Coated VICRYL VCP214H (UDI 10705031076839)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10705031076839), received between Feb 18, 2026 and Feb 18, 2026 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Material Separation” (5 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, 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 18, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED WHILE SUTURING CATHETERS IN PLACE AND/OR SUTURING PORT INCISIONS ON PATIENTS IN RADIOLOGY, THE NEEDLE HAS BROKEN OFF FROM THE SUTURE. ONE OF THE NEEDLES BROKE OFF UNDERNEATH THE PATIENT'S SKIN BUT GIVEN IT WAS OPEN INCISION, IT WAS ABLE TO BE REMOVED IMMEDIATELY. IT BREAKS OFF RIGHT WHERE THE NEEDLE AND SUTURE COME TOGETHER. THIS HAS HAPPENED WITH 5 DIFFERENT PATIENTS AND WITH DIFFERENT STAFF SUTURING. ANOTHER INCIDENT WAS WHEN THE SUTURE FRAYED AND DID NOT COME APART BUT THIS ALSO HAPPENED AT THE SAME SPOT ON THE PRODUCT. THERE ARE NO INJURIES OR ADVERSE EVENT REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24376709 ↗
• MalfunctionFeb 18, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED WHILE SUTURING CATHETERS IN PLACE AND/OR SUTURING PORT INCISIONS ON PATIENTS IN RADIOLOGY, THE NEEDLE HAS BROKEN OFF FROM THE SUTURE. ONE OF THE NEEDLES BROKE OFF UNDERNEATH THE PATIENT'S SKIN BUT GIVEN IT WAS OPEN INCISION, IT WAS ABLE TO BE REMOVED IMMEDIATELY. IT BREAKS OFF RIGHT WHERE THE NEEDLE AND SUTURE COME TOGETHER. THIS HAS HAPPENED WITH 5 DIFFERENT PATIENTS AND WITH DIFFERENT STAFF SUTURING. ANOTHER INCIDENT WAS WHEN THE SUTURE FRAYED AND DID NOT COME APART BUT THIS ALSO HAPPENED AT THE SAME SPOT ON THE PRODUCT. THERE ARE NO INJURIES OR ADVERSE EVENT REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24376694 ↗
• MalfunctionFeb 18, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED WHILE SUTURING CATHETERS IN PLACE AND/OR SUTURING PORT INCISIONS ON PATIENTS IN RADIOLOGY, THE NEEDLE HAS BROKEN OFF FROM THE SUTURE. ONE OF THE NEEDLES BROKE OFF UNDERNEATH THE PATIENT'S SKIN BUT GIVEN IT WAS OPEN INCISION, IT WAS ABLE TO BE REMOVED IMMEDIATELY. IT BREAKS OFF RIGHT WHERE THE NEEDLE AND SUTURE COME TOGETHER. THIS HAS HAPPENED WITH 5 DIFFERENT PATIENTS AND WITH DIFFERENT STAFF SUTURING. ANOTHER INCIDENT WAS WHEN THE SUTURE FRAYED AND DID NOT COME APART BUT THIS ALSO HAPPENED AT THE SAME SPOT ON THE PRODUCT. THERE ARE NO INJURIES OR ADVERSE EVENT REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24376662 ↗
• MalfunctionFeb 18, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED WHILE SUTURING CATHETERS IN PLACE AND/OR SUTURING PORT INCISIONS ON PATIENTS IN RADIOLOGY, THE NEEDLE HAS BROKEN OFF FROM THE SUTURE. ONE OF THE NEEDLES BROKE OFF UNDERNEATH THE PATIENT'S SKIN BUT GIVEN IT WAS OPEN INCISION, IT WAS ABLE TO BE REMOVED IMMEDIATELY. IT BREAKS OFF RIGHT WHERE THE NEEDLE AND SUTURE COME TOGETHER. THIS HAS HAPPENED WITH 5 DIFFERENT PATIENTS AND WITH DIFFERENT STAFF SUTURING. ANOTHER INCIDENT WAS WHEN THE SUTURE FRAYED AND DID NOT COME APART BUT THIS ALSO HAPPENED AT THE SAME SPOT ON THE PRODUCT. THERE ARE NO INJURIES OR ADVERSE EVENT REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24376594 ↗
