Polysorb CL-928Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10884521043459), received between Aug 9, 2018 and Aug 9, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Unraveled Material” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryAug 9, 2018Unraveled Material; Unraveled Material

  ACCORDING TO THE REPORTER, THE PATIENT WAS OPERATED WITH MULTIPLE LEFT PULMONARY (ONCOLOGICAL) RESECTIONS BY MINI THORACOTOMY, DURING THE WEEKEND, THE PATIENT HAD A PROGRESSIVE SUBCUTANEOUS EMPHYSEMA AND A THORACOTOMY DEHISCENCE WITH PULMONARY HERNIATION, THAT WAS CONFIRMED BY CT SCAN, THE PATIENT HAD TO UNDERGO MINI THORACOTOMY BECAUSE OF RUPTURED SUTURES. THIS WAS VERIFIED ON THE 6TH POSTOPERATIVE DAY DURING PATIENT REOPERATION. UPON REACHING THE PLANE OF THE THORACOTOMY, THE RUPTURE (TEAR) OF THE THREE SUTURES IN "X" WAS VERIFIED FOR THE COSTAL APPROACH, WITH INTEGRITY OF THE SURGICAL KNOTS. THE SUTURES WERE SEPARATED FROM EACH OTHER SEVERAL CENTIMETERS AND WERE NOT EXPOSED TO ANY CUTTING OR EROSIVE STRUCTURE, SO THAT ONLY A MATERIAL FAILURE IS PLAUSIBLE. THE PATIENT IS STILL HOSPITALIZED.

  Patient problems: Hernia; No Code Available; Radiation Exposure, Unintended; Wound Dehiscence

  MAUDE report 7768507 ↗

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