Polysorb CL-885Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10884521042797), received between Apr 9, 2018 and Oct 18, 2024 — classified as 2 injuries, 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 18, 2024Break; Break

  ACCORDING TO THE REPORTER, IN A LAPAROSCOPIC ABDOMINAL HYSTERECTOMY, WHILE CLOSING THE VAGINAL VAULT, THE TIP OF TWO NEEDLES BROKE WHILE SUTURING. ONE TIP WAS FOUND IN THE STERILE SHARPS TRAY ON THE TROLLEY AND THE OTHER WENT MISSING. AN X-RAY WAS DONE INTRAOPERATIVELY TO SCAN THE PELVIC AREA TO LOCATE THE NEEDLE. A THOROUGH INSPECTION OF THE OPEN CAVITY WAS PERFORMED.

  Patient problems: Insufficient Information

  MAUDE report 20488849 ↗
• InjurySep 26, 2024Break; Break

  ACCORDING TO THE REPORTER, IN A LAPAROSCOPIC ABDOMINAL HYSTERECTOMY, WHILE CLOSING THE VAGINAL VAULT, THE TIP OF THE NEEDLE BROKE WHILE SUTURING. THE NEEDLE FELL INTO THE CAVITY AND WENT MISSING. AN X-RAY WAS DONE INTRAOPERATIVELY TO SCAN THE PELVIC AREA TO LOCATE THE NEEDLE. A THOROUGH INSPECTION OF THE OPEN CAVITY WAS PERFORMED. THE SURGICAL TIME WAS EXTENDED FOR APPROXIMATELY ONE HOUR.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 20313795 ↗
• InjuryMay 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, FOLLOWING THE OPEN CERVICAL FUSION, THE PATIENT EXPERIENCE WOUND DEHISCENCE AND SENSITIVITY USING THE TWO SUTURES.

  Patient problems: Local Reaction; Wound Dehiscence

  MAUDE report 16879433 ↗
• MalfunctionApr 9, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, DURING SUTURING, THE NEEDLE DETACHED. NO PATIENT HARM REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7409441 ↗

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