• MalfunctionFeb 18, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED WHILE SUTURING CATHETERS IN PLACE AND/OR SUTURING PORT INCISIONS ON PATIENTS IN RADIOLOGY, THE NEEDLE HAS BROKEN OFF FROM THE SUTURE. ONE OF THE NEEDLES BROKE OFF UNDERNEATH THE PATIENT'S SKIN BUT GIVEN IT WAS OPEN INCISION, IT WAS ABLE TO BE REMOVED IMMEDIATELY. IT BREAKS OFF RIGHT WHERE THE NEEDLE AND SUTURE COME TOGETHER. THIS HAS HAPPENED WITH 5 DIFFERENT PATIENTS AND WITH DIFFERENT STAFF SUTURING. ANOTHER INCIDENT WAS WHEN THE SUTURE FRAYED AND DID NOT COME APART BUT THIS ALSO HAPPENED AT THE SAME SPOT ON THE PRODUCT. THERE ARE NO INJURIES OR ADVERSE EVENT REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24376446 ↗
• MalfunctionFeb 18, 2026Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED WHILE SUTURING CATHETERS IN PLACE AND/OR SUTURING PORT INCISIONS ON PATIENTS IN RADIOLOGY, THE NEEDLE HAS BROKEN OFF FROM THE SUTURE. ONE OF THE NEEDLES BROKE OFF UNDERNEATH THE PATIENT'S SKIN BUT GIVEN IT WAS OPEN INCISION, IT WAS ABLE TO BE REMOVED IMMEDIATELY. IT BREAKS OFF RIGHT WHERE THE NEEDLE AND SUTURE COME TOGETHER. THIS HAS HAPPENED WITH 5 DIFFERENT PATIENTS AND WITH DIFFERENT STAFF SUTURING. ANOTHER INCIDENT WAS WHEN THE SUTURE FRAYED AND DID NOT COME APART BUT THIS ALSO HAPPENED AT THE SAME SPOT ON THE PRODUCT. THERE ARE NO INJURIES OR ADVERSE EVENT REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24376391 ↗
• MalfunctionFeb 18, 2026Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED WHILE SUTURING CATHETERS IN PLACE AND/OR SUTURING PORT INCISIONS ON PATIENTS IN RADIOLOGY, THE NEEDLE HAS BROKEN OFF FROM THE SUTURE. ONE OF THE NEEDLES BROKE OFF UNDERNEATH THE PATIENT'S SKIN BUT GIVEN IT WAS OPEN INCISION, IT WAS ABLE TO BE REMOVED IMMEDIATELY. IT BREAKS OFF RIGHT WHERE THE NEEDLE AND SUTURE COME TOGETHER. THIS HAS HAPPENED WITH 5 DIFFERENT PATIENTS AND WITH DIFFERENT STAFF SUTURING. ANOTHER INCIDENT WAS WHEN THE SUTURE FRAYED AND DID NOT COME APART BUT THIS ALSO HAPPENED AT THE SAME SPOT ON THE PRODUCT. THERE ARE NO INJURIES OR ADVERSE EVENT REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24376387 ↗
• MalfunctionFeb 18, 2026Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED WHILE SUTURING CATHETERS IN PLACE AND/OR SUTURING PORT INCISIONS ON PATIENTS IN RADIOLOGY, THE NEEDLE HAS BROKEN OFF FROM THE SUTURE. ONE OF THE NEEDLES BROKE OFF UNDERNEATH THE PATIENT'S SKIN BUT GIVEN IT WAS OPEN INCISION, IT WAS ABLE TO BE REMOVED IMMEDIATELY. IT BREAKS OFF RIGHT WHERE THE NEEDLE AND SUTURE COME TOGETHER. THIS HAS HAPPENED WITH 5 DIFFERENT PATIENTS AND WITH DIFFERENT STAFF SUTURING. ANOTHER INCIDENT WAS WHEN THE SUTURE FRAYED AND DID NOT COME APART BUT THIS ALSO HAPPENED AT THE SAME SPOT ON THE PRODUCT. THERE ARE NO INJURIES OR ADVERSE EVENT REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24376364 ↗