Surgipro VP-945Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10884521039704), received between May 13, 2021 and Jan 28, 2026 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Break” (4 reports).

1 other recall cover devices cleared under the same FDA submission (K954808); 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 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 28, 2026Break

  IT WAS REPORTED THAT DURING A HERNIA REPAIR, WHILE SUTURING MESH TO LIGAMENT TISSUE, THE SUTURE BROKE IN THE MIDDLE. THE SURGEON REPLACED THE STRAND WITH A NEW SUTURE, WHICH WAS USED WITHOUT ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24203201 ↗
• MalfunctionNov 10, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC LOW ANTERIOR RESECTION PROCEDURE, WHILE TYING THE PURSE-STRING SUTURES, THE THREAD BROKE OF THE TWO SUTURES AFTER AN HOUR AND A HALF OF THE PROCEDURE. ANOTHER PRODUCT WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18113638 ↗
• MalfunctionNov 10, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC LOW ANTERIOR RESECTION PROCEDURE, WHILE TYING THE PURSE-STRING SUTURES, THE THREAD BROKE OF THE TWO SUTURES AFTER AN HOUR AND A HALF OF THE PROCEDURE. ANOTHER PRODUCT WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18112829 ↗
• InjuryMay 13, 2021Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING OPEN INGUINAL HERNIA REPAIR, WHEN SUTURING THE MESH, THE TEAM HAD TO X-RAY PATIENT IN THE OPERATING THEATER AS THE NEEDLE TIP BROKE OFF AND FELL INTO THE CAVITY. THE X-RAY DIDN'T SHOW IN THE PATIENT BUT TIP WAS NOT FOUND. A NEW SUTURE FROM A DIFFERENT BRAND WAS USED TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. SURGICAL TIME WAS EXTENDED BY 45 MINUTES AS A RESULT OF THE EVENT.

  Patient problems: Device Embedded In Tissue or Plaque; Unintended Radiation Exposure

  MAUDE report 11816453 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K954808. One submission often covers many models, so check the product and lot details in each record.

• Z-1179-2023 · Dec 2, 2022 · Open, Classified
  Surgipro Monofilament Polypropylene Sutures Product Description CP-535 SURGIPRO* 1 BLU 100CM GS24 X36 CP-824 SURGIPRO* 1 BLU 150CM GS26 X24 CP-825 SURGIPRO* 2 BLU 150CM GS26 X24 VP