Surgipro SP-665GRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10884521037427), received between Aug 2, 2018 and Dec 3, 2025 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Break” (3 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.

• MalfunctionDec 3, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE NEEDLE BROKE OFF THE SUTURE MATERIAL WHILE SUTURING A PATIENT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23702378 ↗
• InjuryJun 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, POST-OPERATIVELY, THE PATIENT HAD THREE DEHISCENCE IN A WEEK.

  Patient problems: Wound Dehiscence

  MAUDE report 14807207 ↗
• MalfunctionApr 21, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING A BILATERAL BREAST IMPLANT PROCEDURE, WHILE SUTURING DRAIN IN PLACE, TIP OF NEEDLE BROKE OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14180360 ↗
• MalfunctionAug 16, 2021Break; Break

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY OF A BILATERAL MASTOPEXY, DURING THE CLOSING INCISION, THE THREADS OF 2 SUTURES BROKE. STAPLES WAS USED TO HOLD BREAST SKIN IN PLACE INSTEAD. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12324356 ↗
• MalfunctionAug 2, 2018Break; Material Separation; Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, THE FIRST TWO NEEDLES BROKE AND THE SUTURE MATERIAL WAS SEPARATED FROM NEEDLES WHEN THEY OPENED THE BOX.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7742196 ↗

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