Polysorb CL-977Recalls & reported problems

Summary

The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 10884521044241), received between Jan 22, 2018 and Sep 30, 2026 — classified as 24 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (17 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 25 most recent of 37 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50951891 ↗
• MalfunctionSep 29, 2026Break

  Patient problems: Insufficient Information

  MAUDE report 50937404 ↗
• MalfunctionMar 31, 2026Break

  IT WAS REPORTED THAT DURING A REPEAT CESAREAN SECTION VIA A LOWER UTERINE SEGMENT TRANSVERSE INCISION, WHEN THE SURGEON WAS SUTURING THE FAT LAYER, THE NEEDLE SUDDENLY BROKE. THE PROCEDURE WAS IMMEDIATELY PAUSED TO LOCATE THE BROKEN NEEDLE, WHICH WAS EVENTUALLY FOUND BENEATH THE FAT LAYER. THE SURGERY THEN CONTINUED AS PLANNED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24742800 ↗
• MalfunctionJul 29, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER DURING A PROCEDURE, WHILE SUTURING AND PULLING THE SURGEON'S STRENGTH WAS NOT CONTROLLED ENOUGH. THE CONNECTION BETWEEN THE NEEDLE AND THREAD DETACHED. TO RESOLVE THE ISSUE A NEW DEVICE WAS USED. IT WAS NOTED THAT THE SURGICAL TIME WAS EXTENDED.

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

  MAUDE report 22641768 ↗
• MalfunctionMar 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, THE PATIENT UNDERWENT SURGERY ON (B)(6) 2025. SYNTHETIC ABSORBABLE SURGICAL SUTURE WAS USED FOR SUBCUTANEOUS SUTURE DURING THE SURGERY, AND SUTURED TIGHTLY DURING THE SURGERY. POOR INCISION HEALING AND INCISION EXUDATION WERE FOUND POSTOPERATIVELY ON (B)(6) 2025, ALSO, THE PATIENT HAD INCISION PAIN. AFTERWARDS, PART SUTURE WAS REMOVED AND THE DRESSING WAS CHANGED ACCORDING TO THE SYMPTOMS. AFTER TREATMENT, THE PATIENT'S WOUND RECOVERED WELL.

  Patient problems: Fluid Discharge; Pain

  MAUDE report 21695234 ↗
• MalfunctionFeb 6, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  ACCORDING TO THE REPORTER, SIX DAYS FOLLOWING A PROCEDURE, WHEREIN THE SUTURE WAS USED TO ANASTOMOSE THE SUBCUTANEOUS TISSUE, THE PATIENT¿S WOUND WAS FOUND TO BE EXUDING. THE SUTURE WAS DISINFECTED AND REMOVED. AFTER THE REMOVAL, THE SUTURE WAS FOUND TO HAVE A SUTURE REACTING, CAUSING DELAYED WOUND HEALING. THE PATIENT WAS ADVISED TO PROTECT THE WOUND FROM INFECTION AND STRENGTHEN CARE.

  Patient problems: Fluid Discharge

  MAUDE report 21324851 ↗
• InjuryFeb 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING AN OPEN REDUCTION OF A RIGHT INTERTROCHANTERIC FRACTURE AND PROXIMAL FEMORAL LOCKING PLATE INTERNAL FIXATION, THE DEVICE WAS USED TO SUTURE THE MUSCLES AND SUBCUTANEOUS TISSUES. HOWEVER, FIVE DAYS LATER, THE SURGICAL WOUND HEALED POORLY, WITH A LITTLE YELLOW CLEAR EXUDATE AND OBVIOUS PURULENT SECRETIONS. THE EXUDATE WAS TAKEN FOR BACTERIAL CULTURE ON (B)(6), AND THE RESULTS WERE NEGATIVE. SOME SYNTHETIC ABSORBABLE SURGICAL SUTURES WERE REMOVED. THE SURGEON STRENGTHENED THE DRESSING CHANGE OF THE SURGICAL WOUND, CEFAZOLIN SODIUM, TO PREVENT INFECTION, AND OTHER SYMPTOMATIC TREATMENTS WERE DONE TO RESOLVE THE ISSUE.

