Vascufil 88864705-11VRecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10884521101869), received between Aug 26, 2020 and Aug 7, 2024 — classified as 5 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Break” (11 reports).

2 other recalls cover devices cleared under the same FDA submission (K990952); 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

Recent adverse event reports

The 12 most recent of 12 reports, 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 ↗
• 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 ↗
• 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 ↗
• MalfunctionSep 1, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PREOPERATIVELY, WHEN LOADING, THE NEEDLE SEPARATED FROM THE THREADS. A SUTURE FROM ANOTHER LOT WAS USED TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12407177 ↗
• MalfunctionAug 27, 2020Break; Break

  ACCORDING TO THE REPORTER, WHILE SUTURING DURING PEDIATRIC HEART SURGERY, THE NEEDLE BROKE. ANOTHER SUTURE WAS USED TO COMPLETE THE SURGERY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10458421 ↗
• MalfunctionAug 26, 2020Break; Break

  ACCORDING TO THE REPORTER, DURING A PEDIATRIC OPEN CARDIAC SURGERY, WHILE USING CONTINUOUS SUTURING, THE NEEDLE BROKE. THE SURGEON REMOVED THE SUTURE AND SUTURED AGAIN USING A NEW DEVICE. SURGICAL TIME WAS EXTENDED FOR MORE THAN 30 MINUTES. THERE WAS NO PATIENT INJURY.

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 10453259 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K990952. One submission often covers many models, so check the product and lot details in each record.

• Z-1181-2023 · Dec 2, 2022 · Open, Classified
  Ti-Cron Coated Braided Polyester Suture Product Description 88862775-31 TICRON* 4-0 BLU 75CM CV327DA 88862880-41 TICRON* 3-0 WHI 75CM Y31DA 88863012-61 TICRON* 0 BLU 90CM C16 X36 8
• Z-1175-2023 · Dec 2, 2022 · Open, Classified
  Novafil Monofilament Polybutester Suture Product Description: 8886 4002-41 NOVAFIL 3-0 BLU 90CM C14 8886 4400-13 NOVAFIL 6-0 BLU 45CM SBE2 8886 4400-23 NOVAFIL 5-0 BLU 45CM SBE2 8