V-Loc 180 VLOCL2836Recalls & reported problems
Covidien LP · Absorbable Wound Closure Device, GS-11, 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
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10884521214729), received between May 18, 2018 and Feb 6, 2026 — classified as 5 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.
Reports received per month
Most reported problems
Device problems
- Break2
- Detachment of Device or Device Component2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Foreign Body In Patient1
- No Consequences Or Impact To Patient1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 6, 2026Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A PROCEDURE, WHEN SUTURING, THE NEEDLE WAS DETACHED. A NEW SUTURE WAS USED WITHOUT ANY PROBLEMS. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24280652 ↗MalfunctionJan 27, 2026
WHILE SUTURING VAGINAL CUFF AFTER LAPAROSCOPIC VAGINAL ASSISTED HYSTERECTOMY, WITH 2-0 V-LOC SUTURE, THE NEEDLE BROKE IN TWO PARTS, SURGEON WAS ABLE TO RETRIEVE ONE PART OF THE SUTURE NEEDLE. THEY LOOKED FOR THE OTHER NEEDLE PORTION, BUT IT WAS NOT FOUND WITHIN PATIENT. RETAINED NEEDLE PORTION SEEN IN ABDOMEN ON X-RAY. DECISION WAS MADE RETAIN NEEDLE SEGMENT AS FELT THERE WAS NO WAY TO SAFELY REMOVE IT. VENDOR INFORMED. MANUFACTURER RESPONSE FOR SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID, V-LOC 180 (PER SITE REPORTER).
Patient problems: Foreign Body In Patient
MAUDE report 24188558 ↗MalfunctionJul 5, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, PRIOR TO USE, WHEN THE NURSE OPENED THE PACKAGE AND TOOK OUT THE NEEDLE, THE NEEDLE AND THREAD HAD ALREADY COME OFF. A NEW ONE WAS TAKEN OUT AND USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12119319 ↗MalfunctionAug 21, 2019Break; Break
ACCORDING TO THE REPORTER, DURING A TOTAL HIP ARTHROPLASTY, THE THREAD BROKE OFF IMMEDIATELY. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8919104 ↗MalfunctionMay 18, 2018Break; Break
ACCORDING TO THE REPORTER, DURING AN ORTHOPEDIC SURGERY, THE THREAD BROKE IN THE MIDDLE WAY. IT WAS STATED THAT THE CUSTOMER THOUGHT IT MIGHT NEAR OF THE LOOP. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7528003 ↗
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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- 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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