Polysorb GL-182-MRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10884521045071), received between Jul 11, 2018 and Jul 15, 2024 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (3 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.

• MalfunctionJul 15, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PREOPERATIVELY, WHEN THE NURSE UNPACKED THE PACKAGE, IT WAS FOUND THAT THE NEEDLE AND SUTURE DETACHED OUTSIDE THE HOLDER/RETAINER. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19739820 ↗
• MalfunctionJul 1, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, AFTER UNPACKING, THE NEEDLE AND THREAD WERE FOUND DETACHED. THE SUTURE WAS NOT USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19643314 ↗
• MalfunctionSep 20, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING THORACOSCOPIC LOBECTOMY, WHEN IN THE PROCESS OF SUTURING, THE NEEDLE BROKE WHEN THE NEEDLE WAS WITHDRAWN, AND THE SURGEON PAUSED THE OPERATION AND SEARCHED FOR THE BROKEN NEEDLE TIP WITH HIS ASSISTANT, THEN FOUND THE BROKEN NEEDLE TIP AND CONTINUED THE OPERATION AND THE COMPARATIVE FRACTURE WAS CORRECT. THERE WAS NO PATIENT INJURY.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17782055 ↗
• InjuryJul 11, 2018Break

  ACCORDING TO THE REPORTER, DURING ANASTOMOSIS AND REINFORCEMENT IN A RECTAL TUMOR SURGERY, AFTER THE SECOND STITCH IN A U SHAPE AND THE SUTURE WAS TIED. THEY NOTICED A 1 MM DEFECT ON THE NEEDLE AND THE STITCHES BROKE THROUGH THE NEEDLE HOLDER. THEY ALSO CONFIRMED THRU X-RAY THAT THERE WAS NO BROKEN NEEDLE IN THE STUMP OF THE ANASTOMOSIS AND THERE WAS NO METAL FOREIGN BODY RETAINED IN THE ABDOMINAL CAVITY AND ANASTOMOTIC MOUTH. THEY WASHED THE ABDOMINAL CAVITY TO PREVENT RETENTION OF SMALL METAL.

  Patient problems: No Code Available; Radiation Exposure, Unintended

  MAUDE report 7679404 ↗

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