VLOC 90 VLOCM0325Recalls & 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
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10884521140004), received between Aug 4, 2022 and Aug 4, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (1 report).
1 other recall cover devices cleared under the same FDA submission (K100257); 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
- Break1
- Product Quality Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 4, 2022Break; Product Quality Problem; Break; Product Quality Problem
ACCORDING TO THE REPORTER, WITHIN 30 MINUTES AFTER OPENING THE PACKAGE DURING A PROCEDURE, WHEN THE NURSE ATTEMPTED TO USE THE PRODUCT, IT WAS OBSERVED THAT THE DEVICE DID NOT NOT HAVE A LOOP. THE THREAD ALSO BROKE FROM WHERE THE BARB WAS LOCATED. A NEW PRODUCT WAS USED TO RESOLVE THE ISSUE. THE DEFECTIVE PRODUCT WAS NOT USED WITH THE PATIENT AND THE PATIENT WAS FINE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15164697 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K100257. One submission often covers many models, so check the product and lot details in each record.
- Z-2918-2026 · Jun 24, 2026 · Open, ClassifiedV-Loc 90 Absorbable Wound Closure Device VLOC 90 0 VL 22 GS-21 VLOCM0336 VLOC 90 0 VL 22 GS-25 VLOCM0436 VLOCM0436 VLOCM0003 V-LOC* 90 4-0 CLR 15CM P12X12 VLOCM0003 VL
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- 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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