VascufilRecalls & reported problems across all models
Covidien LP · 8 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 32
- Deaths reported
- 0
- Injuries reported
- 8
- Recalls
- 0
We found 8 models of Vascufil by Covidien LP in the FDA's device registry (GUDID). Together they are named in 32 adverse event reports in the FDA's MAUDE database, received between Aug 23, 2017 and Aug 7, 2024 — classified as 8 injuries, 24 malfunctions.
The most frequently reported specific device problem is “Break” (27 reports).
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
Most reported Vascufil problems
Device problems
- Break27
- Detachment of Device or Device Component10
- Insufficient Device Problem Information1
- Unraveled Material1
Patient problems
- No Clinical Signs, Symptoms or Conditions18
- Unintended Radiation Exposure5
- Foreign Body In Patient4
- No Consequences Or Impact To Patient3
- Hemorrhage/Blood Loss/Bleeding2
- Insufficient Information2
- No Code Available2
- No Known Impact Or Consequence To Patient2
Vascufil models
8 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Vascufil 88864705-11VSUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE12 reports
- Vascufil 88864704-11VSUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE5 reports
- Vascufil 88864750-31VSUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE5 reports
- Vascufil 88864756-11VSUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE5 reports
- Vascufil 88864710-11VSUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE2 reports
- Vascufil 88864705-01VSUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE1 report
- Vascufil 88864719-21VSUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE1 report
- Vascufil 88864731-51VSUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE1 report
Recent Vascufil adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionAug 7, 2024Break; Break
ACCORDING TO THE REPORTER, PRIOR TO USE, THE THREE NEEDLES WERE BROKEN WHEN THE SUTURE WAS OPENED BEFORE SURGERY. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19932703 ↗MalfunctionAug 7, 2024Break; Break
ACCORDING TO THE REPORTER, PRIOR TO USE, THE THREE NEEDLES WERE BROKEN WHEN THE SUTURE WAS OPENED BEFORE SURGERY. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19932496 ↗MalfunctionAug 7, 2024Break; Break
ACCORDING TO THE REPORTER, PRIOR TO USE, THE THREE NEEDLES WERE BROKEN WHEN THE SUTURE WAS OPENED BEFORE SURGERY. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19932424 ↗InjuryAug 23, 2023Break; Break
ACCORDING TO THE REPORTER, TWO HOURS POSTOPERATIVELY OF AN OPEN HEART SURGERY, THE SURGEON USED A 6-0 NON ABSORBABLE SUTURE AND SUTURED THE LONGITUDINAL OF THE CORONARY VEIN CONTINUOUSLY. THE PATIENT FOUND BLEEDING AFTER RETURNING TO THE WARD AND FOUND THAT THE SUTURE WAS BROKEN. THE SURGEON HAD TO PERFORM A SECOND SURGERY. THE PATIENT RE-ENTERED THE OPERATING ROOM, UNDERWENT A SECOND THORACOTOMY, CHECKED THE BLEEDING SITE AND RE-SUTURED THE BLEEDING.
Patient problems: Hemorrhage/Blood Loss/Bleeding; Tissue Breakdown
MAUDE report 17605411 ↗MalfunctionMar 31, 2023Break; Break
ACCORDING TO THE REPORTER, DURING AN OPEN KIDNEY TRANSPLANT, WHEN THE SUTURE WAS APPLIED TO BLOOD VESSELS, THE NEEDLE BROKE IN THE MIDDLE NEAR THE END OF THE SUTURING. THE BROKEN NEEDLE WAS REMOVED IN THE OPERATING TABLE. ANOTHER SUTURE WAS RE-OPENED, HOWEVER THE NEEDLE AGAIN BROKE IN THE MIDDLE WHILE THE HEALTHCARE PROFESSIONAL WAS PUTTING ON THE NEEDLE HOLDER. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16659355 ↗MalfunctionOct 25, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING AN OPEN PROCEDURE, THE SURGEON WANTED TO SEW THE CAROTID, BUT THE NEEDLES AND THREADS BROKE. THE DEVICE WAS REPLACED TO COMPLETE THE CASE AND RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15668039 ↗MalfunctionOct 24, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING AN OPEN PROCEDURE, THE SURGEON WANTED TO SEW THE CAROTID, BUT THE NEEDLES AND THREADS BROKE. THE DEVICE WAS REPLACED TO COMPLETE THE CASE AND RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15662428 ↗InjuryJun 1, 2022Break; Break
ACCORDING TO THE REPORTER, DURING ATRIAL SEPTAL DEFECT REPAIR, WHEN SUTURING THE RIGHT ATRIUM, THE NEEDLE BROKE AT THE THIRD STITCH. WHEN THE OTHER SIDE OF NEEDLE WAS CLAMPED AND READY TO USE, THE NEEDLE TIP WAS ALSO FOUND BROKEN. AN X-RAY WAS PERFORMED TO MAKE SURE ALL PIECES WERE ACCOUNTED FOR.
