Polysorb CL-802Recalls & reported problems

Summary

The FDA's MAUDE database contains 55 adverse event reports that list this exact device (DI 10884521041851), received between Jan 9, 2020 and Feb 18, 2026 — classified as 55 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (37 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 55 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 18, 2026Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING FASCIAL SUTURING AND CHEST CLOSURE, THE FIVE NEEDLES FREQUENTLY DETACHED DURING SUTURING. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24384681 ↗
• MalfunctionFeb 18, 2026Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING FASCIAL SUTURING AND CHEST CLOSURE, THE FIVE NEEDLES FREQUENTLY DETACHED DURING SUTURING. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24384529 ↗
• MalfunctionFeb 18, 2026Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING FASCIAL SUTURING AND CHEST CLOSURE, THE FIVE NEEDLES FREQUENTLY DETACHED DURING SUTURING. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24384498 ↗
• MalfunctionFeb 18, 2026Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING FASCIAL SUTURING AND CHEST CLOSURE, THE FIVE NEEDLES FREQUENTLY DETACHED DURING SUTURING. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24384456 ↗
• MalfunctionFeb 17, 2026Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING FASCIAL SUTURING AND CHEST CLOSURE, THE FIVE NEEDLES FREQUENTLY DETACHED DURING SUTURING. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24373598 ↗
• MalfunctionFeb 11, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PROCEDURE, WHILE SUTURING, THERE WERE TWO SUTURES HAD NEEDLE POPPING OFF. AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24314036 ↗
• MalfunctionFeb 11, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PROCEDURE, WHILE SUTURING, THERE WERE TWO SUTURES HAD NEEDLE POPPING OFF. AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24313916 ↗
• MalfunctionJan 21, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PROCEDURE, WHILE PREPARING PRIOR TO PATIENT INCISION, ON TWO DEVICES, THE NEEDLE BROKE OFF AT THE CONNECTION OF THE NEEDLE AND THREAD. THESE ISSUES OCCURRED WHILE REMOVING THE SUTURE FROM THE RETAINER. THE ISSUE WAS RESOLVED BY USING SUTURES FROM ANOTHER MANUFACTURER. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24137365 ↗
• MalfunctionJan 21, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PROCEDURE, WHILE PREPARING PRIOR TO PATIENT INCISION, ON TWO DEVICES, THE NEEDLE BROKE OFF AT THE CONNECTION OF THE NEEDLE AND THREAD. THESE ISSUES OCCURRED WHILE REMOVING THE SUTURE FROM THE RETAINER. THE ISSUE WAS RESOLVED BY USING SUTURES FROM ANOTHER MANUFACTURER. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24137178 ↗
• MalfunctionJan 14, 2026Break

  IT WAS REPORTED THAT DURING A PROCEDURE, 36 SUTURES WERE BROKEN. NO PATIENT SYMPTOMS, COMPLICATIONS, ADVERSE EVENTS, ILLNESSES, INFECTIONS, IRREGULARITIES, OR DEATHS WERE IDENTIFIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24065200 ↗
• MalfunctionNov 17, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN OPEN ORTHOPEDIC PROCEDURE, THE NEEDLES ON BOTH SUTURES DETACHED FROM THE SUTURE STRANDS WHILE SUTURING. THE NEEDLES DID NOT FALL INTO THE PATIENT CAVITY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23566404 ↗
• MalfunctionOct 27, 2025Break; Break

  IT WAS REPORTED THAT DURING AN OPEN C-SECTION PROCEDURE, THE 10 SUTURES BROKE WHILE SUTURING. THE SURGEON USED ANOTHER SUTURE TO RESOLVE THE ISSUE AND COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23391688 ↗
• MalfunctionOct 27, 2025Break; Break

