V-Loc 90 VLOCM0804Recalls & 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
Quick summary
This Covidien V-Loc 90 is an absorbable surgical suture used to close wounds. Its 104 reports, 13 of them injuries, often describe needles separating from the thread and the suture breaking during sewing, and some describe needles falling into the abdomen and being retrieved. There were no deaths, and no recalls name this device. Reports fell to 11 in the last 12 months from 21 in the previous 12 months.
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
- 104
- Deaths reported
- 0
- Injuries reported
- 13
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 104 adverse event reports that list this exact device (DI 10884521132689), received between Nov 2, 2017 and Jun 16, 2026 — classified as 13 injuries, 91 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (66 reports).
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.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component66
- Break40
- Component Missing3
- Adverse Event Without Identified Device or Use Problem2
- Difficult to Remove2
- Unraveled Material2
- Use of Device Problem2
- Detachment Of Device Component1
Patient problems
- No Clinical Signs, Symptoms or Conditions56
- No Consequences Or Impact To Patient14
- Insufficient Information13
- No Known Impact Or Consequence To Patient8
- Foreign Body In Patient7
- Unintended Radiation Exposure5
- No Code Available3
- No Patient Involvement3
Recent adverse event reports
The 25 most recent of 104 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 16, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A PROCEDURE, THE TWO NEEDLES SEPARATED FROM THE SUTURE THREAD AND FELL INTO THE INTRA-ABDOMINAL SPACE. IT WAS REPORTED THAT THE SURGEON SURGICALLY RETRIEVED AND RECOVERED BOTH NEEDLES. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25519886 ↗MalfunctionJun 16, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A PROCEDURE, THE TWO NEEDLES SEPARATED FROM THE SUTURE THREAD AND FELL INTO THE INTRA-ABDOMINAL SPACE. IT WAS REPORTED THAT THE SURGEON SURGICALLY RETRIEVED AND RECOVERED BOTH NEEDLES. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25519822 ↗MalfunctionJun 1, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A PROSTATECTOMY PROCEDURE, WHILE SUTURING, THE DEVICE BROKE AT THE CONNECTION OF THE NEEDLE AND THREAD. THIS ISSUE OCCURRED ON TWO DEVICES. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25350825 ↗MalfunctionMay 31, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A PROSTATECTOMY PROCEDURE, WHILE SUTURING, THE DEVICE BROKE AT THE CONNECTION OF THE NEEDLE AND THREAD. THIS ISSUE OCCURRED ON TWO DEVICES. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25344853 ↗MalfunctionMar 3, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, THE NEEDLE DETACHED FROM THE SUTURE WHILE SUTURING. THE NEEDLE FELL OFF IN THE PATIENT CAVITY AND WAS RETRIEVED WHEN A GENERAL SURGEON WAS CALLED. THE PROCEDURE WAS EXTENDED BY 15 MINUTES AS A RESULT. AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE.
Patient problems: Insufficient Information
MAUDE report 24499814 ↗MalfunctionDec 19, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, TWO SUTURES WERE COMPLETELY PULLED OFF THE NEEDLE. THE NEEDLE AND SUTURE WERE ABLE TO BE RETRIEVED FROM THE PATIENT.
Patient problems: Insufficient Information
MAUDE report 23858077 ↗MalfunctionDec 19, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, TWO SUTURES WERE COMPLETELY PULLED OFF THE NEEDLE. THE NEEDLE AND SUTURE WERE ABLE TO BE RETRIEVED FROM THE PATIENT.
Patient problems: Insufficient Information
MAUDE report 23858058 ↗MalfunctionDec 12, 2025Break; Break
ACCORDING TO THE REPORTER, DURING A ROBOT-ASSISTED RADICAL PROSTATECTOMY (RARP), IN ROCCO STITCHING, THE SUTURE WAS DAMAGED IN THE CENTER. TO RESOLVE THE ISSUE, A NEW DEVICE WAS USED. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23796737 ↗MalfunctionDec 12, 2025Break; Break
ACCORDING TO THE REPORTER, DURING A ROBOT-ASSISTED RADICAL PROSTATECTOMY (RARP), IN ROCCO STITCHING, THE SUTURE WAS DAMAGED IN THE CENTER. TO RESOLVE THE ISSUE, A NEW DEVICE WAS USED. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23796707 ↗MalfunctionDec 5, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE THREAD DETACHED FROM THE NEEDLE INSIDE THE PATIENT'S ABDOMEN WHILE THE SURGEON WAS MAKING A STITCH IN THE TISSUES. THE THREAD CAME LOOSE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23735451 ↗InjuryNov 13, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING THE ROBOTIC LAPAROSCOPIC PROCTECTOMY, THE RESIDENT PULLED THE SUTURE TOO QUICKLY OUT OF THE TROCAR CAUSING THE NEEDLE TO BREAK OFF FROM THE STRAND. THE NEEDLE FELL INTO THE PATIENT CAVITY, AND THERE WAS DIFFICULTY LOCATING DUE TO ITS SMALL SIZE. AN X-RAY WAS PERFORMED TO HELP LOCATE THE LOST NEEDLE, AND THE SURGICAL TEAM, INCLUDING THE SURGEON AND REGISTERED NURSES, SEARCHED THE TROCARS, FLOOR, AND PATIENT CAVITY. THE NEEDLE WAS SUCCESSFULLY RETRIEVED, AND THE SUTURING WAS COMPLETED WITHOUT THE NEED FOR AN ADDITIONAL SUTURE. THE PROCEDURE WAS EXTENDED BY ROUGHLY 20 MINUTES AS A RESULT.
