V-LocRecalls & reported problems across all models
Covidien LP · 18 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one V-Loc model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 296
- Deaths reported
- 0
- Injuries reported
- 31
- Recalls
- 1
We found 18 models of V-Loc by Covidien LP in the FDA's device registry (GUDID). Together they are named in 296 adverse event reports in the FDA's MAUDE database, received between May 6, 2016 and Sep 17, 2026 — classified as 31 injuries, 265 malfunctions.
The most frequently reported specific device problem is “Break” (216 reports).
1 FDA recall record name at least one of these models by its device 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
V-Loc recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Sep 28, 2022Open, Classified
Medtronic has received 210 reports of needles breaking during endoscopic suturing. The potential harm(s) include a delay in treatment/therapy, the potential for a portion of the needle to remain in the patient, foreign body reaction, allergic reaction, tissue injury and unintended radiation exposure from additional imaging for both intra-op and postoperative scenarios.
Z-0201-2023 · Root cause: Process control · names 9 of these models · Recall details · FDA record ↗
Most reported V-Loc problems
Device problems
- Break216
- Detachment of Device or Device Component81
- Adverse Event Without Identified Device or Use Problem12
- Unraveled Material7
- Detachment Of Device Component4
- Insufficient Device Problem Information4
- Material Frayed3
- Patient-Device Incompatibility3
Patient problems
- No Clinical Signs, Symptoms or Conditions153
- No Known Impact Or Consequence To Patient69
- Insufficient Information30
- No Consequences Or Impact To Patient21
- No Code Available10
- Foreign Body In Patient7
- Unintended Radiation Exposure7
- Radiation Exposure, Unintended4
V-Loc models
18 models, most reported first. Each model has its own page with its reports, recalls and device details.
- V-Loc VLOCN0604SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE112 reports
- V-Loc VLOCN206LSUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE1 recall18 reports
- V-Loc VLOCN006LSUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE1 recall8 reports
- V-Loc VLOCN008LSUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE1 recall5 reports
- V-Loc VLOCN208LSUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE1 recall4 reports
- V-Loc VLOCN308LSUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE1 recall1 report
- V-Loc VLOCN004LSUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE1 recall0 reports
- V-Loc VLOCN204LSUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE1 recall0 reports
- V-Loc VLOCN304LSUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE1 recall0 reports
- V-Loc VLOCN306LSUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE1 recall0 reports
- V-Loc VLOCN0326SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE32 reports
- V-Loc VLOCN0327SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE27 reports
- V-Loc VLOCN0605SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE25 reports
- V-Loc VLOCN0644SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE24 reports
- V-Loc VLOCN0615SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE20 reports
- V-Loc VLOCN0306SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE9 reports
- V-Loc VLOCN1126SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE9 reports
- V-Loc VLOCN0804SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE2 reports
Recent V-Loc adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 17, 2026Break
It was reported that during a laparoscopic inguinal hernia repair procedure, the needle broke. There was no patient injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50804558 ↗MalfunctionAug 10, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50192670 ↗MalfunctionJul 9, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25770444 ↗MalfunctionJul 9, 2026Break
IT WAS REPORTED THAT DURING A LAPAROSCOPIC REPAIR OF A VENTRAL HERNIA, WHILE THE PERITONEUM WAS BEING SUTURED, THE SUTURE THREAD SNAPPED CLOSE TO THE NEEDLE, BUT NOT AT THE NEEDLE-TO-SUTURE JOINT. THE NEEDLE THEN FELL INTO THE ABDOMEN, THOUGH IT WAS RETRIEVED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25763600 ↗MalfunctionMay 4, 2026Break
IT WAS REPORTED THAT DURING A LAPAROSCOPIC UMBILICAL HERNIA PROCEDURE, WHILE SUTURING, AFTER PASSAGE OF THE NEEDLE THROUGH THE LOOP AND FIXING IT AT THE START POINT, THE LOOP BROKE. THE SUTURE WAS REMOVED AND A COMPETITOR BARBED SUTURE WAS USED TO CONTINUE. THEREWAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25072274 ↗MalfunctionApr 13, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A BARIATRIC SADI (SINGLE ANASTOMOSIS DUODENO-ILEAL BYPASS WITH SLEEVE GASTRECTOMY) LAPAROSCOPIC PROCEDURE, WHILE CLOSING A HIATAL HERNIA, THE SUTURE DETACHED FROM THE METAL CRIMP AT THE TRANSITION PIECE FROM THE SILK TO HANDLE ON THE RELOAD DURING NORMAL SUTURING MOTION. THERE WAS NO TENSION APPLIED AT THE TIME OF DETACHMENT, AND THE SUTURE SIMPLY FELL OUT. ANOTHER SUTURE WAS OPENED TO RESOLVE THE ISSUE AND 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 24853757 ↗MalfunctionApr 1, 2026Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE NEEDLE BECAME DISLODGED FROM THE SUTURE MATERIAL DURING COLON ANASTOMOSIS UPON NEEDLE WITHDRAWAL. THE SAME ISSUE OCCURRED ON THE SECOND SUTURE.
