Polysorb CLT-250-MGRecalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10884521044555), received between Sep 24, 2018 and Sep 28, 2026 — classified as 3 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Break” (10 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50924118 ↗
• MalfunctionDec 10, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING SURGICAL INCISION CLOSURE, THE NEEDLE TIP WAS FOUND TO BE DAMAGED. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20893835 ↗
• MalfunctionAug 8, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY OF AN OPEN CAESAREAN SECTION, AFTER USING THE DEVICE, THE SURGEON PLACED THE DEVICE ON THE TABLE WHILE BEING CLAMPED BY NEEDLE HOLDER, BUT THE NEEDLE FLEW OFF. THE NEEDLE WAS FOUND IN THE SURGICAL FIELD SIDE POCKET. WHEN THE NEEDLE WAS PLACED BACK ON THE SHEET, A BROKEN NEEDLE TIP WAS SEEN ON THE SHEET. THE NEEDLE THAT FLEW OFF WAS CHECKED IF IT WAS BROKEN, AND IT WAS CONFIRMED THAT IT DID NOT BREAK. AN IMAGING TEST WAS DONE TO IDENTIFY THE LOCATION OF THE BROKEN NEEDLE. AFTER LOOKING AMONG THE OTHER DISCARDED NEEDLES, THE NEEDLE WITH A BROKEN TIP WAS FOUND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19944247 ↗
• InjuryAug 8, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY OF AN OPEN CAESAREAN SECTION, AFTER USING THE DEVICE, THE SURGEON PLACED THE DEVICE ON THE TABLE WHILE BEING CLAMPED BY NEEDLE HOLDER, BUT THE NEEDLE FLEW OFF. THE NEEDLE WAS FOUND IN THE SURGICAL FIELD SIDE POCKET. WHEN THE NEEDLE WAS PLACED BACK ON THE SHEET, A BROKEN NEEDLE TIP WAS SEEN ON THE SHEET. THE NEEDLE THAT FLEW OFF WAS CHECKED IF IT WAS BROKEN, AND IT WAS CONFIRMED THAT IT DID NOT BREAK. AN IMAGING TEST WAS DONE TO IDENTIFY THE LOCATION OF THE BROKEN NEEDLE. AFTER LOOKING AMONG THE OTHER DISCARDED NEEDLES, THE NEEDLE WITH A BROKEN TIP WAS FOUND.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 19939674 ↗
• MalfunctionDec 27, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC TOTAL HYSTERECTOMY, UPON VAGINAL STUMP SUTURING AFTER HYSTERECTOMY, THE NEEDLE BROKE. THE SURGEON USED ANOTHER SUTURE TO RESOLVE THE ISSUE. THERE WAS NO PATIENT 1Q1INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18406761 ↗
• MalfunctionNov 20, 2023Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, BOTH SUTURE PACKS, HAD SIX SUTURES IN EACH PACK. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18172254 ↗
• MalfunctionNov 20, 2023Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, BOTH SUTURE PACKS, HAD SIX SUTURES IN EACH PACK. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18172227 ↗
• MalfunctionMay 26, 2023Product Quality Problem; Manufacturing, Packaging or Shipping Problem; Product Quality Problem; Manufacturing, Packaging or Shipping Problem

  ACCORDING TO THE REPORTER, INTRAOPERATIVELY, WHILE ON CLOSED ABDOMEN, A FEW MINUTES AFTER OPENING THE PACKAGE, IT WAS FOUND THAT THE PRODUCT HAD SIX NEEDLES INSTEAD OF FIVE NEEDLES. IT WAS ALSO MENTIONED THAT IN THE PACKAGING, THE TWO NEEDLES OVERLAPPED IN ONE PLACE AND ONLY ONE MORE NEEDLE WAS COUNTED WHEN THE NEEDLE COUNT WAS COMPLETED. THE NEEDLE WAS THEN PUT ASIDE. A NEW PACK OF SUTURE WAS OPENED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

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

  MAUDE report 17010328 ↗
• InjuryDec 12, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROTOMY PROCEDURE, LIGATION WITH MYOMETRIAL SUTURE FOR CAESARIAN SECTION, WHILE MYOMETRIUM WAS BEING SUTURED VIA KNOTTED SUTURE, THE TIP OF THE NEEDLE BROKE WHEN THE NEEDLE WAS DETACHED DURING THE CAESARIAN SECTION MYOMETRIAL SUTURE. AN X-RAY WAS PERFORMED, AND THE NEEDLE WAS SEARCHED.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 15960449 ↗
• InjuryAug 11, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING A TOTAL KNEE ARTHROPLASTY (TKA), WHEN EMPLOYING A KNOTTED SUTURE TECHNIQUE AT CLOSURE FASCIAL SUTURE, THE NEEDLE OF THE DEVICE BROKE AND WAS SUCCESSFULLY RETRIEVED. AN X-RAY WAS PERFORMED AT THE END OF THE PROCEDURE.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 15214911 ↗
• MalfunctionJul 21, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING CLAVICLE FRACTURE SURGERY, AT THE TIME OF SEWING THE FASCIA DURING THE INCISION CLOSURE, THE NURSE DISCOVERED THE EVENT BEFORE PLACING IT ON THE INSTRUMENT TABLE. THE NEEDLE TIP WAS ON THE FLOOR BETWEEN THE INSTRUMENT TABLE AND THE OPERATION TABLE. IT WAS HIGHLY POSSIBLE THAT THE PRODUCT GOT BROKE AFTER THE TISSUE WAS SEWED, BUT NO ONE WAS AWARE OF THE MOMENT IT BROKE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15076207 ↗
• MalfunctionJun 28, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING AN OPEN ABDOMINAL SURGERY, WHILE EMPLOYING AN INTERRUPTED SUTURE TECHNIQUE IN THE SUTURE OF THE UTERINE WALL AT THE END OF PROCEDURE, THE NEEDLE OF THE DEVICE BROKE. TO RESOLVE THE ISSUE, A NEW DEVICE WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14847970 ↗
• MalfunctionJan 21, 2019Break; Break

  ACCORDING TO THE REPORTER, DURING A CESAREAN SECTION, WHILE THE DEVICE WAS BEING USED IN THE UTERINE WALL SUTURING, WHEN THE THREAD AND NEEDLE WERE PULLED OUT, THE NEEDLE TIP BROKE. A NEW DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 8265487 ↗
• MalfunctionSep 24, 2018Break; Product Quality Problem; Break; Product Quality Problem

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE SUTURE WAS DISCOLORED. ALSO, IT JUST BROKE EASILY JUST TOUCHED. THE EVENT OCCURRED DURING THE PROCEDURE, BUT THE PRODUCT WAS NOT USED FOR PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7903398 ↗

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