Polysorb SL-1689Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10884521047556), received between Aug 7, 2019 and Feb 25, 2025 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 25, 2025Break; Break

  IT WAS REPORTED THAT DURING A PROCEDURE, WHILE SUTURING, THE NEEDLE BROKE AND FELL INTO THE PATIENT'S CAVITY. THE NEEDLE WAS SUCCESSFULLY LOCATED USING X-RAY IMAGING AND WAS RETRIEVED. TO COMPLETE THE CASE, AN ADDITIONAL SUTURE WAS USED.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 21463282 ↗
• MalfunctionFeb 23, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN OPEN WOUND CLOSURE, THERE WAS SEPARATION OF NEEDLE AND THREAD WHILE ON WOUND SUTURING. NO DEVICE COMPONENT FELL INTO THE CAVITY OF THE PATIENT. A NEW ENVELOPE OF SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18773872 ↗
• MalfunctionAug 7, 2019Break; Break

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, UPON OPENING THE PRODUCT THE DEVICE THREAD BROKE. THE SURGEON THE USED ANOTHER DEVICE TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8872078 ↗

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