Surgipro SP-665Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10884521037410), received between Sep 28, 2017 and Sep 20, 2023 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (6 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 20, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A BACK LIPOMA PROCEDURE, WHILE CLOSING THE WOUND, THE NEEDLE DETACHED FROM THE SUTURE. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17785606 ↗
• MalfunctionJun 18, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE NEEDLES ARE BREAKING WHEN THEY ATTACH TO THE THREAD WITHOUT ANY TENSION. IT WAS ALSO REPORTED THAT THE NEEDLE HAD FALLEN OFF THE THREAD EVEN BEFORE IT REMOVES FROM ITS PACKAGING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8707848 ↗
• MalfunctionJun 18, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE NEEDLES ARE BREAKING WHEN THEY ATTACH TO THE THREAD WITHOUT ANY TENSION. IT WAS ALSO REPORTED THAT THE NEEDLE HAD FALLEN OFF THE THREAD EVEN BEFORE IT REMOVES FROM ITS PACKAGING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8707832 ↗
• MalfunctionApr 30, 2019Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE NEEDLES ARE BROKEN WHEN THEY ATTACH TO THE THREAD WITHOUT ANY TENSION. IT WAS ALSO REPORTED THAT THE NEEDLE HAD FALLEN OFF THE THREAD EVEN BEFORE IT REMOVES FROM ITS PACKAGING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8565995 ↗
• MalfunctionApr 8, 2019Break; Break

  ACCORDING TO THE REPORTER, AFTER THE FIRST OR SECOND STITCH DURING SKIN CLOSURE ON AN OPEN PROCEDURE, THE THREAD BROKE. A NEW DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8492902 ↗
• MalfunctionApr 26, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN OPEN PLASTIC SURGERY PROCEDURE, THE THREAD BROKE AND TWO SUTURE NEEDLES DETACHED PREMATURELY IN TWO CASES. TO COMPLETE THE PROCEDURE, A NEW SUTURE WAS OPENED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7464999 ↗
• MalfunctionOct 18, 2017Break; Break

  ACCORDING TO THE REPORTER, THE DEVICE¿S THREAD BROKE WHILE BEING USED FOR SKIN CLOSURE. THERE WILL BE AN ADDITIONAL OPERATION PERFORMED TO CORRECT THE ISSUE. NEW DEVICE WAS USED TO COMPLETE THE CASE. PATIENT STATUS AND OUTCOME WERE UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6959886 ↗
• MalfunctionSep 28, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING THE BUNIONECTOMY PROCEDURE, THE NEEDLE POPPED OFF THE THREAD. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. NO PATIENT ADVERSE EVENTS REPORTED. PATIENT IS STABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6901474 ↗

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