Polysorb CL-839Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10884521042209), received between Oct 23, 2019 and May 29, 2026 — classified as 5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 29, 2026Detachment of Device or Device Component; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING AN AORTIC VALVE REPLACEMENT, WHILE SUTURING OR PREPARING THE SUTURE AFTER A PATIENT INCISION, THE NEEDLE SNAPPED/DETACHED FROM THE SUTURE WITH MINIMAL FORCE. THE NEEDLE REPORTEDLY DID NOT FALL INTO THE PATIENT CAVITY. IT WAS REPORTED THAT TWO SUTURES WERE INVOLVED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 25334236 ↗
• MalfunctionMay 29, 2026Detachment of Device or Device Component; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING AN AORTIC VALVE REPLACEMENT, WHILE SUTURING OR PREPARING THE SUTURE AFTER A PATIENT INCISION, THE NEEDLE SNAPPED/DETACHED FROM THE SUTURE WITH MINIMAL FORCE. THE NEEDLE REPORTEDLY DID NOT FALL INTO THE PATIENT CAVITY. IT WAS REPORTED THAT TWO SUTURES WERE INVOLVED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 25334195 ↗
• MalfunctionDec 5, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A CESAREAN SECTION, THERE WAS A PROCEDURAL/DEVICE-RELATED ISSUE INVOLVING THE CL-839 POLYSORB SUTURE. TH E NEEDLE DETACHED FROM THE SUTURE WHILE SUTURING/PREPARING THE SUTURE AFTER THE PATIENT INCISION. IT WAS CONFIRMED THAT THE NEEDLE DID NOT FALL INTO THE PATIENT CAVITY. 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 20856015 ↗
• MalfunctionOct 24, 2019Break; Break

  ACCORDING TO THE REPORTER, DURING AN ABDOMINAL HYSTERECTOMY PROCEDURE, THE SUTURE'S NEEDLE WAS BROKEN. A DIFFERENT SUTURE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9236368 ↗
• MalfunctionOct 23, 2019Break; Break

  ACCORDING TO THE REPORTER, DURING AN ABDOMINAL HYSTERECTOMY PROCEDURE, THE SUTURE NEEDLE WAS BROKEN. A DIFFERENT SUTURE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9227665 ↗

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