Surgipro CP-425Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 30884523004377), received between Jun 12, 2019 and Mar 7, 2026 — classified as 6 injuries, 18 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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 7, 2026Break

  ACCORDING TO THE REPORTER DURING A PROCEDURE, THE SUTURE BROKE.

  Patient problems: Insufficient Information

  MAUDE report 24540992 ↗
• MalfunctionMar 7, 2026Break

  ACCORDING TO THE REPORTER DURING A PROCEDURE, THE SUTURE BROKE.

  Patient problems: Insufficient Information

  MAUDE report 24540760 ↗
• InjuryMar 3, 2026Break

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, AFTER CLOSING THE ABDOMINAL WALL USING A VACUUM-ASSISTED CLOSURE SYSTEM AND PREPARING TO CLEAN AND DRESS THE WOUND, THE SUTURE BROKE EVEN THOUGH IT WAS NOT UNDER TENSION. TWO MORE SUTURES WERE REQUIRED TO RESOLVE THE ISSUE, AND THE SURGICAL TIME WAS EXTENDED MORE THAN 30 MINUTES. THE PATIENT WAS CURRENTLY IN THE INTENSIVE CARE UNIT AND STABLE, ALTHOUGH THE PATIENT¿S SKIN WAS VERY DELICATE DUE TO MULTIPLE PROCEDURES. THE ISSUE LED TO PROLONG PATIENT HOSPITALIZATION.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 24498599 ↗
• MalfunctionFeb 20, 2026Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A RIGHT HEPATECTOMY WITH SEVERE LIVER TRAUMA AND A RUPTURED RIGHT LOBE, THE NEEDLE WAS BENT ON THE FIRST ATTEMPT AT INSERTION, REQUIRING GREATER FORCE THAN USUAL, WHICH GENERATED TECHNICAL DIFFICULTY. IT WAS NOTED THAT TWO SUTURES WERE USED AND HAD THE SAME ISSUE. ANOTHER TWO SUTURES WERE USED BUT THE NEEDLE DETACHED FROM THE THREAD.

  Patient problems: Insufficient Information

  MAUDE report 24404569 ↗
• MalfunctionFeb 16, 2026Dull, Blunt; Material Twisted/Bent; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A SKIN CLOSURE PROCEDURE, THE AREA WHERE THE SKIN WAS BEING CLOSED WAS DESCRIBED AS VERY WIDE, AND THE NEEDLE BENT WHILE PLACING THE FIRST STITCH, CAUSING DIFFICULTY IN ITS PASSAGE AND DAMAGING THE TISSUES TO BE APPROXIMATED.

  Patient problems: Tissue Breakdown

  MAUDE report 24349815 ↗
• MalfunctionFeb 16, 2026Dull, Blunt; Material Twisted/Bent; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A SKIN CLOSURE PROCEDURE, THE SUTURE NEEDLE BENT, WHICH CAUSED DIFFICULTY IN PASSING THE NEEDLE AND RESULTED IN TISSUE INJURY. THE AREA WHERE THE SKIN WAS BEING CLOSED WAS DESCRIBED AS VERY WIDE, AND THE NEEDLE BENT WHILE PLACING THE FIRST STITCH, LEADING TO INJURY OF THE TISSUES BEING APPROXIMATED.

  Patient problems: Tissue Breakdown

  MAUDE report 24348677 ↗
• MalfunctionDec 3, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ABDOMINOPLASTY PROCEDURE, WHILE SUTURING, NEEDLE DETACHMENT OCCURRED ON THE TWO DEVICES. THE NEEDLE DID NOT FALL INTO THE PATIENT CAVITY. A NEW SUTURE 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 23708937 ↗
• MalfunctionDec 3, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ABDOMINOPLASTY PROCEDURE, WHILE SUTURING, NEEDLE DETACHMENT OCCURRED ON THE TWO DEVICES. THE NEEDLE DID NOT FALL INTO THE PATIENT CAVITY. A NEW SUTURE 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 23708896 ↗
• MalfunctionMar 14, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, WHEN THE SURGEON WAS TRYING TO TIE THE SUTURE, THE TWO STRANDS BROKE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16539305 ↗
• MalfunctionMay 11, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC APPENDECTOMY, AT THE END, THE THREAD OF THE THREE DEVICES BROKE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14366384 ↗
• MalfunctionMay 11, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC APPENDECTOMY, AT THE END, THE THREAD OF THE THREE DEVICES BROKE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14366371 ↗
• MalfunctionMay 11, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC APPENDECTOMY, AT THE END, THE THREAD OF THE THREE DEVICES BROKE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14366353 ↗
• MalfunctionNov 19, 2021Break; Break

  ACCORDING TO THE REPORTER, AT THE END OF A PLASTIC SURGERY, THE THREAD OF THE DEVICE WAS BROKEN. TO RESOLVE THE ISSUE, OTHER SUTURE WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12844394 ↗
• MalfunctionMay 26, 2021Break; Break

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE THREAD EASILY BROKE AND WAS TOUCHED WITH GLOVES BY THE OPERATOR. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11890066 ↗
• MalfunctionMay 18, 2021Break; Material Twisted/Bent; Break; Material Twisted/Bent

  ACCORDING TO THE REPORTER, DURING A DIAGNOSTIC LAPAROSCOPY WITH OPEN HERNIA REPAIR, WHILE CLOSING A FASCIAL DEFECT USING A RUNNING STITCH, TWO SUTURES BROKE. THE FIRST ONE'S SUTURE BROKE AND THE NEEDLE BENT. THE SECOND ONE'S SUTURE BROKE WHEN TYING TO KNOT. THE USER OPENED ANOTHER SUTURE PACKET TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY. .