  Patient problems: Foreign Body Reaction; Impaired Healing

  MAUDE report 21298462 ↗
• MalfunctionNov 16, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  ACCORDING TO THE REPORTER, POSTOPERATIVE TO OPEN REDUCTION AND KIRSCHNER WIRE TENSION BAND INTERNAL FIXATION OF THE LEFT GREATER TROCHANTER AVULSION FRACTURE, THE PATIENT DEVELOPED FEVER. THE PHYSICAL EXAMINATION SHOWED THAT THE SOFT TISSUE AROUND THE INCISION WAS SLIGHTLY RED AND SWOLLEN. THE BODY TEMPERATURE DROPPED AFTER TREATMENT.

  Patient problems: Fever

  MAUDE report 18152698 ↗
• InjuryDec 14, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  ACCORDING TO THE REPORTER, ON POST OPERATIVE, THE PATIENT GAVE BIRTH AND UNDERWENT SUTURE OF FIRST DEGREE LACERATION OF PERINEUM. LESS THAN TWO WEEKS AFTER, THE PATIENT COMPLAINED OF PAIN AND DISCOMFORT OF PERINEUM WOUND. IT WAS CHECKED AND FOUND THAT THE SKIN LAYER OF PERINEUM WOUND OF THE PATIENT WAS CRACKED, AND THE SUTURES WERE NOT ABSORBED RESULTING TO POOR WOUND HEALING. THE SUTURES WERE REMOVED FROM THE WOUND, AND THE PATIENT WAS OBSERVED BY FUMIGATION AND WASHING WITH CHINESE MEDICINE.

  Patient problems: Impaired Healing; Pain; Unspecified Tissue Injury

  MAUDE report 15979137 ↗
• InjuryDec 10, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  ACCORDING TO THE REPORTER, AFTER A LATERAL EPISIOTOMY, THE PATIENT COMPLAINED OF UNBEARABLE PAIN AND DEHISCENCE OF THE PERINEAL WOUND. WHEN THE PERINEAL WOUND DEHISCENCE WAS CHECKED, THE SUTURE WAS NOT ABSORBED AT ALL. THE TENSION OF THE SUTURE WAS STRONG AND THERE WAS NO SIGN OF ABSORPTION. THE SUTURE WAS REMOVED, THE PATIENT'S SYMPTOMS WERE RELIVED AND THE WOUND HEALED. MANY PATIENTS SUFFERED FROM MALABSORPTION OF SUTURES AT THE SAME TIME.

  Patient problems: Pain; Wound Dehiscence

  MAUDE report 15955992 ↗
• InjuryDec 9, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  ACCORDING TO THE REPORTER, AFTER A LATERAL EPISIOTOMY, THE PATIENT COMPLAINED OF UNBEARABLE PAIN AND DEHISCENCE OF THE PERINEAL WOUND. WHEN THE PERINEAL WOUND DEHISCENCE WAS CHECKED, THE SUTURE WAS NOT ABSORBED AT ALL. THE TENSION OF THE SUTURE WAS STRONG AND THERE WAS NO SIGN OF ABSORPTION. THE SUTURE WAS REMOVED, THE PATIENT'S SYMPTOMS WERE RELIVED AND THE WOUND HEALED. MANY PATIENTS SUFFERED FROM MALABSORPTION OF SUTURES AT THE SAME TIME.

  Patient problems: Pain; Wound Dehiscence

  MAUDE report 15951732 ↗
• InjuryDec 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, NINE DAYS POSTOPERATIVE TO LATERAL EPISIOTOMY, THE PATIENT COMPLAINED OF PAIN AND DEHISCENCE OF THE PERINEAL WOUND. UPON CHECKING THE WOUND DEHISCENCE, THE SUTURE WAS NOT ABSORBED AT ALL AND THERE WAS POOR WOUND HEALING, NON-ABSORBING SUTURES. AFTER THE SUTURE WAS REMOVED, THE PATIENT'S SYMPTOMS WERE RELIEVED AND THE WOUND HEALED.

  Patient problems: Impaired Healing; Pain; Wound Dehiscence

  MAUDE report 15951430 ↗
• InjuryDec 9, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  ACCORDING TO THE REPORTER, ON POST OPERATIVELY, THE PERINEUM WAS LACERATED AND WAS SUTURED. LESS THAN TWO WEEKS AFTER THE PATIENT GAVE BIRTH, THE PATIENT INFORMED THAT THE WOUND ON THE PERINEUM WAS PAINFUL AND UNBEARABLE. THE WOUND DID NOT HEAL WELL AND THE SUTURE WAS NOT ABSORBED, WHICH CAUSED GREAT SUFFERING TO THE PATIENT. THE SUTURE WAS THEN REMOVED AND THE PATIENT'S SYMPTOMS WERE RELIEVED.

