Polysorb CL-974Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10884521043855), received between Apr 23, 2025 and Apr 7, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (3 reports).

2 other recalls cover devices cleared under the same FDA submission (K963253, K981935); 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 7, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PROCEDURE, DURING SUTURING OR WHILE PREPARING THE SUTURE AFTER PATIENT INCISION, THE NEEDLE DETACHED FROM THE SUTURE. IT WAS NOTED THAT TWO SUTURES WERE PULLED OFF AT THE SWAGE OF THE NEEDLE WITH LITTLE FORCE. TWO SUTURES WERE USED TO RESOLVE THE ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24799808 ↗
• MalfunctionApr 7, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PROCEDURE, DURING SUTURING OR WHILE PREPARING THE SUTURE AFTER PATIENT INCISION, THE NEEDLE DETACHED FROM THE SUTURE. IT WAS NOTED THAT TWO SUTURES WERE PULLED OFF AT THE SWAGE OF THE NEEDLE WITH LITTLE FORCE. TWO SUTURES WERE USED TO RESOLVE THE ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24799801 ↗
• MalfunctionMay 2, 2025Break; Break

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY OF A C-SECTION, WHILE SUTURING, THE THREAD BROKE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21952928 ↗
• MalfunctionApr 23, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A C-SECTION PROCEDURE, THE NEEDLE DETACHED WHILE SUTURING/PREPARING SUTURE AFTER PATIENT INCISION. THE NEEDLE DID NOT FALL INTO THE PATIENT CAVITY, AND AN ADDITIONAL 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 21888093 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K963253, K981935. One submission often covers many models, so check the product and lot details in each record.

• Z-2601-2018 · Jun 15, 2018 · Terminated
  Polysorb Braided Absorbable Suture 1 36" 90 cm Undyed GS-21, Product Number CL-955
• Z-2541-2017 · May 3, 2017 · Terminated
  Sutures. POLYSORB: POLSORB 0 18 U/D PRECUT 126R, Item Number: L4; POLSORB 0 18 VIO PRECUT 226T; Item Number: L14; POLSORB 0 30 VIO PRECUT 227C, Item Number: L404; POLSORB 1 18 VI