VLOC 90 VLOCM0436Recalls & reported problems
Covidien LP · Absorbable Wound Closure Device · Class 2 · Implant
All models of VLOC 90 (4)
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.
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10884521827516), received between Sep 7, 2023 and Jun 25, 2026 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Break” (3 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-2918-2026 · Root cause: Equipment maintenance · Recall details · FDA record ↗
Most reported problems
Device problems
- Break3
- Component Missing1
- Detachment of Device or Device Component1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Insufficient Information1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 25, 2026Break; Component Missing
ACCORDING TO THE REPORTER, DURING A CESAREAN SECTION WHILE SUTURING THE UTERUS, THE SUTURE DID NOT HOLD IN TISSUE DUE TO THE BARBS NOT FIXATING PROPERLY AND THEN THE THREAD BROKE IN THE MIDDLE. A NEW SUTURE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25617775 ↗MalfunctionMar 19, 2026Break
ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, WHILE SUTURING, THE SUTURE SNAPPED. THE ISSUE HAPPENED TO MULTIPLE SUTURES. ANOTHER SUTURE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24646183 ↗MalfunctionNov 6, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A CAESAREAN SECTION PROCEDURE, THE SUTURE THREAD OF THE DEVICE DETACHED FROM THE NEEDLE WHILE SUTURING THE UTERUS. NO COMPONENT FELL INTO THE CAVITY. TO RESOLVE THE ISSUE, A NEW DEVICE WAS USED.
Patient problems: Insufficient Information
MAUDE report 23486790 ↗MalfunctionSep 7, 2023Break; Break
ACCORDING TO THE REPORTER, DURING AN OPEN CESAREAN SECTION PROCEDURE, WHEN THE SURGEON BEGAN TO CLOSE THE UTERUS USING THE ABSORBABLE SUTURE VIA THE RUNNING LOCKING STICH TECHNIQUE, A FEW SECONDS AFTER PASSING THROUGH THE LOOP, THE THREAD SNAPPED ON THE THIRD STITCH. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17704345 ↗
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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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