Polysorb UL-212Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10884521049482), received between Mar 8, 2022 and Apr 18, 2022 — classified as 2 injuries, 3 malfunctions.

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

• InjuryApr 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, THE PATIENT HAD AN ANASTOMOSIS PERFORMED ON THEIR BOWEL. ABOUT A WEEK LATER, THE PATIENT WAS HAVING FEVERS AND SHOWING ISSUES. A WEEK AFTER THAT, THE PATIENT TESTED POSITIVE FOR HAVING E-COLI IN THEIR INTESTINES CAUSED BY MICROSCOPIC LEAK. THEY HAD TO RE-ADMIT THE PATIENT A FEW WEEKS POST OPERATIVELY.

  Patient problems: Bacterial Infection; Failure to Anastomose; Fever

  MAUDE report 14139089 ↗
• MalfunctionApr 18, 2022Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING THE FIRST PASS THROUGH INTERRUPTED STITCHING TECHNIQUE IN A OPEN PALATOPLASTY, THE NEEDLE OF THE DEVICE BROKE OFF. THE BROKEN PIECE FELL INTO PATIENT'S CAVITY AND WAS ABLE TO BE RETRIEVED USING A GRASPER. TO RESOLVE THE ISSUE, A NEW SUTURE WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14136362 ↗
• InjuryApr 15, 2022Unraveled Material; Unraveled Material

  ACCORDING TO THE REPORTER, FOLLOWING A LAPAROSCOPIC SIGMOID ANASTOMOSIS, THE PATIENT HAD TO HAVE A REOPERATION ON THE ANASTOMOSIS AS THERE WAS A LEAK. THE CASE WAS COMPLETED, AND THE COMPLICATIONS WERE OBSERVED POST-OPERATIVELY. THE PATIENT ALSO HAD AN EXTENDED HOSPITAL STAY AND WAS PLACED ON NEONATAL INTENSIVE CARE UNIT.

  Patient problems: Failure to Anastomose; Unspecified Tissue Injury

  MAUDE report 14117996 ↗
• MalfunctionApr 12, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING AN OPEN PALATOPLASTY PROCEDURE, WHILE THE SUTURE INTRAOPERATIVE WAS ON FIRST PASS, THE NEEDLE WAS BROKEN. ANOTHER SUTURE WAS PULLED TO COMPLETE THE CASE AND RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14084253 ↗
• MalfunctionMar 8, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING AN OPEN PROCEDURE, THE NEEDLE BROKE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13693885 ↗

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