Polysorb SL-1625Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10884521047297), received between Apr 15, 2022 and Apr 15, 2022 — 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. How this data works · Data updated Oct 13, 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.

• 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 14118036 ↗

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