Polysorb CL-829Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10884521042063), received between Jan 26, 2022 and Jul 13, 2022 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (6 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 13, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE NEEDLE POPPED OFF FROM THE SUTURE WHILE THE SURGEON WAS DOING AN INTERRUPTED SUTURING TECHNIQUE. A NEW SUTURE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15005677 ↗
• MalfunctionJun 13, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY OF ON AN OPEN ORTHOPEDIC PROCEDURE, WHILE USING THE DEVICE WITH AN INTERRUPTED SUTURING TECHNIQUE, THE THREAD DETACHED FROM THE NEEDLE SWAGE. 2 SUTURES HAD THE ISSUE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14676016 ↗
• MalfunctionJun 13, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, 3 NEEDLES POPPED OFF THE SUTURE WHILE TRYING TO CLOSE THE INCISION. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14675955 ↗
• MalfunctionJun 10, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, ON AN OPEN ORTHOPEDIC PODIATRY PROCEDURE, THE SUTURE HAD THE NEEDLES POP OFF WHILE TRYING TO PASS THROUGH TISSUE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14657830 ↗
• MalfunctionApr 12, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE NEEDLE WAS BROKEN. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14086544 ↗
• MalfunctionJan 26, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER DURING THE VASCULAR SURGERY WHILE SUTURING USING THE RUNNING TECHNIQUE, THE THREAD AND NEEDLE OF THE 2 SUTURE DEVICES DETACHED. TO RESOLVE THE ISSUE, THE SURGEON OPENED MORE SUTURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13361706 ↗
• MalfunctionJan 26, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN OPEN VASCULAR SURGERY, WHILE CLOSING A 6 INCH INCISION USING A RUNNING TECHNIQUE, THE THREAD AND NEEDLE ON THE 5 DEVICES ALL POPPED OFF AND DETACHED AS A WHOLE AFTER 1 STITCH. THE SALES REPRESENTATIVE WAS WATCHING TO MAKE SURE THE SURGEON WAS NOT GRABBING THE PRODUCTS IN THE WRONG SPOT OR ANYTHING AND WAS NOT. MORE PACKAGES WERE OPENED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13358800 ↗

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