Polysorb CL-914Recalls & reported problems

Summary

The FDA's MAUDE database contains 138 adverse event reports that list this exact device (DI 10884521043329), received between Jul 18, 2017 and Sep 24, 2026 — classified as 13 injuries, 125 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (98 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 138 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2026Detachment of Device or Device Component

  It was reported that during the first stitch of continuous suturing in an open cesarean section, the suture was pulled with a needle holder to pass through tissue, and the needle detached on eleven sutures that were used. The affected sutures were replaced with another manufacturer¿s product to complete the procedure.

  Patient problems: Insufficient Information

  MAUDE report 50877117 ↗
• MalfunctionSep 24, 2026Detachment of Device or Device Component

  It was reported that during the first stitch of continuous suturing in an open cesarean section, the suture was pulled with a needle holder to pass through tissue, and the needle detached on eleven sutures that were used. The affected sutures were replaced with another manufacturer¿s product to complete the procedure.

  Patient problems: Insufficient Information

  MAUDE report 50877112 ↗
• MalfunctionSep 21, 2026Detachment of Device or Device Component

  According to the reporter, during the cesarian section procedure, the needle detached. A new suture was used to resolve the issue. There was no patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50836137 ↗
• MalfunctionSep 19, 2026Detachment of Device or Device Component

  Patient problems: Insufficient Information

  MAUDE report 50831658 ↗
• MalfunctionSep 19, 2026Detachment of Device or Device Component

  Patient problems: Insufficient Information

  MAUDE report 50831657 ↗
• MalfunctionSep 17, 2026Detachment of Device or Device Component

  Patient problems: Insufficient Information

  MAUDE report 50812363 ↗
• MalfunctionSep 17, 2026Detachment of Device or Device Component

  Patient problems: Insufficient Information

  MAUDE report 50810115 ↗
• MalfunctionSep 17, 2026Detachment of Device or Device Component

  It was reported that during the first stitch of continuous suturing in an open cesarean section, the suture was pulled with a needle holder to pass through tissue, and the needle detached on eleven sutures that were used. The affected sutures were replaced with another manufacturer¿s product to complete the procedure.

  Patient problems: Insufficient Information

  MAUDE report 50808511 ↗
• MalfunctionSep 17, 2026Detachment of Device or Device Component

  It was reported that during the first stitch of continuous suturing in an open cesarean section, the suture was pulled with a needle holder to pass through tissue, and the needle detached on eleven sutures that were used. The affected sutures were replaced with another manufacturer¿s product to complete the procedure.

  Patient problems: Insufficient Information

  MAUDE report 50806138 ↗
• MalfunctionSep 17, 2026Detachment of Device or Device Component

  Patient problems: Insufficient Information

  MAUDE report 50805935 ↗
• MalfunctionSep 17, 2026Detachment of Device or Device Component

  It was reported that during the first stitch of continuous suturing in an open cesarean section, the suture was pulled with a needle holder to pass through tissue, and the needle detached on eleven sutures that were used. The affected sutures were replaced with another manufacturer¿s product to complete the procedure.

  Patient problems: Insufficient Information

  MAUDE report 50804929 ↗
• MalfunctionSep 17, 2026Detachment of Device or Device Component

  It was reported that during the first stitch of continuous suturing in an open cesarean section, the suture was pulled with a needle holder to pass through tissue, and the needle detached on eleven sutures that were used. The affected sutures were replaced with another manufacturer¿s product to complete the procedure.

  Patient problems: Insufficient Information

  MAUDE report 50803284 ↗
• MalfunctionJun 8, 2026Break

  ACCORDING TO THE REPORTER, DURING A TOTAL HIP ARTHROPLASTY, WHEN THE SCRUB NURSE OPENED THE PACKAGE AND PREPARED TO GRASP THE SUTURE, IT WAS FOUND THAT THE NEEDLE HAD SEPARATED FROM THE SUTURE. AFTER REPLACING THE SUTURE NEEDLE, THE SUTURE BROKE AGAIN HALFWAY THROUGH SUTURING. AFTER REPLACING THE SUTURE NEEDLE ONCE MORE, IT BROKE AGAIN.

