Caprosyn SC-5637GRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10884521034815), received between Dec 26, 2019 and Sep 22, 2026 — classified as 2 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (4 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. 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 22, 2026Break; Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50859872 ↗
• MalfunctionFeb 20, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT PREOPERATIVELY, WHEN THE NURSE OPENED THE PACKAGING, THE NEEDLE WAS HELD WHILE REMOVING FROM THE RETAINER AND PREPARING THE SUTURE PRIOR TO PATIENT INCISION. THE THREAD REMAINED IN THE PACKAGE AND NOT ATTACHED TO THE NEEDLE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21426846 ↗
• MalfunctionApr 29, 2024Break; Product Quality Problem; Break; Product Quality Problem

  ACCORDING TO THE REPORTER, PRIOR TO LAPAROSCOPIC CHOLECYSTECTOMY SURGERY, THE SUTURE THREAD CAME OFF WITHOUT BEING TOUCHED BY TOOLS AT THE RELEVANT SITES. UPON CLOSER INSPECTION OF THE THREAD, UNEVENNESS WAS BOTH SEEN AND FELT. ANOTHER SUTURE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19204818 ↗
• MalfunctionNov 18, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN OPEN PROCEDURE, WHEN OPENING THE SUTURE ENVELOPE, THE THREAD WAS SEPARATED FROM THE NEEDLE. ANOTHER SUTURE WAS OPENED TO COMPLETE THE CASE AND RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15827898 ↗
• MalfunctionDec 17, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN OPEN BREAST REDUCTION PROCEDURE, THE THREAD COMES OR SEPARATE OUT OF THE NEEDLE AS A WHOLE WHEN OPENING THE BLISTER. IT WAS NOTED THAT THE MALFUNCTIONED HAPPENED THREE TIMES ON THE SAME DEVICE. TO RESOLVE THE ISSUE, A NEW SUTURE WITH THE SAME LOT WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13024779 ↗
• InjurySep 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, 26 DAYS POST-OPERATIVE, WHEN SURGEON BEGAN TO EXPEL THE STITCHES, LEAVING A SLIGHT DEHISCENCE IN THE PLACES WHERE THE THREADS WERE REMOVED. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Post Operative Wound Infection; Wound Dehiscence

  MAUDE report 12542508 ↗
• InjurySep 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, 17 DAYS POST-OPERATIVE, WHEN SURGEON BEGAN TO EXPEL THE STITCHES, LEAVING A SLIGHT DEHISCENCE IN THE PLACES WHERE THE THREADS WERE REMOVED. NO PATIENT INJURY.

  Patient problems: Impaired Healing; No Clinical Signs, Symptoms or Conditions; Post Operative Wound Infection; Wound Dehiscence

  MAUDE report 12542474 ↗
• MalfunctionDec 26, 2019Break; Break

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE SUTURE THREAD BROKE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9519324 ↗