Polysorb GLS-321Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10884521045644), received between Oct 12, 2018 and Nov 11, 2020 — classified as 1 injury, 5 malfunctions.

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

• MalfunctionNov 11, 2020Component Missing; Detachment of Device or Device Component; Component Missing; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, THE NEEDLES WERE NOT IN THE PACKAGE WHEN OPENED. THERE WERE ALSO NEEDLES THAT NEEDLES WERE COMING OFF THE SUTURE AND ONE SWIPED IN THE PATIENT.

  Patient problems: Tissue Damage

  MAUDE report 10825574 ↗
• MalfunctionNov 10, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, INTRAOPERATIVELY, NEEDLES WERE LOOSE ON THE STRAND AND CAME OFF. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10815531 ↗
• MalfunctionJun 22, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, BOTH THE NEEDLE AND THREAD OF TWO SUTURES ARE NOT CONNECTED REPEATEDLY WHEN REMOVED FROM THE PACKAGING. A THIRD SUTURE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient; Radiation Exposure, Unintended

  MAUDE report 10179330 ↗
• MalfunctionMay 5, 2019Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A DUAL CHAMBER PACEMAKER PROCEDURE, WHILE DOING A RUNNING STITCH TO CLOSE SUB DERMAL TISSUE DURING CLOSURE OF THE UPPER CHEST WALL, THE NEEDLE BROKE INTO 2 PIECES AND FELL INTO THE PATIENT'S CAVITY BUT WERE RETRIEVED. THEY USED NEW SUTURE TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8580887 ↗
• MalfunctionApr 9, 2019Break; Break

  ACCORDING TO THE REPORTER, WHEN TYING THE KNOT ON AN OPEN PROCEDURE, THE THREAD BROKE. THEY TOOK ANOTHER DEVICE TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8495785 ↗
• InjuryOct 12, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, THE END OF THE NEEDLE BROKE IN THE PATIENT DURING USE. THEY HAVE TO LOOK FOR THE END OF THE NEEDLE AND IT DELAYED THE END OF THE SURGERY.

  Patient problems: No Code Available; Radiation Exposure, Unintended

  MAUDE report 7960187 ↗

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