  Patient problems: Insufficient Information

  MAUDE report 25428871 ↗
• MalfunctionJun 8, 2026Break

  ACCORDING TO THE REPORTER, DURING A TOTAL HIP ARTHROPLASTY, WHEN THE SCRUB NURSE OPENED THE PACKAGE AND PREPARED TO GRASP THE SUTURE, IT WAS FOUND THAT THE NEEDLE HAD SEPARATED FROM THE SUTURE. AFTER REPLACING THE SUTURE NEEDLE, THE SUTURE BROKE AGAIN HALFWAY THROUGH SUTURING. AFTER REPLACING THE SUTURE NEEDLE ONCE MORE, IT BROKE AGAIN.

  Patient problems: Insufficient Information

  MAUDE report 25428779 ↗
• MalfunctionMar 13, 2026Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN OPEN ROBOTIC LAPAROSCOPIC SURGERY, ON THE UTERUS, THE CONNECTION BETWEEN THE NEEDLE AND THE THREAD WAS BROKEN AFTER SUTURING. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24592605 ↗
• MalfunctionMar 12, 2026Break

  IT WAS REPORTED THAT DURING AN OBSTETRIC PROCEDURE, AFTER CLOSING THE UTERINE SEROSAL LAYER, THE SUTURE SUDDENLY BROKE IN THE MIDDLE. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24584235 ↗
• InjuryJan 26, 2026Break

  ACCORDING TO THE REPORTER, DURING A CAESARIAN SECTION PROCEDURE, AFTER THE DELIVERY OF THE FETUS AND THE REMOVAL OF THE PLACENTA, THE PRIMARY SURGEON USED SUTURE TO PERFORM CONTINUOUS CLOSURE OF THE ABDOMINAL FASCIA. AFTER PROPERLY TYING AND SECURING THE SUTURE, THE SWAGE END OF THE SUTURE SUDDENLY BROKE WHILE CONTINUING CLOSURE, CAUSING THE PREVIOUSLY CLOSED FASCIA TO LOOSEN. THERE WAS SLIGHT TISSUE BULGING AT THE INCISION, AND A SMALL AMOUNT OF OOZING. THE PHYSICIAN IMMEDIATELY STOPPED THE PROCEDURE TO ASSESS THE SITUATION. THE TEAM REPLACED THE SUTURE WITH ANOTHER MODEL AND CONTINUED THE CLOSURE. THE BLEEDING WAS CONTROLLED BY COMPRESSION. THE OPERATION TIME WAS PROLONGED BY 30 MINUTES, BUT THE PATIENT RECOVERED WELL POSTOPERATIVELY AND WAS DISCHARGED ONLY ONE DAY LATER THAN PLANNED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Tissue Breakdown

  MAUDE report 24175933 ↗
• MalfunctionDec 16, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A CESAREAN SECTION PROCEDURE, AFTER COMPLETING THE UTERINE SUTURING, WHEN THE NEEDLE WAS BEING SET ASIDE, IT WAS FOUND THAT THE NEEDLE AND THREAD CONNECTION BROKE. THE SCRUB NURSE THEN PREPARED A NEW NEEDLE AND SUTURE TO CONTINUE WITH THE SUBSEQUENT TISSUE SUTURING. IT WAS NOTED THAT THE TIME WAS EXTENDED BY LESS THAN 30 MINUTES. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23822444 ↗
• MalfunctionNov 19, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A C-SECTION, THE CONNECTION ON THE NEEDLE AND THREAD BROKE WHILE SUTURING. IT WAS NOTED THAT THREE SUTURES FROM THE SAME PRODUCT AND LOT NUMBER WAS INVOLVED IN THE SAME EVENT WITH THE SAME PATIENT AND THAT THE SURGICAL TIME WAS EXTENDED. A NEW DEVICE FROM ANOTHER MANUFACTURER WAS USED TO RESOLVE THE ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23591077 ↗
• MalfunctionNov 18, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A C-SECTION, THE CONNECTION ON THE NEEDLE AND THREAD BROKE WHILE SUTURING. IT WAS NOTED THAT THREE SUTURES FROM THE SAME PRODUCT AND LOT NUMBER WAS INVOLVED IN THE SAME EVENT WITH THE SAME PATIENT AND THAT THE SURGICAL TIME WAS EXTENDED. A NEW DEVICE FROM ANOTHER MANUFACTURER WAS USED TO RESOLVE THE ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23581486 ↗
• MalfunctionNov 18, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A C-SECTION, THE CONNECTION ON THE NEEDLE AND THREAD BROKE WHILE SUTURING. IT WAS NOTED THAT THREE SUTURES FROM THE SAME PRODUCT AND LOT NUMBER WAS INVOLVED IN THE SAME EVENT WITH THE SAME PATIENT AND THAT THE SURGICAL TIME WAS EXTENDED. A NEW DEVICE FROM ANOTHER MANUFACTURER WAS USED TO RESOLVE THE ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23581394 ↗
• InjuryOct 21, 2025Mechanical Problem; Patient-Device Incompatibility; Mechanical Problem; Patient-Device Incompatibility