Patient problems: Insufficient Information
MAUDE report 24753124 ↗MalfunctionMar 30, 2026Break
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC INCISIONAL HERNIA REPAIR, ON THE ABDOMINAL WALL, THE SUTURE BROKE IN THE MIDDLE. ANOTHER NEW SUTURE WAS USED WITHOUT ANY PROBLEMS. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24722674 ↗MalfunctionMar 19, 2026Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A ROBOTIC GASTRIC BYPASS, WHILE ON COLON ANASTOMOSIS UPON NEEDLE WITHDRAWAL, THE NEEDLE BECAME DISLODGED FROM THE SUTURE MATERIAL. THE SAME ISSUE OCCURRED ON THE SECOND SUTURE. A NEW SUTURE FROM A DIFFERENT BATCH WAS USED TO RESOLVE THE ISSUE. THE SURGICAL TIME WAS PROLONGED. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24637607 ↗MalfunctionMar 12, 2026Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE NEEDLE BECAME DISLODGED FROM THE SUTURE MATERIAL DURING COLON ANASTOMOSIS UPON NEEDLE WITHDRAWAL. THE SAME ISSUE OCCURRED ON THE SECOND SUTURE.
Patient problems: Insufficient Information
MAUDE report 24584951 ↗MalfunctionMar 4, 2026Break
IT WAS REPORTED THAT DURING A PROCEDURE, THE STRAND OF THE THREE SUTURES BROKE WHEN PULLING THE TISSUE. A NEW SUTURE FROM ANOTHER BRAND WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24510486 ↗MalfunctionMar 4, 2026Break
IT WAS REPORTED THAT DURING A PROCEDURE, THE STRAND OF THE THREE SUTURES BROKE WHEN PULLING THE TISSUE. A NEW SUTURE FROM ANOTHER BRAND WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24510417 ↗MalfunctionMar 4, 2026Break
IT WAS REPORTED THAT DURING A PROCEDURE, THE STRAND OF THE THREE SUTURES BROKE WHEN PULLING THE TISSUE. A NEW SUTURE FROM ANOTHER BRAND WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24504155 ↗MalfunctionMar 3, 2026Break
ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE SUTURE BROKE AND THE NEEDLE WAS FRACTURED.
Patient problems: Insufficient Information
MAUDE report 24497040 ↗MalfunctionMar 2, 2026Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A ROBOTIC GASTRIC BYPASS, THE NEEDLE BECAME DISLODGED FROM THE SUTURE MATERIAL DURING COLON ANASTOMOSIS UPON NEEDLE WITHDRAWAL. THE SAME ISSUE OCCURRED ON THE SECOND SUTURE. A NEW SUTURE FROM A DIFFERENT BATCH WAS USED TO RESOLVE THE ISSUE. THE SURGICAL TIME WAS PROLONGED. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24478649 ↗
Other Covidien LP products
- Endo GIA48 models · 26,277 reports · 8 recalls
- Endo GIA Ultra3 models · 15,650 reports
- Shiley387 models · 9,392 reports · 5 recalls
- Signia16 models · 8,201 reports · 6 recalls
- LigaSure32 models · 7,283 reports · 1 recall
- Tri-Staple 2.037 models · 4,892 reports · 2 recalls
- Polysorb291 models · 4,564 reports · 2 recalls
- EEA39 models · 4,432 reports · 1 recall
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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