Surgipro CP-424Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10884521036222), received between Aug 14, 2017 and Jul 26, 2024 — classified as 1 death, 4 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Break” (15 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 18, 2026.

Most reported problems

Recent adverse event reports

The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 26, 2024Break; Material Twisted/Bent; Break; Material Twisted/Bent

  ACCORDING TO THE REPORTER, DURING A UMBILICAL HERNIA REPAIR PROCEDURE, AFTER THREE PASSES WERE MADE, THE NEEDLE BENT AND WHEN PASSING THE NEXT STITCH, THE THREAD BROKE. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19843079 ↗
• MalfunctionJul 18, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, WHILE CLOSING THE FASCIA, THE THREAD WAS STILL ATTACHED TO THE NEEDLE, BUT THE THREAD BROKE IN THE MIDDLE ALONG ITS LENGTH. THE SAME ISSUE OCCURRED WITH THE SECOND SUTURE. A THIRD SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19778501 ↗
• MalfunctionMay 5, 2023Break; Material Frayed; Device Slipped; Break; Material Frayed; Device Slipped

  ACCORDING TO THE REPORTER, IN AN OPEN EXPLORATORY LAPAROTOMY ABDOMINAL WALL SURGERY DUE TO BILE DUCT FISTULA, DURING THE CLOSURE OF THE ABDOMINAL WALL, THE THREAD TENDED TO FRAY. THE KNOT DID NOT HOLD THE THREAD. THE THREAD BROKE. THERE WERE A TOTAL OF 6 SUTURES INVOLVED. ANOTHER LOT OF THE SAME SUTURE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16877046 ↗
• InjuryMay 3, 2023Break; Unraveled Material; Break; Unraveled Material

  ACCORDING TO THE REPORTER, SAME DAY POSTOPERATIVE TO EVENTRATION, THE THREAD ON THE ABDOMEN SKIN CLOSURE RUPTURED AT LOWER THIRD AREA, CAUSING ELIMINATION OF CONTENT (EVISCERATION) OF THE INTERIOR OF THE CAVITY. THE PATIENT WAS PLACED IN THE INTENSIVE CARE UNIT AS A RESULT OF THE EVENT WHERE SEDATION OF THE PATIENT FOR A MINOR PROCEDURE WAS PERFORMED.

  Patient problems: Wound Dehiscence

  MAUDE report 16864698 ↗
• MalfunctionOct 18, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING REINTERVENTION OF ABDOMINAL WALL CLOSURE, THE THREAD BROKE.

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

  MAUDE report 15625703 ↗
• InjuryOct 18, 2022Break; Break

  ACCORDING TO THE REPORTER, TWO DAYS POSTOPERATIVE TO GALL DUCT EXPLORATION, EVISCERATION OCCURRED THE THREAD BROKE. REINTERVENTION OF THE NEW ABDOMINAL WALL CLOSURE WAS PERFORMED WITH ANOTHER SUTURE AND FOUND THAT THE INITIAL SUTURE BROKE. THE EVENT LED TO EXTENDED HOSPITALIZATION BY TWO DAYS.

  Patient problems: Wound Dehiscence

  MAUDE report 15620797 ↗
• MalfunctionSep 13, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC PROCEDURE, THE DEVICE NEEDLE AND THREAD BROKE. THE SURGEON THEN USED ANOTHER DEVICE TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12460483 ↗
• MalfunctionApr 23, 2021Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC APPENDIX PROCEDURE, ON FASCIA CLOSURE, THE THREAD BREAKS EASILY WHEN KNOTTING AND PULLING. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE.

  Patient problems: Insufficient Information

  MAUDE report 11716436 ↗
• MalfunctionApr 23, 2021Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC APPENDIX PROCEDURE, ON FASCIA CLOSURE, THE THREAD BREAKS EASILY WHEN KNOTTING AND PULLING. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11713207 ↗
• InjuryOct 31, 2020Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING OPEN HERNIA PROCEDURE, AT THE END OF THE MESH FIXATION, THE THREAD BROKE AND FELL INTO THE CAVITY OF THE PATIENT. THE SURGEON HAD TO FIX AGAIN THE MESH DUE TO THE BREAKAGE OF THE SUTURE AND THE SURGICAL TIME WAS EXTENDED BY MORE THAN 30 MINUTES.

  Patient problems: No Code Available

  MAUDE report 10767335 ↗
• MalfunctionMar 24, 2020Break; Break

  ACCORDING TO THE REPORTER, ON AN OPEN UMBILICAL HERNIA PROCEDURE WITH OBSTRUCTION, DURING THE KNOTTING, THE THREAD OF TWO DEVICES BROKE. THE TECHNIQUE WAS REPEATED AND SURGICAL TIME WAS EXTENDED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9874409 ↗
• MalfunctionJul 13, 2018Break; Loose or Intermittent Connection; Material Too Soft/Flexible; Material Too Soft/Flexible

  ACCORDING TO THE REPORTER, INTRAOPERATIVELY, THE NEEDLE BROKE AND THE SUTURE WAS LOOSE WHEN TYING. THEY OPENED A NEW ONE TO COMPLETE THE CASE. THE PATIENT INJURY WAS ASKED BUT IT WAS UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7687702 ↗
• InjuryMay 9, 2018Break; Detachment Of Device Component; Break; Detachment Of Device Component

  ACCORDING TO THE REPORTER, DURING HERNIA PROCEDURE, WHILE THE DOCTOR WAS FIXING THE MESH WITH THE SUTURE AND ANCHORING, THE THREAD BROKE. THE SUTURE WAS TREATED OR HYDRATED PRIOR TO USE WITH SERUM AND NORMAL SUTURING TECHNIQUE WAS EMPLOYED BY THE SURGEON. THE DEVICE COMPONENT FELL INTO THE PATIENT'S CAVITY AND WAS NOT RETRIEVED. REPLACED BY ANOTHER SUTURE TO COMPLETE THE CASE.

  Patient problems: Foreign Body In Patient

  MAUDE report 7498756 ↗
• DeathMar 29, 2018Break; Unraveled Material; Break; Unraveled Material

  RELEVANT MEDICAL HISTORY: CHEMOTHERAPY AND RADIOTHERAPY TREATMENTS.

  Patient problems: Death; Unspecified Infection

  MAUDE report 7381901 ↗
• MalfunctionSep 26, 2017Break; Break

  PER ADDITIONAL INFORMATION RECEIVED, THERE IS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6893569 ↗
• MalfunctionAug 14, 2017Break; Break

  ACCORDING TO THE REPORTER, THE DEVICE THREAD WAS BROKEN. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY HAS BEEN NOTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6791426 ↗

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