V-Loc 90 VLOCM0604Recalls & reported problems
Covidien LP · Absorbable Wound Closure Device · Class 2 · Implant
All models of V-Loc 90 (56)
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.
Quick summary
This Covidien V-Loc 90 absorbable wound closure suture has 195 reports, 7 injuries and no deaths. Many reports describe the suture thread breaking or the needle detaching during procedures, and some say a replacement was needed mid-surgery. It has 1 open recall, started in June 2026, because the sterile packaging may have a tear or perforation, which could let the sutures become contaminated and lead to infection.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 195
- Deaths reported
- 0
- Injuries reported
- 7
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 195 adverse event reports that list this exact device (DI 10884521132542), received between Nov 3, 2017 and Sep 29, 2026 — classified as 7 injuries, 188 malfunctions.
The most frequently reported specific device problem is “Break” (122 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
- Break122
- Detachment of Device or Device Component73
- Component Missing5
- Detachment Of Device Component3
- Insufficient Device Problem Information3
- Unraveled Material2
- Adverse Event Without Identified Device or Use Problem1
- Difficult or Delayed Positioning1
Patient problems
- No Clinical Signs, Symptoms or Conditions118
- Insufficient Information43
- No Known Impact Or Consequence To Patient15
- No Consequences Or Impact To Patient13
- No Information6
- No Patient Involvement5
- Unintended Radiation Exposure4
- Failure to Anastomose2
Recent adverse event reports
The 25 most recent of 195 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50934369 ↗MalfunctionSep 21, 2026Break
It was reported that preoperatively, the suture broke. An additional new suture was used without issue. There was no patient involved.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50838085 ↗MalfunctionJun 19, 2026Break
ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE LOOP WAS BROKEN. THE ISSUE OCCURRED ON 10 SUTURES FROM THE SAME BATCH. A NEW PRODUCT WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25559796 ↗MalfunctionJun 19, 2026Break
ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE LOOP WAS BROKEN. THE ISSUE OCCURRED ON 10 SUTURES FROM THE SAME BATCH. A NEW PRODUCT WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25559711 ↗MalfunctionJun 15, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A COLON SURGERY, WHILE SUTURING, THE NEEDLE DETACHED FROM THE SUTURE AND FELL INTO THE PATIENT CAVITY.
Patient problems: Insufficient Information
MAUDE report 25505047 ↗MalfunctionJun 9, 2026Difficult to Open or Close
IT WAS REPORTED THAT DURING A PROCEDURE, THE THREAD GETS LOOSENED THE MOMENT IT KNIT THE SUTURE AND PULL IT ON THE LOOP TO LIGATE THE AREA THAT COULD BLEED. AFTER REPLACING WITH A NEW THREAD, THE SURGERY PROCEEDED.
Patient problems: Insufficient Information
MAUDE report 25446574 ↗MalfunctionMay 1, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A PROCEDURE, THE SUTURES DETACHED FROM THE NEEDLE WHILE SUTURING. A THIRD SUTURE FROM THE SAME SET WAS OPENED AND DID NOT HAVE THE ISSUE. IT WAS REPORTED THAT THE PATIENT EXPERIENCED NO CONSEQUENCES OR IMPACT AND WAS ALIVE WITH NO INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25054738 ↗MalfunctionApr 30, 2026Component Missing
ACCORDING TO THE REPORTER, PREOPERATIVELY, THE SUTURE HAD NO NEEDLE PRESENT. THERE WAS NO PATIENT INVOLVED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 25049128 ↗MalfunctionApr 11, 2026Break
IT WAS REPORTED THAT DURING A ROBOTIC HERNIA REPAIR PROCEDURE, THE SUTURE BROKE WHILE SUTURING UPON CLOSURE. THE END OF THE SUTURE WAS CUT AND THE PROCEDURE WAS COMPLETED USING ANOTHER SUTURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24847505 ↗MalfunctionFeb 17, 2026Break
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC UNILATERAL HERNIA REPAIR, DURING PERITONEAL SUTURING, THE SUTURE BROKE. THE PRODUCT WAS IMMEDIATELY REPLACED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24365096 ↗InjuryFeb 10, 2026Unraveled Material
IT WAS REPORTED THAT POSTOPERATIVELY OF A TRANSABDOMINAL PREPERITONEAL (TAPP) SURGERY FOR INGUINAL HERNIA, THE SUTURE LIMB WAS CUT WITH A 3 CM LIMB, AND THAT LIMB MADE A HOLE IN THE BOWEL, RESULTING IN BOWEL PERFORATION. THE PATIENT REQUIRED READMITTANCE TO THE HOSPITAL.
