Polysorb CLT-15-MGRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10884521044524), received between May 26, 2021 and Nov 21, 2024 — classified as 1 injury, 3 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.

• MalfunctionNov 21, 2024Component Missing; Component Missing

  ACCORDING TO THE REPORTER, PRIOR TO SUTURING THE VAGINAL STUMP, IT WAS FOUND THAT ONE SUTURE NEEDLE WAS MISSING FROM THE PACKAGING, ANOTHER PACK WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20745722 ↗
• InjuryJul 12, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A CESAREAN SECTION MYOMETRIAL SUTURE, THE NEEDLE BROKE WHEN THE SUTURE WAS DETACHED. THE TIP OF THE NEEDLE BROKE AT THE SAME TIME AS THE DETACHMENT, SO THE BROKEN NEEDLE FLEW OFF. THE BROKEN NEEDLE WAS FOUND IMMEDIATELY, BUT IT WAS WASHED TO FIND THE RUPTURED TIP, AND AN X-RAY WAS TAKEN, BUT IT COULD NOT BE FOUND. SURGICAL TIME WAS EXTENDED BY 30 MINUTES. THE NURSE FOUND THAT IT WAS ATTACHED TO THE SURGICAL DRAPE.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 19735906 ↗
• MalfunctionMay 16, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING CAESAREAN SECTION VIA LAPAROTOMY, AFTER SUTURING THE UTERUS, THE TIP OF THE NEEDLE BROKE. NO DEVICE COMPONENT FALL INTO THE PATIENT'S CAVITY. A NEW NEEDLE WAS THEN USED TO CONTINUE SUTURING AND COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16943263 ↗
• MalfunctionMay 26, 2021Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, THERE WERE ONLY 4 SUTURES INSTEAD OF 5 IN THE 2 PACKAGES. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11882390 ↗

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