  ACCORDING TO THE REPORTER DURING AN OPEN REDUCTION AND INTERNAL FIXATION OF A RIGHT TIBIAL FRACTURE AND RIGHT FIBULAR FRACTURE UNDER GENERAL ANESTHESIA, AFTER THE PLATE WAS IMPLANTED, 0 ABSORBABLE SYNTHETIC SURGICAL SUTURE WAS USED FOR INTERRUPTED, LAYERED CLOSURE OF THE SUBCUTANEOUS TISSUE AND DEEP FASCIA. ON THE SECOND DAY AFTER SURGERY, THE PATIENT BEGAN TO EXPERIENCE RECURRENT FEVER, WITH A MAXIMUM TEMPERATURE OF 38.5°C, ACCOMPANIED BY PALLOR AND LIQUID EXUDATION OF THE SKIN AROUND PART OF THE INCISION. SUBSEQUENT SKIN NECROSIS WAS OBSERVED AND LATER, SUTURE KNOTS WERE FOUND TO BE EXPELLED FROM THE SUBCUTANEOUS TISSUE DURING DRESSING CHANGES. TO RESOLVE THE ISSUE, THE PATIENT WAS TREATED WITH ANTI-INFLAMMATORY THERAPY AND ENHANCED WOUND CARE, WITH INFRARED IRRADIATION OF THE INCISION TO PROMOTE BLOOD CIRCULATION.

  Patient problems: Fever; Necrosis; Pallor; Purulent Discharge

  MAUDE report 23345647 ↗
• InjuryOct 20, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  ACCORDING TO THE REPORTER, THE PATIENT UNDERWENT OPEN REDUCTION AND INTERNAL FIXATION WITH A PLATE FOR A LEFT HUMERAL FRACTURE. AFTER THE PLATE WAS IMPLANTED, ABSORBABLE SYNTHETIC SURGICAL SUTURES WERE USED TO PERFORM LAYERED CLOSURE OF THE SUBCUTANEOUS TISSUE AND DEEP FASCIA. THE SURGERY WAS COMPLETED SUCCESSFULLY. ON THE SECOND DAY AFTER SURGERY, THE PATIENT BEGAN TO EXPERIENCE RECURRENT FEVER, REDNESS AND SWELLING OF THE SKIN AROUND THE INCISION, ELEVATED LOCAL SKIN TEMPERATURE, EXUDATION, AND SOME LIQUEFIED TISSUE OBSERVED AT THE SUTURE SITE AND DRAINAGE TUBE, AS WELL AS SIGNIFICANT LOCALIZED TENDERNESS. THE PATIENT WAS TREATED WITH ENHANCED WOUND DRESSING CHANGES AND INFRARED IRRADIATION OF THE INCISION.

  Patient problems: Fever; Inflammation; Necrosis; Purulent Discharge

  MAUDE report 23338567 ↗
• MalfunctionOct 15, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER DURING THE ORTHOPEDIC JOINT REPLACEMENT SURGERY, ABSORBABLE SUTURES WITH SIX NEEDLES AND THREADS DETACHED, LEADING TO THE FAILURE OF WOUND SUTURING. THIS REQUIRED A REPLACEMENT OF THE SUTURE FOR RE-STITCHING, WHICH RESULTED IN PROLONGED SURGERY TIME ADDED PAIN FOR THE PATIENT.

  Patient problems: Pain

  MAUDE report 23276367 ↗
• MalfunctionOct 15, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER DURING THE ORTHOPEDIC JOINT REPLACEMENT SURGERY, ABSORBABLE SUTURES WITH SIX NEEDLES AND THREADS DETACHED, LEADING TO THE FAILURE OF WOUND SUTURING. THIS REQUIRED A REPLACEMENT OF THE SUTURE FOR RE-STITCHING, WHICH RESULTED IN PROLONGED SURGERY TIME ADDED PAIN FOR THE PATIENT.

  Patient problems: Pain

  MAUDE report 23276329 ↗

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