Polysorb CL-835-LRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10884521042124), received between Oct 5, 2017 and Oct 8, 2024 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Break” (4 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.

• MalfunctionOct 8, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING A VETERINARY PROCEDURE, WHILE SUTURING, THE SUTURE BROKE. A COMPETITOR'S SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20398187 ↗
• MalfunctionSep 24, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING A VETERINARY PROCEDURE, WHILE SUTURING, WHEN THE HORSE WAS CASTRATED, THE SUTURE BROKE. IT OCCURRED ON TWO SUTURES. IT WAS NOTED THAT THE SURGEON USED THE SUTURE TO LIGATE THE SPERMATIC CORD. A COMPETITOR'S SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20297544 ↗
• MalfunctionMay 19, 2021Break; Break

  ACCORDING TO THE REPORT, WHEN THE PRODUCT WAS BEING PREPARED FOR USE INTRA-OPERATIVELY, THE THREAD BROKE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11847787 ↗
• MalfunctionJan 8, 2019Break; Break

  ACCORDING TO THE REPORTER, THE SUTURE BROKE THREE DAYS FOLLOWING A LAPAROSCOPIC LAPAROTOMY PROCEDURE. IT WAS STATED THAT IT WAS FOR THE FASCIAL CLOSURE. THEY USED A DIFFERENT BATCH OF THE SAME PRODUCT TO TREAT THE FASCIA AGAIN.

  Patient problems: No Code Available

  MAUDE report 8229530 ↗
• MalfunctionOct 5, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, THE NEEDLE-THREAD COMBINATION WAS TORN AND WAS DISCERPTED IN TWO CASES. NO FURTHER DETAILS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6915327 ↗

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