Surgipro CP-411Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10884521036116), received between Jun 4, 2018 and Mar 24, 2026 — classified as 5 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 18, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 24, 2026Break

  ACCORDING TO THE REPORTER, DURING ROBOTIC LAPAROSCOPIC HYSTERECTOMY, OOPHORECTOMY, SACROCOLPOPEXY, AND LYSIS OF ADHESIONS, WHILE SUTURING, THE THREAD BROKE IN THE MIDDLE. ANOTHER SUTURE WAS USED WITHOUT ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24673847 ↗
• MalfunctionMar 25, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, WHEN CLOSING THE TISSUE, THE THREAD BROKE. ANOTHER SUTURE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18974753 ↗
• MalfunctionMar 25, 2024Break; Break

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18972324 ↗
• MalfunctionDec 13, 2018Break; Break

  ACCORDING TO THE REPORTER, 10 MINUTES INTO AN OPEN ANASTOMOSIS PROCEDURE, WHILE EMPLOYING AN INTERRUPTED SUTURING TECHNIQUE, THE THREAD BROKE OFTEN WHEN MAKING KNOTS. THE DEVICE WAS REPLACED TO COMPLETE THE CASE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8160113 ↗
• MalfunctionJun 4, 2018Detachment of Device or Device Component; Difficult to Open or Remove Packaging Material; Detachment of Device or Device Component; Difficult to Open or Remove Packaging Material

  ACCORDING TO THE REPORTER, PRIOR TO USE, WHEN PREPARING THE OPERATION, THE SCRUB NURSE WANTED TO TAKE OUT THE SUTURE OF THE PACKAGING, THE NEEDLES WERE VERY HARD TO TAKE OUT. WHEN THE NEEDLE WAS PULLED OUT OF THE PACKAGING, THE NEEDLE AND THE THREAD SEPARATED FROM EACH OTHER. IT WAS REPORTED THAT THIS HAPPENS QUITE OFTEN, THAT NEEDLES ARE VERY HARD TO PULL OUT OF THE PACKAGING. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Patient Involvement

  MAUDE report 7565373 ↗

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