V-Loc 180 VLOCL4636Recalls & reported problems
Covidien LP · Absorbable Wound Closure Device, HOS-12, 1x Green Strand · Class 2 · Implant
All models of V-Loc 180 (61)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10884521215481), received between Jul 28, 2017 and Jul 24, 2023 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Break” (2 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.
Most reported problems
Device problems
- Break2
- Detachment of Device or Device Component1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Insufficient Information1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 24, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A WOUND CLOSURE OR SURGICAL INCISION CLOSURE PROCEDURE, WHEN IT WAS UNPACKED, WHILE FASCIAL SUTURE WAS PERFORMED, THE SUTURE AND NEEDLE WERE DISCONNECTED FROM THE START. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 17381995 ↗MalfunctionApr 29, 2021Break; Break
ACCORDING TO THE REPORTER, DURING SKIN CLOSURE AFTER AN OPEN DISTAL PANCREATECTOMY, THE THREAD OF THE SUTURE BROKE. A NEW SUTURE WAS OPENED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11750546 ↗MalfunctionJul 28, 2017Break; Break
ACCORDING TO THE REPORTER: OCCURRED DURING AN ORTHOPEDIC SPINE SURGERY. THE PRODUCT WAS BEING USED FOR INCISION CLOSURE. WHILE SUTURING, THE THREAD BROKE. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT HARM. THE STATUS OF THE PATIENT IS NO PROBLEM.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6750057 ↗
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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- 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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