  Patient problems: Impaired Healing; Pain

  MAUDE report 15951315 ↗
• MalfunctionOct 3, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING A VAGINAL TOTAL HYSTERECTOMY, THE OPERATION WENT SMOOTHLY BUT IN SUTURING THE WOUND, THE SUTURE BROKE. TO CONTINUE, THE SUTURE WAS REPLACED WITH A NEW ONE. THE OPERATION TIME WAS PROLONGED WHICH INCREASED THE OPERATION RISK. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15528742 ↗
• InjurySep 6, 2022Break; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Break; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING AN OPEN LATERAL EPISIOTOMY, WHEN THE MUCOSA AND MUSCLE WAS SUTURED BY CONTINUOUS SUTURE TECHNIQUE, THE NEEDLE WAS BROKEN AND THE BROKEN NEEDLE COULD NOT BE FOUND. AFTER CUTTING ALL SUTURED WOUNDS, THE BROKEN NEEDLE WAS FOUND IN THE MUSCLE. NEW SUTURE WAS TAKEN AND THE TISSUE WAS RE-SUTURED. THIS RESULTED IN TISSUE DAMAGE. THE SURGICAL PROCEDURE WAS EXTENDED FOR MORE THAN THIRTY MINUTES.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 15366766 ↗
• InjuryDec 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, FOLLOWING A LAPAROSCOPIC INTESTINAL ADHESION LYSIS WITH LAPAROSCOPIC TUBAL PUNCTURE AND ASPIRATION PROCEDURE, A MEDICAL COMPLICATION WAS REPORTED. AFTER 37 DAYS FROM SURGERY FOR HER FOLLOW-UP VISIT, IT WAS CHECKED THAT THE UMBILICAL INCISION OF THE PATIENT WAS CRACKED AND EXUDATE. AFTER DEBRIDEMENT, OBVIOUS ABSORBABLE SUTURES WERE VISIBLE IN STRIPS AND UNABSORBED AND EXPOSED ON THE INCISION. TO RESOLVE THE ISSUE, THE DOCTOR DISINFECTED THE INCISION AND CUT OFF THE UNABSORBED SUTURES.

  Patient problems: Impaired Healing; Inflammation; Swelling/ Edema

  MAUDE report 13094916 ↗
• InjuryDec 28, 2021Patient-Device Incompatibility; Patient-Device Incompatibility

  ACCORDING TO THE REPORTER, THE PATIENT HAD A CAESAREAN SECTION OF THE LOWER UTERUS UNDER INTRA-SPINAL ANESTHESIA. THE INCISION WAS SUTURED LAYER BY LAYER WITH ABSORBABLE SUTURES, AND INTRADERMAL COSMETIC SUTURE. THE DRESSING WAS CHANGED EVERY OTHER DAY, AND AFTER 24 HOURS, THE FAR-INFRARED RADIATION TREATMENT WAS PERFORMED TWICE A DAY. PATIENT WAS CHECKED ON THE 10TH DAY POST-OPERATIVE AND GOT DISCHARGED AFTER. HOWEVER, AFTER 13 DAYS POST-OPERATIVELY, THE PATIENT RETURNED TO THE HOSPITAL. THE INCISION WAS CHECKED, AND THE LEFT SIDE HAD AN ABOUT 1 CENTIMETER DEHISCENCE. THE ABSORBABLE SUTURES WERE SHOWED AS STRIPS, UNABSORBED, AND EXPOSED. THE INCISION SITE WAS CLEANED, DISINFECTED, AND THE UNABSORBED SUTURES WERE CUT OFF. ON THE 17TH DAY, THE PATIENT HAD ANOTHER FOLLOW-UP AND THE INCISION WAS OBSERVED TO HEALED WELL.

