Caprosyn SC-5640Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10884521034839), received between May 14, 2019 and May 5, 2026 — classified as 2 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (12 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 5, 2026Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, WHILE SUTURING, THE NEEDLE DETACHED. THE USER USED THREE SUTURES UNTIL ONE WORKED.

  Patient problems: Insufficient Information

  MAUDE report 25081977 ↗
• MalfunctionMay 5, 2026Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, WHILE SUTURING, THE NEEDLE DETACHED. THE USER USED THREE SUTURES UNTIL ONE WORKED.

  Patient problems: Insufficient Information

  MAUDE report 25081969 ↗
• MalfunctionMay 5, 2026Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, WHILE SUTURING, THE NEEDLE DETACHED. THE USER USED THREE SUTURES UNTIL ONE WORKED.

  Patient problems: Insufficient Information

  MAUDE report 25081838 ↗
• MalfunctionAug 30, 2022Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, AT THE END OF THE OPEN CORONARY ARTERY BYPASS GRAFT WHERE THE SKIN WAS RIPPED MANY TIMES WHILE SUCTIONING, THE FIRST KNOT WHEN SUTURING SKIN AND DURING CONTINUOUS SUTURING, 9 THREADS BROKE AND THE THREADS LEFT FROM THE NEEDLES. A NEW PRODUCT WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15322271 ↗
• MalfunctionAug 30, 2022Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, AT THE END OF THE OPEN CORONARY ARTERY BYPASS GRAFT WHERE THE SKIN WAS RIPPED MANY TIMES WHILE SUCTIONING, THE FIRST KNOT WHEN SUTURING SKIN AND DURING CONTINUOUS SUTURING, 9 THREADS BROKE AND THE THREADS LEFT FROM THE NEEDLES. A NEW PRODUCT WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15322230 ↗
• MalfunctionAug 29, 2022Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, AT THE END OF THE OPEN CORONARY ARTERY BYPASS GRAFT WHERE THE SKIN WAS RIPPED MANY TIMES WHILE SUCTIONING, THE FIRST KNOT WHEN SUTURING SKIN AND DURING CONTINUOUS SUTURING, NINE THREADS BROKE AND THE THREADS LEFT FROM THE NEEDLES. A NEW PRODUCT WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15311923 ↗
• MalfunctionAug 29, 2022Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, AT THE END OF THE OPEN CORONARY ARTERY BYPASS GRAFT WHERE THE SKIN WAS RIPPED MANY TIMES WHILE SUCTIONING, THE FIRST KNOT WHEN SUTURING SKIN AND DURING CONTINUOUS SUTURING, NINE THREADS BROKE AND THE THREADS LEFT FROM THE NEEDLES. A NEW PRODUCT WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15311868 ↗
• MalfunctionAug 29, 2022Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, AT THE END OF THE OPEN CORONARY ARTERY BYPASS GRAFT WHERE THE SKIN WAS RIPPED MANY TIMES WHILE SUCTIONING, THE FIRST KNOT WHEN SUTURING SKIN AND DURING CONTINUOUS SUTURING, NINE THREADS BROKE AND THE THREADS LEFT FROM THE NEEDLES. A NEW PRODUCT WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15311775 ↗
• MalfunctionAug 29, 2022Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, AT THE END OF THE OPEN CORONARY ARTERY BYPASS GRAFT WHERE THE SKIN WAS RIPPED MANY TIMES WHILE SUCTIONING, THE FIRST KNOT WHEN SUTURING SKIN AND DURING CONTINUOUS SUTURING, NINE THREADS BROKE AND THE THREADS LEFT FROM THE NEEDLES. A NEW PRODUCT WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15311707 ↗
• MalfunctionAug 29, 2022Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, AT THE END OF THE OPEN CORONARY ARTERY BYPASS GRAFT WHERE THE SKIN WAS RIPPED MANY TIMES WHILE SUCTIONING, THE FIRST KNOT WHEN SUTURING SKIN AND DURING CONTINUOUS SUTURING, NINE THREADS BROKE AND THE THREADS LEFT FROM THE NEEDLES. A NEW PRODUCT WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15311623 ↗
• MalfunctionAug 10, 2022Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, AT THE END OF THE OPEN CORONARY ARTERY BYPASS GRAFT WHERE THE SKIN WAS RIPPED MANY TIMES WHILE SUCTIONING, THE FIRST KNOT WHEN SUTURING SKIN AND DURING CONTINUOUS SUTURING, THE THREAD BROKE AND THE THREAD LEFT FROM THE NEEDLE. A NEW PRODUCT WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15203325 ↗
• MalfunctionAug 10, 2022Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, AT THE END OF THE OPEN CORONARY ARTERY BYPASS GRAFT WHERE THE SKIN WAS RIPPED MANY TIMES WHILE SUCTIONING, THE FIRST KNOT WHEN SUTURING SKIN AND DURING CONTINUOUS SUTURING, THE THREAD BROKE AND THE THREAD LEFT FROM THE NEEDLE. A NEW PRODUCT WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15203186 ↗
• InjuryJun 9, 2019Break; Break

  ACCORDING TO THE REPORTER, DURING A HIP REPLACEMENT PROCEDURE, THE TIP OF THE NEEDLE BROKE DURING THE OPERATION. X-RAY WAS DONE TO LOCATE THE NEEDLE, BUT NO TRACE OF NEEDLES WAS FOUND SO THE SCRUB TEAM HAD TO MANUALLY SEARCH FOR THE TIP ON THE FLOOR USING A MAGNET. THE TIP OF THE NEEDLE WAS FOUND ON THE FLOOR.

  Patient problems: Radiation Exposure, Unintended

  MAUDE report 8681362 ↗
• InjuryMay 14, 2019Break; Break

  ACCORDING TO THE REPORTER, DURING TOTAL HIP REPLACEMENT, THE NEEDLE TIP PINGED OFF WHEN THEY WERE DOING THE SECOND TO LAST STITCH. IT WAS ALSO REPORTED THAT X-RAY WAS PERFORMED TO MAKE SURE IT HAD NOT FALLEN INTO THE PATIENT. FORTUNATELY, IT HAD FALLEN ONTO THE FLOOR AND THE SCRUB NURSE HAD TO USE A MAGNET TO LOCATE IT. THIS RESULTED TO MINOR TISSUE DAMAGE AND EXTENDED SURGICAL TIME OF EXTRA 40 MINUTES. ANOTHER SUTURE WAS OPENED AND USED TO COMPLETE THE CASE.

  Patient problems: No Code Available; Radiation Exposure, Unintended

  MAUDE report 8607434 ↗