Vascufil 88864756-11VRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10884521102156), received between Jul 15, 2019 and Oct 25, 2022 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• MalfunctionJul 22, 2021Break; Break

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY OF A CAROTID STENOSIS, WHILE THE SURGEON WAS TRYING SEW A CAROTID ARTERY WITH ATHEROSCLEROTIC PLAQUE USING THE CONTINUOUS SUTURING TECHNIQUE, THE NEEDLES OF 7 DEVICES BROKE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THE SURGICAL TIME WAS EXTENDED FOR ABOUT 20 MINUTES. THERE WAS NO PATIENT INJURY.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12215357 ↗
• InjuryJul 19, 2019Break; Unraveled Material; Break; Unraveled Material

  ACCORDING TO THE REPORTER, POST-OPERATIVELY ON AN OPEN CAROTID PROCEDURE, THE SURGEON HAD TO PERFORMED EMERGENCY SURGERY, BECAUSE THE PATCH CAME LOOSE, SO A LIVE THREATENING SITUATION MAY HAPPENED. IT ALSO REPORTED BY THE SURGEON THAT INTRA-OPERATIVELY WHILE USING THE COMPLAINT DEVICE THEY HAVE ALREADY ENCOUNTERED BREAKING EVEN WITHOUT EXCESSIVE FORCE WAS USED. TO RESOLVE THE ISSUE THEY PERFORMED THE SAME OPERATION AGAIN.

  Patient problems: No Code Available

  MAUDE report 8807793 ↗
• MalfunctionJul 15, 2019Break; Break

  ACCORDING TO THE REPORTER, DURING THE OPEN CAROTIS PROCEDURE, WHILE PLACING THE PATCH IN CAROTID ARTERECTOMY, THE SUTURE BROKE WITHOUT PUTTING MUCH TENSION ON IT. THE SURGEON TOOK A NEW PRODUCT AND CONTINUED THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Information

  MAUDE report 8789778 ↗

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