  Patient problems: Wound Dehiscence

  MAUDE report 13093077 ↗
• InjuryDec 28, 2021Unraveled Material; Unraveled Material

  ACCORDING TO THE REPORTER, EIGHT DAYS FOLLOWING A CHILDBIRTH, WHEN THE PATIENT RETURNED FOR A FOLLOW-UP VISIT, THE INCISION WAS PARTIALLY CRACKED AND OBSERVED THAT THE SUTURES WERE IN STRIPS AND NOT ABSORBED. AFTER THREE DAYS, THE SURGEON CUT OFF THE UNABSORBED SUTURE AND DISINFECTED THE INCISION ON THE SECOND FOLLOW-UP VISIT TO RESOLVE THE ISSUE.

  Patient problems: Wound Dehiscence

  MAUDE report 13093029 ↗
• InjuryJul 27, 2021Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, THE DEVICE WAS USED TO REPAIR THE WOUND BUT THREE DAYS FOLLOWING A HERNIA REPAIR PROCEDURE, THE PATIENT EXPERIENCED REDNESS, SWELLING, HEAT, PAIN AND INFECTION. THE SURGEON IMMEDIATELY REMOVED THE SUTURES AND CHANGED THE DEPRESSING TREATMENT. AFTER THE SECOND STAGE SUTURE, THE PATIENT¿S CONDITION IMPROVED.

  Patient problems: Pain

  MAUDE report 12226544 ↗
• InjuryNov 10, 2020Unraveled Material; Unraveled Material

  ACCORDING TO THE REPORTER, AFTER GIVING BIRTH, THE PATIENT'S SIDE INCISION WAS SUTURED LAYER BY LAYER WITH ABSORBABLE SUTURES AND IN TRADERMAL SUTURES. DURING THE HOSPITALIZATION PERIOD, IT WAS DISINFECTED TWICE A DAY WITH IODOPHOR AND TREATED WITH FAR-INFRARED RADIATION TWICE A DAY. DURING THE PERIOD, THE PARTURIENT WOMAN COMPLAINED THAT THE WOUND HAD FOREIGN BODY SENSATION AND PAIN WAS TOLERABLE. ON (B)(6) 2020, IT WAS FOUND THAT THE LOWER END OF THE PERINEAL SIDE INCISION WAS SPLIT AND THERE WAS EXUDATION. IT WAS SEEN THAT THE ABSORBABLE SUTURES WERE EXPOSED IN STRIPS, THE KNOTS WERE PROMINENT, AND THE PERINEAL INCISIONS WERE NOT HEALED WELL. DEBRIDED THE NECROSIS ON THE SURFACE OF THE PERINEAL INCISION, REMOVED THE THREAD AND KNOTS AND STRENGTHEN THE PERINEAL CARE. THE MEDICAL INTERVENTION OF DEBRIDEMENT REQUIRED THE PATIENT TO UNDERGO AN ADDITIONAL SURGICAL PROCEDURE. THE PATIENT'S HOSPITALIZATION WAS EXTENDED AS A RESULT OF THE COMPLICATION. THE INCISION HEALED ON (B)(6) 2020.

  Patient problems: Foreign Body Sensation in Eye; Necrosis; No Code Available; Post Operative Wound Infection

  MAUDE report 10815401 ↗
• MalfunctionJul 17, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  ACCORDING TO THE REPORTER, AFTER RESECTION OF THE LEFT VESTIBULAR GLAND CYST, UPON CHECKING INCISION CRACKED AND THE OBVIOUS ABSORBABLE SUTURES WERE NOT ABSORBED IN STRIPS. THE SURGEON CLEANED AND DISINFECTED THE INCISION, CUT OFF THE UNABSORBED SUTURES. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10290803 ↗
• InjuryJul 7, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  ACCORDING TO THE REPORTER, POST OPERATIVELY ON A GYNECOLOGICAL PROCEDURE, THE SURGEON USED AN ABSORBABLE SUTURING DEVICE TO CLOSED THE WOUND AND WHILE THE PATIENT WAS RECOVERING THE WOUND WAS DISINFECTED TWICE A DAY WITH IODOPHOR AND TREATED TWICE A DAY WITH FAR INFRARED RADIATION, HOWEVER THE PATIENT COMPLAINT THAT THE WOUND HAD A FOREIGN BODY SENSATION ACCOMPANIED BY PAIN. UPON CHECKING ROUND OF PERINEAL WOUNDS WAS FOUND AND NECROSIS, EXUDATION, AND HEAVY ODOR WERE SEEN. THE ABSORBABLE SUTURES WERE EXPOSED IN STRIPS, AND THE PERINEAL WOUNDS WERE DIAGNOSED AS POORLY HEALED. TO RESOLVE THE ISSUE THE SURGEON HAD TO REMOVED THE UNABSORBED SUTURE THREAD AT THE PATIENT AND PERFORMED AN INTERVENTION TO USED A SECONDARY MEDICAL SILK TO PREPARE SUTURES.

