Polysorb SL-611Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10884521048898), received between Oct 28, 2019 and May 31, 2023 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 31, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING AN OPEN PROCEDURE, THE NEEDLE OF THE DEVICE BROKE. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17032169 ↗
• MalfunctionFeb 9, 2021Unraveled Material; Unraveled Material

  ACCORDING TO THE REPORTER, TWO DAYS POST-OPERATIVELY, A STERILIZATION PROCEDURE OF THE DOG, IT WAS NOTICED THAT THE WOUND WAS SWOLLEN. ON ANOTHER APPOINTMENT ABOUT FOUR DAYS POST-OPERATIVELY, IT WAS NOTED THAT THERE WAS A DEHISCENCE OF THE LINEA ALBA SUTURES. THE MIDDLE CONTINUOUS LAYER OF THE SUTURE HAD COMPLETELY PULLED APART, BOTH KNOTS WERE STILL FIRMLY IN PLACE BUT THE SUTURE MATERIAL HAD BROKEN OFF JUST CAUDAL TO CRANIAL KNOT. A REPAIR SURGERY WAS DONE AND ALL ORGANS WERE CHECKED AND THE ANASTOMOSIS WAS RE-SUTURED USING A DIFFERENT SUTURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Swelling/ Edema; Wound Dehiscence

  MAUDE report 11303020 ↗
• InjuryOct 28, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, FOLLOWING WOUND CLOSURE ON AN OPEN PROCEDURE, COMPLICATION SUCH AS INFECTIONS WERE OBSERVED.

  Patient problems: Impaired Healing; Post Operative Wound Infection

  MAUDE report 9244276 ↗

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