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11841015 ↗
• MalfunctionApr 4, 2021Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC BOWEL RECONNECTION, THE 3 SUTURES WERE PASSED AND WERE BROKEN, THE FOURTH SUTURE WAS ALREADY USED WITHOUT ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11611956 ↗
• InjuryFeb 18, 2021Break; Break

  ACCORDING TO THE REPORTER, POST-OPERATIVELY ON AN OPEN COLOSTOMY PROCEDURE, THE DEVICE THREAD BROKE AND FELL TO THE CAVITY THAT CAUSED WOUND DEHISCENCE AND BLEEDING. THE PATIENT HAD TO UNDERGO ANOTHER PROCEDURE TO RESOLVE THE ISSUE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Unspecified Tissue Injury; Wound Dehiscence

  MAUDE report 11342239 ↗
• MalfunctionSep 11, 2020Break; Break

  ACCORDING TO THE REPORTER, THE SUTURE STRAND BROKE.

  Patient problems: No Consequences Or Impact To Patient; No Information

  MAUDE report 10525295 ↗
• MalfunctionMar 25, 2020Break; Break

  ACCORDING TO THE REPORTER, WHEN CLOSING THE FASCIA USING INTERRUPTED SUTURE TECHNIQUE DURING A LAPAROSCOPIC HERNIA REPAIR, THE THREAD BROKE WHEN THE SURGEON PUSHED TWO KNOTS FURTHER DOWN TO CINCH THE INCISION. ANOTHER DEVICE WITH THE SAME PRODUCT ID AND LOT NUMBER WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9876628 ↗
• InjurySep 19, 2019Unraveled Material; Unraveled Material

  ACCORDING TO THE REPORTER, AFTER AN OPEN RIGHT HEMICOLECTOMY PROCEDURE, ONE DEVICE HAD SUTURE BROKE AFTER THE PROCEDURE, AND THREE OTHER SUTURES THAT WERE USED ON THE PATIENT ALSO BROKE, SIX DAYS POST-OPERATIVELY. TO RESOLVE THE ISSUE, THE PATIENT NEEDS TO UNDERGONE ARE-OPERATION WHICH THE SURGEON PERFORMED EVISCERATION AT THE SITE OF THE WOUND CLOSURE. THE SURGICAL TIME EXTENDED FOR ABOUT 1 AND HALF HOURS AND THE PATIENT EXTENDED HOSPITAL STAY FOR FIVE MORE DAYS DUE TO THE DEVICE PROBLEM.

  Patient problems: No Code Available

  MAUDE report 9087099 ↗
• InjurySep 19, 2019Unraveled Material; Unraveled Material

  ACCORDING TO THE REPORTER, AFTER AN OPEN RIGHT HEMICOLECTOMY PROCEDURE, ONE DEVICE HAD SUTURE BROKE AFTER THE PROCEDURE, AND THREE OTHER SUTURES THAT WERE USED ON THE PATIENT ALSO BROKE, SIX DAYS POST-OPERATIVELY. TO RESOLVE THE ISSUE, THE PATIENT NEEDS TO UNDERGONE ARE-OPERATION WHICH THE SURGEON PERFORMED EVISCERATION AT THE SITE OF THE WOUND CLOSURE. THE SURGICAL TIME EXTENDED FOR ABOUT 1 AND HALF HOURS AND THE PATIENT EXTENDED HOSPITAL STAY FOR FIVE MORE DAYS DUE TO THE DEVICE PROBLEM.

  Patient problems: No Code Available

  MAUDE report 9087041 ↗
• InjuryAug 30, 2019Break; Break

  ACCORDING TO THE REPORTER, POST OPERATIVELY, ON AN EXPLORATORY LAPAROTOMY, THE THREAD BROKE. THE INCISION WAS EXTENDED LESS THAN 2.4CM. THE SURGEON FINISHED THE PROCEDURE AND TEN DAYS LATER THEY HAD TO PERFORM ANOTHER SURGERY THAT LASTED ABOUT ONE HOUR BECAUSE OF THE BROKEN STRAND. THE WAS EVENTRATION. THERE WAS PATIENT INJURY.

  Patient problems: Injury; No Code Available

  MAUDE report 8949789 ↗
• InjuryAug 30, 2019Break; Break

  ACCORDING TO THE REPORTER, POST OPERATIVELY, ON AN EXPLORATORY LAPAROTOMY, THE THREAD BROKE ON TWO PATIENTS. THE SURGICAL TIME WAS EXTENDED BY THIRTY MINUTES OR MORE. THE INCISION WAS EXTENDED. THE SURGEON FINISHED THE PROCEDURE AND TEN DAYS LATER THEY HAD TO PERFORM ANOTHER SURGERY BECAUSE OF THE BROKEN STRAND. THERE WAS EVENTRATION AND A BIGGER SCAR AND TIME RECOVERING.

  Patient problems: Injury; No Code Available; Scarring

  MAUDE report 8949785 ↗
• MalfunctionJun 12, 2019Break; Break

  ACCORDING TO THE REPORTER, DURING OPEN PERITONEAL THERAPEUTIC PROCEDURE, WHILE CLOSING, THE DEVICE THREAD BROKE. REPLACEMENT FOR ANOTHER UNIT WAS DONE TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8693854 ↗

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