  Patient problems: No Code Available; Pain; Unspecified Infection

  MAUDE report 10240570 ↗
• InjuryJun 19, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, THE PATIENT WAS HOSPITALIZED WITH RIGHT LOWER ABDOMINAL PAIN FOR 2 DAYS. THE ADMITTING DIAGNOSIS WAS ACUTE APPENDICITIS WITH PERITONITIS. THE PATIENT WAS SENT TO THE OPERATING ROOM FOR LAPAROSCOPIC EXPLORATION UNDER ANESTHESIA UNDER TRACHEAL INTUBATION, TRANSITIVE COLONIC BOWEL RESECTION AND SINGLE CAVITY OSTOMY. THE PROCEDURE WAS SMOOTH, AND THE INCISION WAS RED, SWOLLEN, PAINFUL, AND EXUDED. THE INCISION SITE WAS DEBRIDED AND RECLOSED. THEY GAVE CLEANED UNABSORBED THREAD, CLEANED THE INCISION, PROLONGED THE APPLICATION OF ANTIBIOTICS, INTRAVENOUS DRIP 0.9% NS100ML WITH CEFOPERAZONE SODIUM, TAZOBACTAM SODIUM 2.0G. THE INTRAVENOUS DRIP WAS GIVEN BUT THE ANTIBIOTICS APPLICATION WAS EXTENDED. THE DRESSING WAS CHANGED.

  Patient problems: Impaired Healing; No Code Available; Pain; Purulent Discharge; Swelling

  MAUDE report 10173425 ↗
• MalfunctionJun 11, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, WHEN THE UTERUS WAS SUTURED BY CESAREAN SECTION, THE SUTURE (DOUBLE NEEDLE) NEEDLE AND THREAD CONNECTION ACCIDENTALLY DETACHED, AND A NEW SUTURE OF THE SAME TYPE AND LOT NUMBER WAS OPENED, BUT IT OCCURRED AGAIN. THE SUTURE WAS REPLACED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10143537 ↗
• InjuryDec 10, 2019Unraveled Material; Patient-Device Incompatibility; Unraveled Material; Patient-Device Incompatibility

  ACCORDING TO THE REPORTER, THE PATIENT UNDERGO A TRANSABDOMINAL HYSTERECTOMY PROCEDURE, TO INTERMITTENTLY SUTURE THE FAT LAYER WITH SYNTHETIC ABSORBABLE SURGICAL SUTURES. THIRD DAY POST-OPERATIVELY, THE INCISION HAD A LITTLE EXUDATE, NO CHILLS, NO FEVER OR NO ABDOMINAL PAIN AND NO ABNORMALITIES WERE FOUND IN THE ROUTINE BLOOD TEST. BUT IT WAS REPORTED THAT THE ABSORPTION OF THE SUTURE WAS SLOWER LEADING TO POOR WOUND HEALING. AND ON SEVENTH DAY POST-OPERATIVELY THE INCISION WAS SPLIT ABOUT 8 CM DEEP TO REACH THE FAT LAYER, AND THE ABSORBABLE SUTURE COULD BE SEEN. TO RESOLVE THE ISSUE THE SUTURE IMMEDIATELY REMOVED AND HAD TO RE-SUTURE THE PATIENT. OTHER TREATMENT WAS TAKEN BY INTRAVENOUS INFUSION OF 0.9% SODIUM CHLORIDE INJECTION 100ML AND CEFOTIAM 2.0G TO PREVENT INFECTION. THE INCISION WAS GIVEN A SPECIFIC ELECTROMAGNETIC WAVE THERAPEUTIC DEVICE, AND THERMAL IRRADIATION AND ENHANCED DRESSING TREATMENT.

  Patient problems: No Code Available; Wound Dehiscence

  MAUDE report 9444329 ↗

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