Polysorb SL-632Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10884521048966), received between Oct 14, 2024 and Apr 17, 2025 — classified as 8 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. 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.

• MalfunctionApr 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER AN OVARIECTOMY ON A CAT, THE SUTURE LINE DID NOT HOLD, RESULTING IN AN OPEN ABDOMEN. THE ISSUE WAS IDENTIFIED 4 DAYS POST-OPERATION, NECESSITATING THE CAT'S RE-ADMISSION AND RE-OPERATION. THE RE-OPERATION WAS PERFORMED USING THE SAME SUTURE. SINCE THE REOPERATION, THE PATIENT IS FINE AND NO OTHER ADVERSE EVENTS HAVE BEEN DECLARED.

  Patient problems: Tissue Breakdown

  MAUDE report 21853100 ↗
• MalfunctionOct 30, 2024Unraveled Material; Unraveled Material

  ACCORDING TO THE REPORTER, POSTOPERATIVE OVARIECTOMY VETERINARY (VET), FOUR DAYS AFTER PROCEDURE, THE SUTURE LINE DID NOT HOLD, THE PATIENT WAS READMITTED AND RE-OPERATED. TO RESOLVE THE ISSUE, OPENING OF THE LINEA ALBA, OVARIECTOMY THEN ABDOMINAL WALL CLOSURE WITH CONTINUOUS SUTURING.

  Patient problems: Tissue Breakdown

  MAUDE report 20571276 ↗
• MalfunctionOct 29, 2024Unraveled Material; Unraveled Material

  ACCORDING TO THE REPORTER, ON POST OPERATIVE OVARIECTOMY OF A VETERINARY CASE, FOUR DAYS AFTER THE PROCEDURE, THE SUTURE DID NOT HOLD. THE PATIENT CAME BACK WITH ABDOMINAL INCISIONAL HERNIA ON THE SUTURE LINE. THE PATIENT HAD TO BE READMITTED AND RE-OPERATED BY OPENING OF THE LINEA ALBA, OVARIECTOMY THEN ABDOMINAL WALL CLOSURE WITH CONTINUOUS SUTURE STITCHES.

  Patient problems: Hernia; Tissue Breakdown

  MAUDE report 20559054 ↗
• MalfunctionOct 25, 2024Unraveled Material; Unraveled Material

  ACCORDING TO THE REPORTER, POST-OPERATIVELY OF A VETERINARIAN CASE, THE DOG WAS OPERATED FOR AN OVARIECTOMY. THE DOG CAME BACK AFTER 3 DAYS WITH EVISCERATION AT THE SUTURE LINE AND THE SUTURE LINE DID NOT HOLD SO HAD TO BE READMITTED AND RE-OPERATED.

  Patient problems: Tissue Breakdown; Wound Dehiscence

  MAUDE report 20537054 ↗
• MalfunctionOct 25, 2024Unraveled Material; Unraveled Material

  ACCORDING TO THE REPORTER, POST-OPERATIVELY OF A VETERINARIAN CASE, THE CAT WAS OPERATED FOR AN OVARIECTOMY. THE CAT CAME BACK AFTER 5 DAYS WITH ABDOMINAL/INCISIONAL HERNIA AT THE SUTURE LINE AND THE SUTURE LINE DID NOT HOLD SO THE CAT HAD TO BE READMITTED AND RE-OPERATED.

  Patient problems: Hernia; Tissue Breakdown

  MAUDE report 20534521 ↗
• MalfunctionOct 24, 2024Unraveled Material; Unraveled Material

  ACCORDING TO THE REPORTER, 3 DAYS POST-OPERATIVELY IN A VETERINARIAN CASE, THE CAT WAS OPERATED ON FOR AN OVARIO-HYSTERECTOMY. THE CAT CAME BACK AFTER 3 DAYS WITH EVISCERATION AT THE SUTURE LINE, AND THE SUTURE LINE DID NOT HOLD. THE PATIENT WAS READMITTED AND HAD TO BE RE-OPERATED FOR ABDOMINAL/INCISIONAL HERNIA ON THE SUTURE LINE.

  Patient problems: Hernia; Tissue Breakdown

  MAUDE report 20526116 ↗
• MalfunctionOct 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, SIX DAYS AFTER AN OVARIECTOMY (VETERINARY PROCEDURE), THE PATIENT CAME BACK WITH SEVEN ABDOMINAL INCISIONAL HERNIA AT THE SUTURE LINE. THE PATIENT WAS READMITTED AND REOPERATED TO RESOLVE THE ISSUE.

  Patient problems: Hernia

  MAUDE report 20463138 ↗
• MalfunctionOct 14, 2024Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  ACCORDING TO THE REPORTER, TWO NEEDLE SUTURES WERE INSERTED INTO ONE PACKET. THE USER OPENED A NEW PACKET TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20438898 ↗

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