfunctionFeb 7, 2018Break; Break
ACCORDING TO THE REPORTER, DURING GYNECOLOGY PROCEDURE WHILE DOING DERMAL SUTURING, WHEN A DOCTOR LET THE NEEDLE THROUGH THE LOOP, THE LOOP BROKE. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. NO PATIENT INJURY REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7247358 ↗MalfunctionJan 12, 2018Break; Break
ACCORDING TO THE REPORTER, DURING A ARTIFICIAL HIP JOINT REPLACEMENT, THE DEVICE'S LOOP BROKE. ALSO, THERE WERE THREE PRODUCTS THAT HAD THE SAME PROBLEM IN A ROW. THEY USED ANOTHER DEVICE TO COMPLETE THE CASE AND RESOLVE THE ISSUE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7187384 ↗MalfunctionDec 5, 2017Break; Break
ACCORDING TO THE REPORTER, A DOCTOR LET THE NEEDLE THROUGH THE ROOP AND TIED IT UP THEN THE LOOP BROKE. THIS HAPPENED TWICE. NO INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7082217 ↗MalfunctionNov 17, 2017Break; Break
ACCORDING TO THE REPORTER, DURING THE PROCEDURE THE LOOP BROKE. THIS HAPPENED 3 TIMES. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO INJURY TO THE PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7042574 ↗MalfunctionNov 17, 2017Break; Break
ACCORDING TO THE REPORTER, THE LOOP BROKE. THIS HAPPENED 3 TIMES. NO INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7040833 ↗MalfunctionNov 14, 2017Break; Break
ACCORDING TO THE REPORTER, DURING SUTURING, THE LOOP BROKE WITHOUT ANY EXCESSIVE FORCE. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7028104 ↗MalfunctionNov 7, 2017Break; Break
ACCORDING TO THE REPORTER, THE LOOP WAS BROKEN. NO PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7005898 ↗
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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 · each recall links to the FDA recall notice
- 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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