Caprosyn SC-543Recalls & reported problems

Summary

The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 10884521034709), received between Jul 18, 2019 and Nov 19, 2025 — classified as 37 malfunctions.

The most frequently reported specific device problem is “Break” (30 reports).

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 37 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 19, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A NASAL SEPTUM PROCEDURE, PRIOR TO PATIENT INCISION, THE NEEDLE DETACHED FROM THE SUTURE WHILE REMOVING IT FROM THE RETAINER AND PREPARING THE SUTURE FOR USE. THIS ISSUE OCCURRED ON TWO DEVICES. 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 23596911 ↗
• MalfunctionNov 19, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A NASAL SEPTUM PROCEDURE, PRIOR TO PATIENT INCISION, THE NEEDLE DETACHED FROM THE SUTURE WHILE REMOVING IT FROM THE RETAINER AND PREPARING THE SUTURE FOR USE. THIS ISSUE OCCURRED ON TWO DEVICES. 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 23596901 ↗
• MalfunctionAug 12, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER DURING A HIP PROCEDURE, DURING SUTURING, THE NEEDLE CAME LOOSE FROM THE THREAD. THE ISSUE OCCURRED ON FOUR SUTURES WITH THE SAME BATCH NUMBER, ANOTHER THREE FROM A DIFFERENT BATCH NUMBER, AND ANOTHER ONE FROM ANOTHER BATCH. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22784019 ↗
• MalfunctionAug 12, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER DURING A HIP PROCEDURE, DURING SUTURING, THE NEEDLE CAME LOOSE FROM THE THREAD. THE ISSUE OCCURRED ON FOUR SUTURES WITH THE SAME BATCH NUMBER, ANOTHER THREE FROM A DIFFERENT BATCH NUMBER, AND ANOTHER ONE FROM ANOTHER BATCH. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22783935 ↗
• MalfunctionAug 12, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER DURING A HIP PROCEDURE, DURING SUTURING, THE NEEDLE CAME LOOSE FROM THE THREAD. THE ISSUE OCCURRED ON FOUR SUTURES WITH THE SAME BATCH NUMBER, ANOTHER THREE FROM A DIFFERENT BATCH NUMBER, AND ANOTHER ONE FROM ANOTHER BATCH. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22783531 ↗
• MalfunctionAug 7, 2025Break; Break

  IT WAS REPORTED THAT DURING A SURGERY, THE SUTURES STRAND BROKE IN THE MIDDLE WHEN TENSION WAS APPLIED TO TIGHTEN THE KNOT.

  Patient problems: Insufficient Information

  MAUDE report 22745395 ↗
• MalfunctionJul 30, 2025Break; Break

  IT WAS REPORTED THAT DURING A C-SECTION SURGERY, THE SIX SUTURES STRAND BROKE IN THE MIDDLE WHEN TENSION WAS APPLIED TO TIGHTEN THE KNOT. THE ISSUE WAS RESOLVED BY USING ANOTHER SUTURE FROM A DIFFERENT LOT NUMBER. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22665854 ↗
• MalfunctionJul 30, 2025Break; Break

  IT WAS REPORTED THAT DURING A C-SECTION SURGERY, THE SIX SUTURES STRAND BROKE IN THE MIDDLE WHEN TENSION WAS APPLIED TO TIGHTEN THE KNOT. THE ISSUE WAS RESOLVED BY USING ANOTHER SUTURE FROM A DIFFERENT LOT NUMBER. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22665722 ↗
• MalfunctionJul 30, 2025Break; Break

  IT WAS REPORTED THAT DURING A C-SECTION SURGERY, THE SIX SUTURES STRAND BROKE IN THE MIDDLE WHEN TENSION WAS APPLIED TO TIGHTEN THE KNOT. THE ISSUE WAS RESOLVED BY USING ANOTHER SUTURE FROM A DIFFERENT LOT NUMBER. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22665611 ↗
• MalfunctionJul 30, 2025Break; Break

  IT WAS REPORTED THAT DURING A C-SECTION SURGERY, THE SIX SUTURES STRAND BROKE IN THE MIDDLE WHEN TENSION WAS APPLIED TO TIGHTEN THE KNOT. THE ISSUE WAS RESOLVED BY USING ANOTHER SUTURE FROM A DIFFERENT LOT NUMBER. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22665432 ↗
• MalfunctionJul 30, 2025Break; Break

