Polysorb L-1796KRecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10884521046351), received between May 25, 2017 and Jan 25, 2024 — classified as 1 injury, 10 malfunctions.

The most frequently reported specific device problem is “Break” (11 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 25, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING AN OPEN RHINOSEPTOPLASTY PROCEDURE, THE NEEDLE BROKE IN HALF WHILE BEING LOADED INTO THE NEEDLE HANDLE. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PAIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18581742 ↗
• MalfunctionApr 19, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE TIP OF THE NEEDLE BROKE OFF. TIP AND ALL PARTS WERE RETRIEVED.

  Patient problems: Insufficient Information

  MAUDE report 14144170 ↗
• MalfunctionMar 23, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING A HYPOSPADIAS REPAIR, THE TIP OF THE NEEDLE BROKE AND THE SURGEON COULD NOT GET IT TO WORK ON THE PROCEDURE.

  Patient problems: Insufficient Information

  MAUDE report 13863073 ↗
• MalfunctionFeb 28, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING OPEN HYPOSPADIAS REPAIR, THE NEEDLE BROKE. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13625852 ↗
• MalfunctionFeb 15, 2022Break; Break

  ACCORDING TO THE REPORTER DURING A PROCEDURE THE DEVICE NEEDLE BROKE. TO RESOLVE THE ISSUE, THE SURGEON USED ANOTHER SUTURE FROM SAME LOT WAS USED SUCCESSFULLY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13539356 ↗
• MalfunctionJul 21, 2021Break; Break

  ACCORDING TO THE REPORTER, WHILE IN THE VESSEL DURING AN EYE MUSCLE PROCEDURE, USING THE SINGLE KNOT TECHNIQUE, THE NEEDLE BROKE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12204242 ↗
• MalfunctionJul 31, 2020Break; Break

  ACCORDING TO THE REPORTER, DURING A CATARACT SURGERY, THE NEEDLE WAS FOUND BROKEN OUT OF THE SURGICAL FIELD. THE REPORTED DEVICE WAS NOT USED ON THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10350021 ↗
• MalfunctionMar 16, 2020Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A ROBOTIC-ASSISTED LAPAROSCOPIC TUBAL ANASTOMOSIS, THE NEEDLE TIP BROKE WHILE SUTURING. THE NEEDLE TIP FELL INTO THE PATIENT'S CAVITY AND WAS RETRIEVED BY THE SURGEON. USED A NEW SUTURE TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9834955 ↗
• MalfunctionDec 13, 2019Break; Break

  ACCORDING TO THE REPORTER, DURING STRABISMUS (EYE) PROCEDURE, WHEN THE SUTURE CAME OUT FROM THE PACKAGE AND BY THE FIRST ATTRACT, THE THREAD OF THE DEVICE BROKE. SURGEON USED ANOTHER DEVICE FROM DIFFERENT LOT NUMBER TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9463734 ↗
• MalfunctionJul 18, 2019Break; Material Frayed; Human-Device Interface Problem; Break; Material Frayed; Human-Device Interface Problem

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE DEVICE HAD AN ISSUE WITH FRAYING, NOT TYING, AND BREAKING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8802766 ↗
• InjuryMay 25, 2017Break; Unraveled Material; Break; Unraveled Material

  ACCORDING TO THE REPORTER: THE PATIENT UNDERWENT AN OPEN TUBE SHUNT EYE PROCEDURE. THE SUTURE WAS USED FOR TYING THE SHUNT. THE SURGEON USED THE STANDARD TECHNIQUE OF THREE THROWS. ONE WEEK POST OPERATION, THE SUTURE THREAD BROKE. THE SUTURE BECAME UNRAVELED AND DEHISCED. THE PATIENT HAD TO COME BACK FOR A REOPERATION. A COMPETITORS SUTURE HAD TO BE USED TO CLOSE THE DEFECT. THERE WAS TEMPORARY INJURY AS A RESULT OF THE EVENT BECAUSE THE WOUND DEHISCED. THIS ALSO RESULTED IN NON-PERMANENT TISSUE DAMAGE. THE PATIENT STATUS IS ALIVE, NO INJURY.

  Patient problems: No Code Available; Tissue Damage; Wound Dehiscence

  MAUDE report 6591844 ↗

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