Polysorb SL-5691GRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10884521048805), received between Apr 19, 2019 and Sep 26, 2024 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 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 26, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN OPEN PROCEDURE, WHILE CLOSING THE SCALP AFTER THE INCISION, THE NEEDLE CAME OFF AND FELL INTO THE PATIENT CAVITY. IMAGING WAS REQUIRED TO LOCATE THE NEEDLE BUT THE NEEDLE WAS LOST. THE SURGEON WAS UNABLE TO LOCATE IT. A DIFFERENT SUTURE WAS THEN USED. THE PATIENT WOULD HAVE TO COMEBACK AFTER THE SWELLING GOES DOWN TO REMOVE THE OBJECT. ADDITIONAL SURGERY WAS PERFORMED AS PART OF THE INTERVENTION.

  Patient problems: Foreign Body In Patient; Swelling/ Edema; Unintended Radiation Exposure

  MAUDE report 20311492 ↗
• MalfunctionOct 18, 2022Break; Dull, Blunt; Break; Dull, Blunt

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE NEEDLE SEEMED FLIMSY OR DULL. MADE SUTURING DIFFICULT. THE SUTURE BREAKS AT THE KNOT AFTER TWO THROWS WHEN TYING A DEEP BURIED MATTRESS STITCH AND THE THREAD WILL BREAK AND THE SURGEON WILL RE-USE THE SAME NEEDLE OR THREAD AND IT WILL BREAK AGAIN.

  Patient problems: Insufficient Information

  MAUDE report 15626253 ↗
• MalfunctionAug 19, 2022Break; Break

  ACCORDING TO THE REPORTER, FIVE OF THE NEEDLES BROKE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 15259445 ↗
• MalfunctionDec 2, 2021Mechanical Problem; Patient-Device Incompatibility; Mechanical Problem; Patient-Device Incompatibility

  ACCORDING TO THE REPORTER, POST-OPERATIVELY, THE SUTURES WERE NOT ABSORBING IN THE PATIENT. THE DOCTOR HAD TO GO IN AND CUT OUT THE SUTURES. THE SUTURE CAME UP THROUGH THE SKIN AND FORMED A HOLE THAT LOOKED LIKE A SCAB BUT THE SUTURE CAN BE SEEN IN THERE.

  Patient problems: Insufficient Information

  MAUDE report 12915441 ↗
• MalfunctionOct 1, 2019Break; Break

  ACCORDING TO THE REPORTER, DURING A UMBILICAL HERNIA PROCEDURE, THE NEEDLE PART OF THE DEVICE BROKE. ANOTHER SUTURE WAS OPENED AND USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9141915 ↗
• MalfunctionJun 26, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC CHOLECYSTECTOMY, WHILE USING A RUNNING STITCH TO CLOSE PORT, THE NEEDLE POPPED OFF THE SUTURE. THEY OPENED ANOTHER DEVICE TO COMPLETE THE CASE. NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8733283 ↗
• MalfunctionMay 12, 2019Break; Break

  ACCORDING TO THE REPORTER, WHEN SUTURING THE SKIN DURING AN OPEN PROCEDURE, A COUPLE OF THREAD BROKE. THEY OPENED ANOTHER SUTURE TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8602415 ↗
• MalfunctionApr 19, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN OPEN PROCEDURE, WHILE CLOSING THE SKIN, THE NEEDLE WAS BREAKING FROM THE MATERIAL CONSISTENTLY FROM THE BOX. ANOTHER SUTURE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8533516 ↗

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