Polysorb CL-823Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10884521042155), received between Jul 14, 2017 and Jan 21, 2026 — classified as 1 injury, 13 malfunctions.

The most frequently reported specific device problem is “Unraveled Material” (5 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 21, 2026Unraveled Material

  IT WAS REPORTED THAT POSTOPERATIVELY OF A VETERINARY CASE, THE SUTURE LINE DID NOT HOLD ON THE 36 DEVICES IN THE BOX, WHICH WAS IDENTIFIED BY THE PRESENCE OF EVENTRATION. ADDITIONAL SURGERY WAS REQUIRED TO RESOLVE THE ISSUE.

  Patient problems: Tissue Breakdown

  MAUDE report 24130704 ↗
• MalfunctionJun 5, 2025Break; Break

  IT WAS REPORTED ON A VETERINARY CASE, THAT THE WIRE DID NOT RESIST TENSION AND BROKE.

  Patient problems: Insufficient Information

  MAUDE report 22154631 ↗
• InjuryMar 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE VETERINARY OPERATION ON (B)(6) 2025 TO REMOVE A MASS, TWO SUTURES WERE USED FOR SUBCUTANEOUS CLOSURE. POST-OPERATIVE CONTROL REVEALED WOUND DEHISCENCE, INFECTION, AND WOUND HEALING DELAYS, NECESSITATING A REOPERATION ON JANUARY 29TH DUE TO COMPLICATIONS. AFTER SEVERAL CONTROLS AND MEDICATION, THE PATIENT EVENTUALLY HEALED, AND THE WOUND CLOSED.

  Patient problems: Impaired Healing; Unspecified Infection; Wound Dehiscence

  MAUDE report 21661114 ↗
• MalfunctionOct 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, POST OPERATIVE A VETERINARY CASE, WOUND DEHISCENCE HAS BEEN OBSERVED ON CANINE PATIENTS. THE PATIENTS WERE EXTERNALLY STAPLED TO RESOLVE THE ISSUE.

  Patient problems: Wound Dehiscence

  MAUDE report 20461225 ↗
• MalfunctionOct 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, POST OPERATIVE A VETERINARY CASE, WOUND DEHISCENCE HAS BEEN OBSERVED ON CANINE PATIENTS. THE PATIENTS WERE EXTERNALLY STAPLED TO RESOLVE THE ISSUE.

  Patient problems: Wound Dehiscence

  MAUDE report 20408966 ↗
• MalfunctionOct 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, POST OPERATIVE A VETERINARY CASE, WOUND DEHISCENCE HAS BEEN OBSERVED ON CANINE PATIENTS.

  Patient problems: Wound Dehiscence

  MAUDE report 20407267 ↗
• MalfunctionMar 31, 2023Unraveled Material; Unraveled Material

  ACCORDING TO THE REPORTER, 55 DAYS POST OPERATIVE OF AN OPEN CASTRATION VETERINARY PROCEDURE, IT WAS NOTICED THAT THERE WERE SOME REDNESS AND THERE WERE 2 OPENINGS AND SOME SERIOUS DISCHARGE. TO RESOLVE THE ISSUE, THE PATIENT WAS GIVEN ANTIBIOTICS AND COLD LASER THERAPY.

  Patient problems: Erythema; Fluid Discharge

  MAUDE report 16659309 ↗
• MalfunctionMar 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, 19 DAYS POST-OPERATIVELY OF A VETERINARY OVARIOHYSTERECTOMY (OHE), THE CANINE PATIENT WAS OBSERVED WITH REDNESS AND HAD DISCHARGE. DURING THE PROCEDURE, THE ABDOMINAL WALL WAS CLOSED USING A SUTURE IN A SIMPLE CONTINUOUS PATTERN, FOLLOWED WITH A SECOND LAYER OF SIMPLE INTERRUPTED SUTURES USING THE SAME MATERIAL AND INCLUDING THE SUBCUTANEOUS TISSUE. THE SKIN WAS CLOSED USING A SUTURE IN A SIMPLE CONTINUOUS SUBCUTICULAR PATTERN. TISSUE GLUE WAS USED OVER THE KNOTS. TWO DAYS FOLLOWING THE PROCEDURE, THE PATIENT WAS SEEN FOR MEDICAL INTERVENTION. THE PATIENT WAS GIVEN ANTIBIOTICS AND COLD LASER THERAPY TO RESOLVE THE ISSUE.