Patient problems: Perforation; Tissue Breakdown
MAUDE report 24305199 ↗MalfunctionJan 30, 2026Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE NEEDLE DETACHED FROM THE SUTURES. THE ISSUE OCCURRED ON 12 SUTURES FROM THE SAME BATCH AND ONE SUTURE FROM A DIFFERENT BATCH. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24222429 ↗MalfunctionJan 29, 2026Break
IT WAS REPORTED THAT DURING A ROBOTIC HERNIA REPAIR PROCEDURE, THE SUTURE BROKE WHILE SUTURING. AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24217377 ↗MalfunctionJan 23, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT INTRAOPERATIVELY, DURING SUTURING OR PREPARING THE SUTURE AFTER PATIENT INCISION, NEEDLE DETACHMENT OCCURRED BUT DID NOT FALL INTO THE PATIENT CAVITY. A NEW SUTURE USED WITHOUT ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24164379 ↗MalfunctionJan 16, 2026Break
IT WAS REPORTED THAT DURING A PROCEDURE, TWENTY DEVICES HAD A BREAKAGE.
Patient problems: Insufficient Information
MAUDE report 24104618 ↗MalfunctionJan 16, 2026Break
IT WAS REPORTED THAT DURING A PROCEDURE, TWENTY DEVICES HAD A BREAKAGE.
Patient problems: Insufficient Information
MAUDE report 24104398 ↗MalfunctionJan 16, 2026Break
IT WAS REPORTED THAT DURING A PROCEDURE, TWENTY DEVICES HAD A BREAKAGE.
Patient problems: Insufficient Information
MAUDE report 24104386 ↗MalfunctionJan 16, 2026Break
IT WAS REPORTED THAT DURING A PROCEDURE, TWENTY DEVICES HAD A BREAKAGE.
Patient problems: Insufficient Information
MAUDE report 24104148 ↗MalfunctionJan 16, 2026Break
IT WAS REPORTED THAT DURING A PROCEDURE, 20 DEVICES HAD BREAKAGE.
Patient problems: Insufficient Information
MAUDE report 24096373 ↗MalfunctionJan 16, 2026Break
IT WAS REPORTED THAT DURING A PROCEDURE, (B)(4) DEVICES HAD BREAKAGE.
Patient problems: Insufficient Information
MAUDE report 24096349 ↗MalfunctionJan 16, 2026Break
IT WAS REPORTED THAT DURING A PROCEDURE, 20 DEVICES HAD BREAKAGE.
Patient problems: Insufficient Information
MAUDE report 24096314 ↗MalfunctionJan 16, 2026Break
IT WAS REPORTED THAT DURING A PROCEDURE, 20 DEVICES HAD BREAKAGE.
Patient problems: Insufficient Information
MAUDE report 24096015 ↗MalfunctionJan 16, 2026Break
IT WAS REPORTED THAT DURING A PROCEDURE, 20 DEVICES HAD BREAKAGE.
Patient problems: Insufficient Information
MAUDE report 24095990 ↗MalfunctionJan 8, 2026Break
IT WAS REPORTED THAT DURING A LAPAROSCOPIC GASTROINTESTINAL TRACT RECONSTRUCTION PROCEDURE INVOLVING THE STOMACH, WHILE CONTINUOUS SUTURING WAS BEING PERFORMED, THE SUTURE BROKE AFTER ONE STITCH. THE ISSUE WAS RESOLVED BY USING ANOTHER SUTURE TO COMPLETE THE CASE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24003485 ↗MalfunctionDec 24, 2025Component Missing; Component Missing
ACCORDING TO THE REPORTER, PREOPERATIVELY, THE NEEDLE IS MISSING FROM THE PACKAGE. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23887860 ↗
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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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