Polysorb CL-884Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10884521042780), received between Jul 2, 2019 and Nov 18, 2025 — classified as 2 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Break” (7 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.

• MalfunctionNov 18, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC ADENOMYOMECTOMY DUE TO UTERINE ADENOMYOMA, THE SUTURE WAS USED TO CLOSE THE LEFT ABDOMINAL WALL INCISION. FOUR DAYS AFTER SURGERY, THE PATIENT EXPERIENCED NO DISCOMFORT, THE INCISION HEALED WELL, AND THE PATIENT WAS DISCHARGED. ON THE 56TH DAY POST-SURGERY, THE PATIENT NOTICED REDNESS AND SWELLING PAIN AT THE LEFT ABDOMINAL WALL INCISION SITE. ON THE MORNING 11 DAYS LATER, SHE PRESENTED FOR EVALUATION. EXAMINATION REVEALED REDNESS OF ABOUT 0.5 CENTIMETER (CM) AT THE UMBILICAL INCISION, SLIGHT PROTRUSION, AND TENDERNESS. SUTURE REACTION WAS CONSIDERED. AFTER LOCAL ANESTHESIA, THE INCISION WAS OPENED, AND THE SUTURE KNOT WAS REMOVED. THE WOUND WAS COVERED WITH STERILE GAUZE, AND THE PATIENT WAS ADVISED TO RETURN FOR A FOLLOW-UP IN TWO DAYS. AT THE FOLLOW-UP VISIT 6 DAYS LATER, THE ABDOMINAL INCISION HAD HEALED WELL, WITH NO REDNESS, SWELLING, OR PAIN.

  Patient problems: Inflammation; Pain

  MAUDE report 23579620 ↗
• MalfunctionNov 22, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, LAPAROSCOPIC TOTAL HYSTERECTOMY, DURING SUTURING, THE THREAD FELL OFF FROM THE TAIL END OF THE NEEDLE. THE DOCTOR IMMEDIATELY REMOVED THE FALLEN SUTURE NEEDLE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20758673 ↗
• MalfunctionJun 3, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC MYOMECTOMY PROCEDURE, AT THE TIME OF PERFORMING CONTINUOUS SUTURING, THE THREAD BROKE. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19445165 ↗
• MalfunctionMay 23, 2024Break; Product Quality Problem; Break; Product Quality Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC MYOMECTOMY, SYNTHETIC ABSORBABLE SURGICAL SUTURES WERE USED TO SUTURE THE MYOMETRIUM. UNDER NORMAL USE, THE SUTURES WERE PARTIALLY BROKEN AND ROUGH. SYNTHETIC ABSORBABLE SURGICAL SUTURES WERE REPLACED AND RE-SUTURED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19383850 ↗
• MalfunctionDec 18, 2023Break; Detachment of Device or Device Component; Material Twisted/Bent; Break; Detachment of Device or Device Component; Material Twisted/Bent

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, WHEN SUTURING THE UTERUS, THE SUTURE BROKE AND THE NEEDLE BENT. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

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

  MAUDE report 18348359 ↗
• MalfunctionOct 12, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, WHEN STITCHING WITH THE SECOND NEEDLE, THE LINE BREAKS VERY CLOSE TO THE NEEDLE'S TIP. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17919517 ↗
• MalfunctionNov 8, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING THE PATIENT'S SUB-ABDOMINAL UTERINE FIBROIDS MYOMECTOMY, WHEN SUTURING THE MYOMETRIUM, THE SUTURE BROKE, CAUSING THE SUTURE TO BE INCOHERENT. AFTER THE SURGEON HANDLED THE BROKEN END, CHECKED THE CONDITION OF THE SUTURED INCISIONAGAIN. CONTINUED TO SUTURE THE INCISION. THERE WAS NO PATIENT INJURY.

  Patient problems: Insufficient Information

  MAUDE report 15757132 ↗
• InjuryOct 3, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, THE NEEDLE HAD SEPARATED FROM THE THREAD WHEN SEWING THROUGH THE SKIN. THE LAPAROSCOPIC PROCEDURE CONVERTED TO OPEN DUE TO DEVICE PROBLEM.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 15528669 ↗
• MalfunctionFeb 15, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING A ROBOTIC LAPAROSCOPIC PROCEDURE, WHILE CLOSING THE COLPOTOMY, THE SUTURE WAS BROKEN. THE ROBOTIC INSTRUMENT ARM CANNOT CUT THE SUTURE. CONTINUED TO FINISH COLPOTOMY TO COMPLETE THE CASE AND RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13538794 ↗
• MalfunctionFeb 11, 2022Break; Mechanics Altered; Break; Mechanics Altered

  ACCORDING TO THE REPORTER, DURING COLPOTOMY CLOSURE DURING A ROBOTIC LAPAROSCOPIC GYN PROCEDURE, THE THREAD OF THE DEVICE BROKE. THE SURGEON USED ANOTHER SUTURE TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13518188 ↗
• InjuryJul 2, 2019Break; Dull, Blunt; Detachment of Device or Device Component; Break; Dull, Blunt; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC TOTAL HYSTERECTOMY, WHILE SUTURING THE VAGINAL STUMP, THE NEEDLE BECAME BLUNT. AFTER REMOVING THE NEEDLE, IT WAS FOUND THAT THE TIP OF THE NEEDLE WAS DAMAGED. THE HAND-WASHING NURSE FOUND THE NEEDLE DEFECTED DURING THE NEEDLE EXAMINATION, AND IMMEDIATELY INFORMED THE CIRCUIT NURSE. THE TWO NURSES CONFIRMED AND KEPT THE CERTIFICATE AND IMMEDIATELY INFORMED THE RADIOLOGY DEPARTMENT TO TAKE THE EMERGENCY X-RAY. AFTER TAKING THE FILM, THE RADIOLOGIST FOUND A BRIGHT SPOT NEAR THE LEFT ILIAC FOSSA, WHICH WAS SUSPECTED TO BE NEEDLE TIP RESIDUE. AFTER THAT, THE SURGEON SEARCHED AND WASHED THE ABDOMINAL CAVITY UNDER THE DIRECT VISION OF LAPAROSCOPY. TOOK ANOTHER FILM AND FOUND THAT THERE WERE STILL BRIGHT SPOTS IN THE SIMILAR POSITION NEAR THE LEFT ILIAC FOSSA. THE RADIOLOGIST SUGGESTED TO CHANGE THE BODY POSITION, MOVED THE POSITION OF THE TOWEL, AND THEN TOOK THE FILM AGAIN IN THE SAME POSITION BUT STILL EXISTED HIGHLIGHTS. RADIOLOGISTS WAS NOT SURE IF IT WAS THE NEEDLE RESIDUE OR BONE CALCIFICATION. ANOTHER SUTURE WAS USED TO COMPLETE THE CASE.

  Patient problems: Foreign Body In Patient; Radiation Exposure, Unintended

  MAUDE report 8756279 ↗

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