Surgipro CP-412Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 10884521036123), received between Jul 28, 2017 and Mar 19, 2025 — classified as 2 injuries, 17 malfunctions.

The most frequently reported specific device problem is “Break” (17 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 19, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE SUTURE BROKE WHILE THE HERNIAL SAC WAS BEING SUTURED. THE DOCTOR SUCCESSFULLY TIED THE FIRST KNOT, BUT THE SUTURE BROKE IN THE MIDDLE DURING THE SECOND KNOT WITHOUT ANY APPLIED TRACTION OR FORCE. A NEW SUTURE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21643113 ↗
• MalfunctionFeb 6, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, WHILE SUTURING, THE SUTURE BROKE IN THE MIDDLE. A SECOND SUTURE OF THE SAME REFERENCE AND CALIBER WAS USED BUT IT WAS ALSO BROKE. A THIRD SUTURE FROM ANOTHER MANUFACTURER WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21326653 ↗
• MalfunctionFeb 6, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, WHILE SUTURING, THE SUTURE BROKE IN THE MIDDLE. A SECOND SUTURE OF THE SAME REFERENCE AND CALIBER WAS USED BUT IT WAS ALSO BROKE. A THIRD SUTURE FROM ANOTHER MANUFACTURER WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21326642 ↗
• MalfunctionOct 24, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE SUTURE BROKE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20522689 ↗
• MalfunctionJun 26, 2024Break; Material Twisted/Bent; Break; Material Twisted/Bent

  ACCORDING TO THE REPORTER, IN A LAPAROSCOPIC COLECTOMY PROCEDURE, WHILE CLOSING THE UMBILICAL PORT, WITHOUT EXERTING FORCE, THE NEEDLE BENT WHEN PASSING THROUGH THE TISSUE. THE STRAND OF THE POLYPROPYLENE SUTURE ALSO BROKE. TO RESOLVE THE ISSUE, ANOTHER SUTURE WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19615513 ↗
• MalfunctionJun 5, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING A UMBILICAL HERNIA REPAIR, OPEN PROCEDURE, WHEN KNOTTING THE SUTURE TO CLOSE THE DISSECT, THE TWO THREAD BROKE. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19470432 ↗
• MalfunctionJun 5, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING A UMBILICAL HERNIA REPAIR, OPEN PROCEDURE, WHEN KNOTTING THE SUTURE TO CLOSE THE DISSECT, THE TWO THREAD BROKE. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19470031 ↗
• MalfunctionMar 14, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING EXPLORATORY LAPAROTOMY, THE DEVICE BROKE. THERE WAS NO PATIENT INJURY.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16542353 ↗
• MalfunctionSep 3, 2021Break; Break

  ACCORDING TO THE REPORTER, THE SUTURE BROKE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12425313 ↗
• MalfunctionAug 9, 2021Break; Break

  ACCORDING TO THE REPORTER, DURING ROBOTIC SACROCOLPOPEXY, AFTER NAVIGATING THE RETRO-PERITONEAL FAT, THE ILIAC VESSELS, MIDSACRAL ARTERIES AND VEINS AS WELL AS HYPOGASTRIC PLEXUS, THE SUTURE BROKE AT THE KNOT ON THE ANTERIOR VERTEBRAL LIGAMENT. SURGEON USED ANOTHER RELOAD TO RESOLVE THE ISSUE. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12294083 ↗
• MalfunctionJul 23, 2021Break; Break

  ACCORDING TO THE REPORTER DURING LAPAROSCOPIC GYNECOLOGICAL PROCEDURE, WHILE ON FASCIA CLOSURE THE THREAD BROKE. IN ORDER TO FIX THE ISSUE, A NEW SUTURE FROM OTHER MANUFACTURER WAS USED BY THE SURGEON TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12217524 ↗
• MalfunctionSep 29, 2020Break; Break

  ACCORDING TO THE REPORTER, DURING AN OPEN GENERAL SURGERY, AT THE MOMENT OF CLOSING THE FASCIA WHEN MAKING THE KNOT OF THE SUTURE WITHOUT EXERTING GREATER FORCE, THE THREAD BROKE. THE USER HAD TO PASS THE STITCH AGAIN AND USE A NEW SUTURE TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10598019 ↗
• MalfunctionSep 9, 2020Break; Break

  ACCORDING TO THE REPORTER, DURING AN EPINEURAL SURGERY, THE SUTURE BROKE WHILE TYING. SO THE POINT WAS RELEASED AND THEREFORE HAD TO PASS POINT AGAIN. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10511157 ↗
• InjuryOct 30, 2019Unraveled Material; Unraveled Material

  ACCORDING TO THE REPORTER, FOUR DAYS FOLLOWING AN EPIGASTRIC HERNIA REPAIR, THE PATIENT RETURNED TO THE EMERGENCY ROOM WITH A DISTENDED ABDOMEN AND THERE WAS AN EVIDENCE OF TOTAL DEHISCENCE OF SUTURES AND COMPLETE EVISCERATION. AN INTERVENTION WAS PERFORMED TO PLACE A MESH.

  Patient problems: Abdominal Distention; No Code Available

  MAUDE report 9256707 ↗
• MalfunctionSep 2, 2019Break; Break

  ACCORDING TO THE REPORTER, AT THE TIME OF THE FIXATION AND CLOSURE OF THE KNOTS DURING A HERNIORRHAPHY, THE SUTURE BROKE. A NEW SUTURE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8953533 ↗
• MalfunctionSep 2, 2019Break; Break

  ACCORDING TO THE REPORTER, AT THE TIME OF THE FIXATION AND CLOSURE OF THE KNOTS DURING A LAPAROSCOPIC INGUINAL HERNIORRHAPHY, THE SUTURE BROKE. A NEW SUTURE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8953520 ↗
• MalfunctionAug 15, 2019Break; Break

  ACCORDING TO THE REPORTER, DURING AN UMBILICAL HERNIA REPAIR, WHEN THE SUTURE IS KNOTTED, IT BREAKS. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8899830 ↗
• MalfunctionMar 4, 2019Material Frayed; Material Frayed

  ACCORDING TO THE REPORTER, DURING OPEN INGUINAL HERNIA REPAIR, WHILE CLOSING THE WOUND THE SUTURE FRAYED. THE SURGEON USED THE USUAL TECHNIQUE IN SUTURING. ANOTHER SUTURE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8386422 ↗
• InjuryJul 28, 2017Break; Break

  ACCORDING TO THE REPORTER, DURING AN OPEN ULCER RESECTION PROCEDURE, THE SUTURES KEPT BREAKING. THE INCISION WAS EXTENDED MORE THAN 1 INCH DUE TO THE ISSUE AND MEDICAL OR SURGICAL INTERVENTION WAS NEEDED TO PREVENT PERMANENT IMPAIRMENT OF FUNCTION. THE PATIENT IS ALIVE WITH INJURY.

  Patient problems: Blood Loss; No Code Available

  MAUDE report 6751020 ↗

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