Polysorb CLT-11-MGRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10884521044500), received between Jul 24, 2019 and Aug 28, 2024 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (4 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.

• InjuryAug 28, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, DURING CLOSURE, A BROKEN NEEDLE TIP WAS FOUND OUTSIDE THE BODY OF THE PATIENT. NO DEVICE COMPONENT FELL INTO THE CAVITY OF THE PATIENT. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unintended Radiation Exposure

  MAUDE report 20089272 ↗
• MalfunctionJan 26, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING A CAESAREAN SECTION, WHEN THE MYOMETRIUM WAS SUTURED BY INTERRUPTED SUTURING, THE TIP OF THE NEEDLE WAS GRASPED AND WAS ATTEMPTED TO BE PULLED OUT OF THE TISSUE, HOWEVER THE TIP OF THE NEEDLE WAS LEFT IN THE NEEDLE HOLDER. THE NEEDLE WITH THE CHIPPED TIP WAS ABLE TO BE PULLED OUT OF THE TISSUE WITHOUT ANY PROBLEMS. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18592005 ↗
• InjuryJul 24, 2023Break; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Break; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROTOMY CESAREAN SECTION, DURING SUTURING THE UTERINE MYOMETRIUM, THE NEEDLE FLEW WHEN D-TACH WAS PERFORMED. THE NEEDLE BROKE, AND THE TIP OF THE NEEDLE FELL INTO THE PATIENT'S CAVITY. AN X-RAY WAS PERFORMED, AND THE TIP OF THE NEEDLE REVEALED THAT IT WAS IMPLANTED IN THE MYOMETRIUM. THE NEEDLE TIP WAS NOT RETRIEVED, CAUSING THE SURGICAL TIME TO BE EXTENDED FOR AT LEAST 30 MINUTES. IT WAS NOTED THERE WERE NO PLANS FOR TREATMENT.

  Patient problems: Foreign Body In Patient; Unintended Radiation Exposure

  MAUDE report 17381592 ↗
• MalfunctionJul 24, 2019Break; Break

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE NEEDLE BROKE. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8824331 ↗

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