Caprosyn SC-691Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10884521034990), received between Jan 6, 2023 and Dec 25, 2025 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (10 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 25, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A CAT OVARIECTOMY, AT THE TIME OF SUTURING, THE SUTURE STRAND WAS TAKEN BUT THE NEEDLE DETACHED IMMEDIATELY FROM THE RETAINER. THE NEEDLE DID NOT FALL INTO THE PATIENT CAVITY. ANOTHER STRAND WAS TAKEN TO FINISH THE PROCEDURE WITHOUT ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23892160 ↗
• MalfunctionDec 24, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING THE VETERINARY CAT OVARIECTOMY, AT THE TIME OF SUTURING, THE SUTURE STRAND WAS TAKEN AND THE NEEDLE DETACHED RIGHT FROM THE RETAINER. THE NEEDLE DID NOT FALL INTO THE PATIENT'S CAVITY. ANOTHER SUTURE WAS USED TO COMPLETE THE CLOSURE AND RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23891476 ↗
• MalfunctionSep 2, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE SUTURE HAD PREMATURE ABSORPTION. THE SUTURE HAD CRUMBLED WHEN IT CAME OUT OF THE PACKAGE. NO INTERVENTION WAS REQUIRED. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22948499 ↗
• MalfunctionSep 5, 2024Break; Break

  ACCORDING TO THE REPORTER, THE SUTURE BROKE WHEN THROWING A KNOT. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20151111 ↗
• MalfunctionJul 19, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRIOR TO USE OF THE DEVICE, BEFORE THE DEVICE WAS REMOVED FROM THE PACKAGING, WHILE THE NEEDLE WAS STILL IN THE RETAINER, THE NEEDLE WAS DETACHED FROM THE THREAD. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19785989 ↗
• MalfunctionFeb 28, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN OPEN HERNIOPLASTY PROCEDURE, AT THE TIME OF SKIN CLOSURE, THE USER OPENED THE SUTURE AND PLACED IT IN THE NEEDLE HOLDER, AND WHEN GRASPED, IT WAS EASILY DETACHED FROM THE STRAND. ANOTHER SUTURE WAS OPENED, AND THE SAME ISSUE HAPPENED. ANOTHER PRODUCT FROM A COMPETITOR'S WAS OPENED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18798261 ↗
• MalfunctionFeb 28, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN OPEN HERNIOPLASTY PROCEDURE, AT THE TIME OF SKIN CLOSURE, THE USER OPENED THE SUTURE AND PLACED IT IN THE NEEDLE HOLDER, AND WHEN GRASPED, IT WAS EASILY DETACHED FROM THE STRAND. ANOTHER SUTURE WAS OPENED, AND THE SAME ISSUE HAPPENED. ANOTHER PRODUCT FROM A COMPETITOR'S WAS OPENED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18798253 ↗
• MalfunctionOct 13, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, INTRAOPERATIVELY, WHEN THE USER OPENED THE SUTURE PACKAGE, IT NOTICE THAT THE NEEDLE IS LOOSE FROM THE THREAD.

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

  MAUDE report 17934756 ↗
• MalfunctionOct 13, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, INTRAOPERATIVELY, CHOLECYSTECTOMY, WHEN THE USER OPENED THE SUTURE PACKAGE, IT NOTICE THAT THE NEEDLE WAS LOOSE FROM THE THREAD. THERE WAS NO PATIENT INJURY.

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

  MAUDE report 17934707 ↗
• MalfunctionMar 16, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, INTRAOPERATIVELY, THE THREE THREAD OF THE DEVICE BROKE AT THE LEVEL OF THE NEEDLE. PRODUCT WAS RECEIVED WITHOUT ACCOMPANYING INFORMATION.

  Patient problems: Insufficient Information

  MAUDE report 16553283 ↗
• MalfunctionJan 10, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, INTRAOPERATIVELY, THE THREE THREADS OF THE DEVICE BROKE AT THE LEVEL OF THE NEEDLE.

  Patient problems: Insufficient Information

  MAUDE report 16131043 ↗
• MalfunctionJan 6, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN INTRACUTANEOUS CLOSURE, BEFORE USING ON THE PATIENT, FIVE OF THE NEEDLES CAME OFF THE THREAD WHEN THE NURSE TOOK THE THREAD OUT OF THE PACKAGE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16112311 ↗