Caprosyn SC-5617GRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10884521034754), received between Sep 13, 2017 and Jun 24, 2025 — classified as 1 injury, 7 malfunctions.

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

• MalfunctionJun 24, 2025Break; Break

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE NEEDLE BROKE WHILE SUTURING. THE NEEDLE DID NOT FALL INTO THE PATIENT CAVITY. 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 22318525 ↗
• MalfunctionJul 12, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY OF A MOH'S (MICROGRAPHICALLY ORIENTED HISTOGRAPHIC SURGERY) REPAIR, THE THREAD AND NEEDLE SEPARATED WHILE SUTURING THE PATIENT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14988532 ↗
• MalfunctionJun 26, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING USE, THE THREAD AND NEEDLE SEPARATED.

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

  MAUDE report 14823432 ↗
• MalfunctionJun 26, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, THE NEEDLE AND SUTURE SEPARATED WHILE SUTURING A PATIENT.

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

  MAUDE report 14823414 ↗
• MalfunctionJun 26, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN EAR PROCEDURE, MULTIPLE SUTURES HAD NEEDLES DETACHED. IT COULD NOT BE DETERMINED HOW MANY SUTURES WERE DEFECTIVE BUT ALL ARE FROM THE SAME BOX AND ONE BOX HAS A TOTAL OF 12 SUTURES. ANOTHER SUTURE FROM THE SAME BOX WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10200207 ↗
• InjuryMar 10, 2020Break; Break

  ACCORDING TO THE REPORTER, DURING ROBOTIC LAPAROSCOPIC PROCEDURE, THE NEEDLE BROKE AND THE TIP WAS IN PATIENT'S TISSUE. AN X-RAY WAS PERFORMED TO LOCATE THE NEEDLE AND IT WAS ABLE TO BE RETRIEVED.

  Patient problems: No Code Available; Radiation Exposure, Unintended

  MAUDE report 9811295 ↗
• MalfunctionNov 21, 2017Break; Break

  ACCORDING TO THE REPORTER: OCCURRED AT THE END OF A LAPAROSCOPIC PROCEDURE. THE SUTURE WAS BEING USED FOR SUTURING THE SKIN. THE SUTURE THREAD WAS BREAKING WHILE ATTEMPTING TO TIE THE KNOTS. THE SUTURE WAS NOT TREATED OR HYDRATED PRIOR TO USE. THE ABSORBABLE SUTURE WAS USED WITHIN FIVE MINUTES OF OPENING THE PACKAGING. SURGEON FELT THAT THE SUTURE BEING USED DID NOT FEEL LIKE A 4-0 SUTURE, BUT MORE LIKE A 5-0 OR 6-0 SUTURE. IN ORDER TO RESOLVE THE ISSUE AND COMPLETE THE CASE, OPENED A NEW PACKAGE OF THE SUTURE AND CLOSED THE INCISION. THERE WAS NO PATIENT HARM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7048539 ↗
• MalfunctionSep 13, 2017Break; Break

  ACCORDING TO THE REPORTER: OCCURRED DURING AN OPEN FOREHEAD LESION PROCEDURE. THE SUTURE WAS BEING APPLIED TO THE SKIN. THE THREAD OF THE SUTURE BROKE WHEN TYING THE KNOT. THE SURGEON WAS EMPLOYING THE INTERRUPTED SUTURE TECHNIQUE. THE ABSORBABLE SUTURE HAD BEEN OPENED FOR THIRTY MINUTES PRIOR TO USE. IN ORDER TO RESOLVE THE ISSUE AND COMPLETE THE CASE, ANOTHER SUTURE WAS OPENED. THERE WAS NO PATIENT HARM. THE PATIENT OUTCOME IS ALIVE, NO INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6860857 ↗