Polysorb CL-811Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10884521041929), received between Aug 2, 2017 and Sep 17, 2025 — classified as 3 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (4 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjurySep 17, 2025Break; Break

  IT WAS REPORTED THAT THE PATIENT WHO HAD UNDERGONE VAGINAL WALL CORRECTION PROCEDURES WITH SUTURES RETURNED TO THE HOSPITAL POST-OPERATIVELY DUE TO BLEEDING. THE KNOT OF THE SUTURE REMAINED IN PLACE, BUT THE SUTURE ITSELF WAS BROKEN, WHICH CAUSED THE BLEEDING. THE PATIENT UNDERGONE A NEW SURGERY TO STOP THE BLEEDING. THE PATIENT REQUIRED HOSPITAL READMISSION FOR THIS ISSUE.

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

  MAUDE report 23077021 ↗
• InjuryAug 8, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  ACCORDING TO THE REPORTER, 282 DAYS AFTER THE INITIAL PROCEDURE, WHILE PERFORMING AN OPEN CYSTOSCOPY, THE SURGEON NOTICED THAT THE SUTURE WAS COMPLETELY CALCIFIED. THIS ISSUE OCCURRED ON THREE DEVICES. IT WAS NOTED THAT THE PATIENT MUST UNDERGO SURGERY AGAIN.

  Patient problems: Calcium Deposits/Calcification; Foreign Body Reaction

  MAUDE report 19942884 ↗
• MalfunctionFeb 6, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, MULTIPLE SUTURE NEEDLES POPPED OFF THE SUTURE STRAND. IT WAS SIMILAR TO A POP-OFF SUTURE BUT THIS SUTURE IS A NOT A POP-OFF. A DIFFERENT BOX FROM A DIFFERENT LOT NUMBER WAS USED TO RESOLVE THE ISSUE.

  Patient problems: Insufficient Information

  MAUDE report 16305221 ↗
• MalfunctionMar 27, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC COLECTOMY, THE PRODUCT WAS TAKEN OUT OF THE PACKAGE BUT THE NEEDLE AND THE THREAD CAME OFF. THE PRODUCT WAS NOT USED ON THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9888905 ↗
• MalfunctionMar 1, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE NEEDLE WAS PENETRATED FROM THE TISSUE AND THE OPERATOR PULLED THE NEEDLE WITH A NEEDLE HOLDER, WHEN SUDDENLY THE NEEDLE WAS DETACHED FROM THE SWAGE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9772712 ↗
• InjuryJul 11, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, 4 TO 5 WEEKS FOLLOWING A FASCIA CLOSURE AT THE END OF THE HIP REPLACEMENT PROCEDURE, THE PATIENT NOTICED SWELLING AND OOZING OF THE WOUND, CAME BACK WITH SUTURE GRANULOMA ON DISTAL ENDS OF SUBCUTANEOUS SUTURE. THE PATIENT WAS GIVEN ANTIBIOTICS, HAD REVISIONAL OPERATION AND WOUND HEALING THEREAFTER. THIS RESULTED TO EXTENDED PATIENT HOSPITALIZATION.

  Patient problems: Granuloma; No Code Available; Tissue Damage

  MAUDE report 8780730 ↗
• MalfunctionJul 31, 2018Break

  ACCORDING TO THE REPORTER, DURING THE CLOSURE OF A CAESAREAN SECTION, THE NEEDLE BROKE. A NEW SUTURE WAS OPENED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

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

  MAUDE report 7736045 ↗
• MalfunctionAug 2, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING USE, THE NEEDLE DETACHED FROM SUTURE. NO PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6760938 ↗

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