  IT WAS REPORTED THAT DURING A C-SECTION SURGERY, THE SIX SUTURES STRAND BROKE IN THE MIDDLE WHEN TENSION WAS APPLIED TO TIGHTEN THE KNOT. THE ISSUE WAS RESOLVED BY USING ANOTHER SUTURE FROM A DIFFERENT LOT NUMBER. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22665390 ↗
• MalfunctionJul 30, 2025Break; Break

  IT WAS REPORTED THAT DURING A C-SECTION SURGERY, THE SIX SUTURES STRAND BROKE IN THE MIDDLE WHEN TENSION WAS APPLIED TO TIGHTEN THE KNOT. THE ISSUE WAS RESOLVED BY USING ANOTHER SUTURE FROM A DIFFERENT LOT NUMBER. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22665336 ↗
• MalfunctionJul 15, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER DURING A HIP PROCEDURE, DURING SUTURING THE NEEDLE CAME LOOSE FROM THE THREAD. THE ISSUE OCCURRED ON THREE SUTURES FROM THE SAME BATCH AND TWO OF THE SAME MODELS BUT FROM A DIFFERENT BATCH. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22505941 ↗
• MalfunctionJul 15, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER DURING A HIP PROCEDURE, DURING SUTURING THE NEEDLE CAME LOOSE FROM THE THREAD. THE ISSUE OCCURRED ON THREE SUTURES FROM THE SAME BATCH AND TWO OF THE SAME MODELS BUT FROM A DIFFERENT BATCH. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22505929 ↗
• MalfunctionJun 3, 2025Break; Break

  IT WAS REPORTED THAT DURING A HYSTERECTOMY, THE SUTURE BROKE. IT WAS NOTED THAT TWO TO THREE SUTURES WERE USED AND HAD THE SAME ISSUE. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22131992 ↗
• MalfunctionJun 3, 2025Break; Break

  IT WAS REPORTED THAT DURING A HYSTERECTOMY, THE SUTURE BROKE. IT WAS NOTED THAT TWO TO THREE SUTURES WERE USED AND HAD THE SAME ISSUE. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22131935 ↗
• MalfunctionJun 3, 2025Break; Break

  IT WAS REPORTED THAT DURING A HYSTERECTOMY, THE SUTURE BROKE. IT WAS NOTED THAT TWO TO THREE SUTURES WERE USED AND HAD THE SAME ISSUE. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22131892 ↗
• MalfunctionMay 20, 2025Break; Break

  IT WAS REPORTED THAT DURING A HYSTERECTOMY, THE SUTURE BROKE. IT WAS NOTED THAT TWO TO THREE SUTURES WERE USED AND HAD THE SAME ISSUE. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22050941 ↗
• MalfunctionMay 20, 2025Break; Break

  IT WAS REPORTED THAT DURING A HYSTERECTOMY, THE SUTURE BROKE. IT WAS NOTED THAT TWO TO THREE SUTURES WERE USED AND HAD THE SAME ISSUE. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22050906 ↗
• MalfunctionMay 20, 2025Break; Break

  IT WAS REPORTED THAT DURING A HYSTERECTOMY, THE SUTURE BROKE. IT WAS NOTED THAT TWO TO THREE SUTURES WERE USED AND HAD THE SAME ISSUE. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22050897 ↗
• MalfunctionMay 20, 2025Break; Break

  IT WAS REPORTED THAT DURING A HYSTERECTOMY, THE SUTURE BROKE. IT WAS NOTED THAT TWO TO THREE SUTURES WERE USED AND HAD THE SAME ISSUE. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22050863 ↗
• MalfunctionMay 20, 2025Break; Break

  IT WAS REPORTED THAT DURING A HYSTERECTOMY, THE SUTURE BROKE. IT WAS NOTED THAT TWO TO THREE SUTURES WERE USED AND HAD THE SAME ISSUE. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22050846 ↗
• MalfunctionMay 20, 2025Break; Break

  IT WAS REPORTED THAT DURING A HYSTERECTOMY, THE SUTURE BROKE. IT WAS NOTED THAT TWO TO THREE SUTURES WERE USED AND HAD THE SAME ISSUE. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22050835 ↗
• MalfunctionMay 20, 2025Break; Break

  IT WAS REPORTED THAT DURING A HYSTERECTOMY, THE SUTURE BROKE. IT WAS NOTED THAT TWO TO THREE SUTURES WERE USED AND HAD THE SAME ISSUE. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22050800 ↗
• MalfunctionMay 20, 2025Break; Break

  IT WAS REPORTED THAT DURING A HYSTERECTOMY, THE SUTURE BROKE. IT WAS NOTED THAT TWO TO THREE SUTURES WERE USED AND HAD THE SAME ISSUE. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22050789 ↗