Patient problems: Foreign Body In Patient; Unintended Radiation Exposure
MAUDE report 14566205 ↗MalfunctionApr 7, 2022Break; Break
ACCORDING TO THE REPORTER, DURING AN OPEN CAROTID RECONSTRUCTION, THE NEEDLE OF THE DEVICE BROKE. TO RESOLVE THE ISSUE, A NEW DEVICE WAS USED. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14048722 ↗MalfunctionMar 29, 2022Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A PROCEDURE, WHEN SEWING IN BOVINE PATCHES OR VASCULAR SEAMS, THE NEEDLE BROKE INTO PIECES AND FELL ON THE PATIENT'S CAVITY. THE SURGEON WAS ABLE TO RETRIEVE THE NEEDLE PIECES AND THERE WAS NO RESIDUES OF THE NEEDLE ON THE PATIENT DUE TO THE ISSUE. TO RESOLVE THE ISSUE, A NEW DEVICE WAS USED. IT WAS NOTED THAT THE SURGERY GOT EXTENDED BUT NOT MORE THAN 30 MINUTES. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13941382 ↗MalfunctionMar 29, 2022Break; Break
ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE NEEDLE BROKE OFF WHEN SEWING IN BOVINE PATCHES OR VASCULAR SEAMS. THE BROKEN NEEDLE FELL INTO THE PATIENT'S BODY AND WAS ABLE TO RETRIEVED. TO RESOLVE THE ISSUE, A NEW DEVICE WAS USED. IT WAS NOTED THAT THE SURGICAL TIME GOT EXTENDED BUT NOT MORE THAN 30 MINUTES. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13935036 ↗MalfunctionMar 28, 2022Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A SURGERY, THE NEEDLE BROKE INTO PIECES AND FELL ON THE PATIENT'S CAVITY. THE SURGEON WAS ABLE TO RETRIEVE THE NEEDLE PIECES AND THERE WERE NO RESIDUES OF THE NEEDLE ON THE PATIENT DUE TO THE ISSUE. A NEW SUTURE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS A DELAY IN THE SURGICAL TIME DUE TO DEVICE PERFORMANCE BUT NOT MORE THAN 30 MINUTES. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13934124 ↗InjuryMar 11, 2022Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A TOTAL ANOMALOUS PULMONARY VENOUS RETURN PROCEDURE, AFTER 10 STITCHES WERE SUTURED, THE NEEDLE WAS CLAMPED AND PASSED THROUGH BY A SMALL BEND. IT WAS FOUND THAT THE NEEDLE TIP WAS BROKEN AND MISSING 1MM. IT WAS IMMEDIATELY SEARCHED BUT NOT FOUND. ARM RADIOGRAPHY WAS DONE, BUT THE MISSING PIECE WAS NOT FOUND AND THE SURGEON DECIDED TO CLOSE THE CHEST AND SENT THE PATIENT TO THE ICU. IT WAS CONFIRMED THAT THE FRAGMENT WAS LEFT INSIDE THE PATIENT'S CAVITY.
Patient problems: Unintended Radiation Exposure
MAUDE report 13732060 ↗InjuryFeb 8, 2022Break; Detachment of Device or Device Component; Insufficient Device Problem Information; Break; Detachment of Device or Device Component; Insufficient Device Problem Information
ACCORDING TO THE REPORTER, DURING AN OPEN HEART PROCEDURE, WHILE AT THE BLOOD VESSEL, THE NEEDLE WAS BROKEN, AND A COMPONENT OF THE DEVICE DISENGAGED INTO PATIENT CAVITY. AN X-RAY FILMING WAS DONE TO LOCATE THE PIECE AND RESOLVE THE ISSUE.
Patient problems: Foreign Body In Patient; Insufficient Information; Unintended Radiation Exposure
MAUDE report 13482470 ↗InjuryFeb 8, 2022Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING AN OPEN HEART PROCEDURE, WHILE AT THE BLOOD VESSEL, THE NEEDLE WAS BROKEN, AND A COMPONENT OF THE DEVICE DISENGAGED INTO PATIENT CAVITY. AN X-RAY FILMING WAS DONE TO LOCATE THE PIECE AND RESOLVE THE ISSUE.
Patient problems: Foreign Body In Patient; Unintended Radiation Exposure
MAUDE report 13482331 ↗
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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