V-Loc 180 VLOCL0124Recalls & 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
- Adverse event reports
- 18
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 10884521130555), received between Feb 1, 2018 and Feb 6, 2026 — classified as 18 malfunctions.
The most frequently reported specific device problem is “Break” (15 reports).
1 other recall cover devices cleared under the same FDA submission (K091087); 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
- Break15
- Detachment of Device or Device Component6
Patient problems
- No Known Impact Or Consequence To Patient7
- No Clinical Signs, Symptoms or Conditions5
- No Consequences Or Impact To Patient3
- No Information2
- Insufficient Information1
- No Patient Involvement1
Recent adverse event reports
The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 6, 2026Break
ACCORDING TO THE REPORTER, DURING A TOTAL HYSTERECTOMY PROCEDURE, AT THE TIME OF WOUND CLOSURE OR SURGICAL INCISION CLOSURE, THE SUTURE WAS DAMAGED AT THE CENTER. IT OCCURRED ON TWO SUTURES. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24280805 ↗MalfunctionFeb 6, 2026Break
ACCORDING TO THE REPORTER, DURING A TOTAL HYSTERECTOMY PROCEDURE, AT THE TIME OF WOUND CLOSURE OR SURGICAL INCISION CLOSURE, THE SUTURE WAS DAMAGED AT THE CENTER. IT OCCURRED ON TWO SUTURES. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24280768 ↗MalfunctionAug 5, 2025Break; Break
IT WAS REPORTED THAT DURING THE SUTURING OF THE SUBCUTANEOUS TISSUE, THE THREAD BROKE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22723310 ↗MalfunctionNov 27, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, PREOPERATIVELY, AFTER OPENING, IT WAS FOUND THAT BOTH NEEDLE AND THREAD RUPTURED AND WAS DISCONNECTED FROM THE NEEDLE. THE SURGEON USED ANOTHER DEVICE TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18210661 ↗MalfunctionDec 8, 2020Break; Break
ACCORDING TO THE REPORTER, DURING INCISION CLOSURE ON AN OPEN ABDOMINAL SURGERY, THE THREAD BROKE. ANOTHER SUTURE WAS USED TO COMPLETE THE CASE.
Patient problems: Insufficient Information
MAUDE report 10964939 ↗MalfunctionSep 4, 2020Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, INTRAOPERATIVELY, WHEN TRYING TO USE, THE NEEDLE CAME OFF IMMEDIATELY FROM THE PROXIMAL PART OF THE PRODUCT AND WAS UNABLE TO BE USED. THE SAME KIND OF PRODUCT WAS TAKEN OUT AND THE SURGERY WAS COMPLETED WITHOUT PROBLEMS. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient
MAUDE report 10492900 ↗MalfunctionDec 30, 2019Break; Break
ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC SKIN CLOSURE PROCEDURE, THE DEVICE THREAD BROKE. IT WAS BROKEN BEFORE THE PACKAGE HAD OPENED.
Patient problems: No Information
MAUDE report 9529906 ↗MalfunctionOct 16, 2019Break; Break
ACCORDING TO THE REPORTER, PRIOR TO A PROCEDURE, THE SUTURE OF THE DEVICE BROKE. A NEW SUTURE WAS USED FROM THE SAME BOX WITHOUT ISSUE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 9200341 ↗MalfunctionJun 28, 2019Break; Break
ACCORDING TO THE REPORTER, AT THE TIME OF SUBCUTANEOUS SUTURE DURING TOTAL KNEE ARTHROPLASTY (TKA), SIX (6) SUTURES BROKE IMMEDIATELY AFTER GETTING THROUGH THE LOOP. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8744403 ↗MalfunctionApr 24, 2019Break; Break
ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE SUTURE BROKE. THERE WAS NO PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8543906 ↗MalfunctionMar 28, 2019Break; Break
ACCORDING TO THE REPORTER, DURING SURGERY, THE SUTURE BROKE.
Patient problems: No Information
MAUDE report 8462707 ↗MalfunctionOct 12, 2018Break; Break
ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE DEVICE NEEDLE BROKE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7960079 ↗MalfunctionMay 21, 2018Break; Break
ACCORDING TO THE REPORTER, DURING AN OPEN PROCEDURE, WHEN THE SURGEON WAS PERFORMING A RUNNING STITCH, THE THREAD BROKE. ANOTHER SUTURE WAS TAKEN TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7530071 ↗MalfunctionMar 29, 2018Break; Break
ACCORDING TO THE REPORTER, IMMEDIATE AFTER THE START OF USE, THE LOOP BROKE IN A ROW. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7383153 ↗MalfunctionMar 8, 2018Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A PROCEDURE, THREE OF THE PRODUCTS, THE LOOP BROKE AND ON A FOURTH PRODUCT, THE NEEDLE HAD DETACHED FROM THE SUTURE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT INJURY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7324764 ↗MalfunctionMar 7, 2018Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, PRIOR TO USE, THE NEEDLE DETACHED. THERE WAS NO REPORTED PATIENT HARM.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7321609 ↗MalfunctionMar 2, 2018Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE THREE OF THE PRODUCTS, THE LOOP BROKE AND ON A FOURTH PRODUCT, THE NEEDLE HAD DET ACHED FROM THE SUTURE. THERE WAS NO PATIENT INJURY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7309338 ↗MalfunctionFeb 1, 2018Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE THREE OF THE PRODUCTS, THE LOOP BROKE AND ON A FOURTH PRODUCT, THE NEEDLE HAD DET ACHED FROM THE SUTURE. THERE WAS NO PATIENT INJURY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7233828 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K091087. One submission often covers many models, so check the product and lot details in each record.
- Z-2919-2026 · Jun 24, 2026 · Open, ClassifiedV-Loc 180 Absorbable Wound Closure Device BOX BEDSIDE STAPLING IS KING BOX06614V4 BOX BY PASS FINAL BOX07405V1 BOX BYPASS CARDON BOX01056V2 BOX BYPASS DR LAGAE BOX0
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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
- 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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