  Patient problems: Erythema; Fluid Discharge

  MAUDE report 16659245 ↗
• MalfunctionJan 6, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  ACCORDING TO THE REPORTER ON POST VETERINARY PROCEDURE, THE SUTURE WAS USED ON A CAT SPAY (STERILIZATION), AND THE VETERINARIAN REPORT SOME REACTIONS TO THE STRAND.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 13177747 ↗
• MalfunctionApr 19, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, SEVERAL DAYS POST-OPERATIVE OF A SPAY PROCEDURE, THE INCISION GOT RED AND RAISED. THE SUTURE WAS REPLACED WITH STAPLES AND THE PATIENT WAS GIVEN ANTIBIOTICS.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8533621 ↗
• MalfunctionApr 18, 2019Unraveled Material; Patient-Device Incompatibility; Unraveled Material; Patient-Device Incompatibility

  ACCORDING TO THE REPORTER, POST-OPERATIVE A NEUTER AND DECLAW PROCEDURE, THE PATIENT CAME BACK WITH RED AND INFLAMED SKIN AT THE SURGICAL SITE, THE SUTURE FELL APART WHEN TOUCHED. THE SURGEON REMOVED THE SUTURE FROM THE RIGHT DECLAW SURGERY, CLEANED THE WOUND AND CLOSED IT AGAIN BY STAPLING.

  Patient problems: No Code Available

  MAUDE report 8529691 ↗
• MalfunctionApr 18, 2019Unraveled Material; Unraveled Material

  ACCORDING TO THE REPORTER, THREE DAYS POST-OPERATIVE A MASS CELL TUMOR REMOVAL, THE PATIENT CAME BACK WITH OOZING FLUID ON THE SITE AND TWO DAYS AFTER, THE SUTURES LOOSENED AND THE CLOSURE OPENED. ANOTHER SURGERY REQUIRING ANESTHESIA WAS DONE AND THE SURGICAL TIME WAS EXTENDED BY 30 MINS. THE EVENT LEAD TO AN EXTENDED HOSPITAL STAY OF ONE DAY AND THE SUTURE LINE WAS RESUTURED.

  Patient problems: No Code Available

  MAUDE report 8529649 ↗
• MalfunctionSep 28, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, POST OPERATIVELY, THERE WAS MORE OFTEN INTOLERANCE REACTIONS APPEARED WITH FORMATION OF SUBCUTANEOUS FISTULAS. ONE CLOSED BLISTER OF A DOG SHOWED 8 DAYS AFTER SURGERY WOUND DEHISCENCE OVER MORE THAN 1 CM WITH URINE RUN-OFF INTO THE ABDOMINAL CAVITY. SUTURE WAS USED FOR SEVERAL LAPAROTOMIES AND OFTEN REACTIONS AND FISTULA FORMATION APPEARED. VET HAD NO PROBLEMS OF THIS KIND WITH OTHER SUTURES.

  Patient problems: Fistula; Wound Dehiscence

  MAUDE report 6900419 ↗
• MalfunctionJul 14, 2017Unraveled Material; Unraveled Material

  ACCORDING TO THE REPORTER, POST-OPERATIVELY, A CANINE PATIENT HAD A MIDLINE INCISION FOR A OVARIOHYSTERECTOMY. A SIMPLE CONTINUOUS SUTURE OF THE POLYSORB WAS PLACED IN THE MUSCLE AND SUB-CUTANEOUS THEN SUPRAMID IN THE SKIN. SHE WAS CHECKED ON THE (B)(6) AND EVERYTHING WAS FINE. ON THE (B)(6), SHE CAME BACK AND THE BREAKDOWN WAS FOUND. THE WOUND WOULD HAVE BEEN 7-10CM LONG. OWNERS INSISTED THAT THE DOG WAS RESTED AT HOME POST-SURGERY. PATIENT HAD TO BE RE-STITCHED, THUS INCURRING FURTHER COSTS FOR DRUGS, CONSUMABLES, THEATRE TIME AND AFTERCARE - OWNERS HAVE ASKED IF MEDTRONIC WOULD BE WILLING TO PAY FOR THE ADDITIONAL COSTS INCURRED.

  Patient problems: Injury

  MAUDE report 6715943 ↗

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