  IT WAS REPORTED THAT DURING AN OPEN C-SECTION PROCEDURE, THE 10 SUTURES BROKE WHILE SUTURING. THE SURGEON USED ANOTHER SUTURE TO RESOLVE THE ISSUE AND COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23391669 ↗
• MalfunctionOct 27, 2025Break; Break

  IT WAS REPORTED THAT DURING AN OPEN C-SECTION PROCEDURE, THE 10 SUTURES BROKE WHILE SUTURING. THE SURGEON USED ANOTHER SUTURE TO RESOLVE THE ISSUE AND COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23390667 ↗
• MalfunctionOct 27, 2025Break; Break

  IT WAS REPORTED THAT DURING AN OPEN C-SECTION PROCEDURE, THE 10 SUTURES BROKE WHILE SUTURING. THE SURGEON USED ANOTHER SUTURE TO RESOLVE THE ISSUE AND COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23390584 ↗
• MalfunctionOct 27, 2025Break; Break

  IT WAS REPORTED THAT DURING AN OPEN C-SECTION PROCEDURE, THE 10 SUTURES BROKE WHILE SUTURING. THE SURGEON USED ANOTHER SUTURE TO RESOLVE THE ISSUE AND COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23390488 ↗
• MalfunctionOct 27, 2025Break; Break

  IT WAS REPORTED THAT DURING AN OPEN C-SECTION PROCEDURE, THE 10 SUTURES BROKE WHILE SUTURING. THE SURGEON USED ANOTHER SUTURE TO RESOLVE THE ISSUE AND COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23390408 ↗
• MalfunctionOct 27, 2025Break; Break

  IT WAS REPORTED THAT DURING AN OPEN C-SECTION PROCEDURE, THE 10 SUTURES BROKE WHILE SUTURING. THE SURGEON USED ANOTHER SUTURE TO RESOLVE THE ISSUE AND COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23390341 ↗
• MalfunctionOct 27, 2025Break; Break

  IT WAS REPORTED THAT DURING AN OPEN C-SECTION PROCEDURE, THE 10 SUTURES BROKE WHILE SUTURING. THE SURGEON USED ANOTHER SUTURE TO RESOLVE THE ISSUE AND COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23390213 ↗
• MalfunctionOct 15, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PREOPERATIVELY, THE TWO THREAD DETACHES FROM THE SUTURE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: Insufficient Information

  MAUDE report 23305427 ↗
• MalfunctionOct 15, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PREOPERATIVELY, THE TWO THREAD DETACHED FROM THE SUTURE UNEXPECTEDLY. THE STAFF HAD TO REMOVE SEVERAL SUTURES TO FINALLY GET A NEEDLE AND THREAD THAT WORKED PROPERLY TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23298122 ↗
• MalfunctionOct 15, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PREOPERATIVELY, THE TWO THREAD DETACHED FROM THE SUTURE UNEXPECTEDLY. THE STAFF HAD TO REMOVE SEVERAL SUTURES TO FINALLY GET A NEEDLE AND THREAD THAT WORKED PROPERLY TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23293002 ↗
• MalfunctionOct 7, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING SUTURING OR PREPARING THE SUTURE AFTER PATIENT INCISION, THE NEEDLE DETACHED FROM THE SEVEN SUTURES. THE NEEDLE DID NOT FALL INTO THE PATIENT CAVITY. AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23230802 ↗
• MalfunctionOct 7, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING SUTURING OR PREPARING THE SUTURE AFTER PATIENT INCISION, THE NEEDLE DETACHED FROM THE SEVEN SUTURES. THE NEEDLE DID NOT FALL INTO THE PATIENT CAVITY. AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23230777 ↗
• MalfunctionSep 24, 2025Break; Break

  IT WAS REPORTED THAT DURING AN OPEN CESARIAN SECTION, WHILE SUTURING , THE SIX SUTURES BROKE. THE SURGEON USED ANOTHER SUTURE TO RESOLVE THIS ISSUE AND COMPLETE THE CASE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23130011 ↗

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