Patient problems: Unintended Radiation Exposure
MAUDE report 23547838 ↗MalfunctionOct 17, 2025Component Missing; Component Missing
ACCORDING TO THE REPORTER, DURING A PROCEDURE, WHEN THE PACKET WAS OPENED, THERE WAS NO NEEDLE INSIDE. ANOTHER PACKET WAS OPENED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23327478 ↗MalfunctionOct 15, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, THE THREAD BREAKS AT THE NEEDLE CONNECTION.
Patient problems: Insufficient Information
MAUDE report 23297255 ↗MalfunctionOct 15, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, THE THREAD BREAKS AT THE NEEDLE CONNECTION.
Patient problems: Insufficient Information
MAUDE report 23287049 ↗InjurySep 15, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A PROCEDURE, THE NEEDLE DETACHED FROM THE SUTURE WHILE SUTURING AND THE NEEDLE SUBSEQUENTLY FELL INTO THE PATIENT'S CAVITY AND WAS NOT RETRIEVED. IMAGING WAS REQUIRED TO LOCATE THE NEEDLE. AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE.
Patient problems: Foreign Body In Patient; Unintended Radiation Exposure
MAUDE report 23058944 ↗MalfunctionSep 12, 2025Break; Break
ACCORDING TO THE REPORTER, DURING A ROBOTIC-ASSISTED RADICAL PROSTATECTOMY (RARP), DURING BLADDER-URETHRAL ANASTOMOSIS, THE THREAD B ROKE AT THE CENTER ON FOUR SUTURES. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23044409 ↗MalfunctionSep 12, 2025Break; Break
ACCORDING TO THE REPORTER, DURING A ROBOTIC-ASSISTED RADICAL PROSTATECTOMY (RARP), DURING BLADDER-URETHRAL ANASTOMOSIS, THE THREAD BROKE AT THE CENTER ON FOUR SUTURES. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23044398 ↗MalfunctionSep 12, 2025Break; Break
ACCORDING TO THE REPORTER, DURING A ROBOTIC-ASSISTED RADICAL PROSTATECTOMY (RARP), DURING BLADDER-URETHRAL ANASTOMOSIS, THE THREAD BROKE AT THE CENTER ON FOUR SUTURES. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23044379 ↗MalfunctionSep 12, 2025Break; Break
ACCORDING TO THE REPORTER, DURING A ROBOTIC-ASSISTED RADICAL PROSTATECTOMY (RARP), DURING BLADDER-URETHRAL ANASTOMOSIS, THE THREAD B ROKE AT THE CENTER ON FOUR SUTURES. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23044369 ↗MalfunctionJul 3, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A PROCEDURE, A NEEDLE DETACHMENT OCCURRED ON THE TWELVE DEVICES. 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 22401281 ↗MalfunctionJun 12, 2025Break; Break
ACCORDING TO THE REPORTER, DURING PROSTATECTOMY, WHEN THE SUTURE WAS TAKEN OUT FROM THE PACKET, THE LOOP WAS DAMAGED. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 22196399 ↗MalfunctionMay 28, 2025Break; Break
ACCORDING TO THE REPORTER, DURING A PROCEDURE, ONE SUTURE HAD A PROBLEM WHERE THE THREAD CAME OFF THE NEEDLE DURING SUTURING. ANOTHER SUTURE HAD AN INCIDENT WHERE THE SUTURE BROKE BEFORE SUTURING. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE.
Patient problems: Insufficient Information
MAUDE report 22094244 ↗MalfunctionMay 28, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A PROCEDURE, ONE SUTURE HAD A PROBLEM WHERE THE THREAD CAME OFF THE NEEDLE DURING SUTURING. ANOTHER SUTURE HAD AN INCIDENT WHERE THE SUTURE BROKE BEFORE SUTURING. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE.
Patient problems: Insufficient Information
MAUDE report 22094231 ↗MalfunctionMay 13, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER DURING A TRANSABDOMINAL PRE-PERITONEAL INGUINAL HERNIA PROCEDURE, THE THREAD BROKE FROM THE NEEDLE WITHOUT ANY APPLICATION OF FORCE. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22012041 ↗MalfunctionMay 13, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A HERNIA PROCEDURE, DURING CLOSING OF THE PERITONEUM, TOWARDS THE END OF THE SUTURING, THE NEEDLE BECAME DETACHED FROM THE THREAD. A HEMLOCK WAS USED TO CLOSE THE REMAINING PART. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22011269 ↗
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
Other SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID devices
- Coated VICRYL VCP433HEthicon, LLC · SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID1 death1,093 reports
- 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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