SharpSafety 8556HRecalls & reported problems

Summary

The FDA's MAUDE database contains 65 adverse event reports that list this exact device (DI 10884521019119), received between Nov 26, 2025 and May 8, 2026 — classified as 65 malfunctions.

The most frequently reported specific device problem is “Device Contaminated During Manufacture or Shipping” (58 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 65 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 8, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO SEW THE TISSUE. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE IS NO REPORT ON PATIENT'S INJURY. THERE WILL RETURN 17 REPRESENTATIVE SAMPLES FOR ANALYSIS . NO ADDITIONAL INFORMATION COULD BE PROVIDED. THE LOT OF IP IS UNAVAILABLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25128115 ↗
• MalfunctionMay 7, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CONGENITAL HEART DISEASE, ATRIOVENTRICULAR DEFECT SURGERY PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, IT'S REPORTED THAT IN CONGENITAL HEART DISEASE, ATRIOVENTRICULAR DEFECT SURGERY, CONTINUED SEWING WAS PERFORMED WHEN SEWING THE PATCH TO THE HEART, AND CONSECUTIVE 4 SUTURES WERE BROKEN, PROLONGING THE OPERATION TIME. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25111007 ↗
• MalfunctionMay 7, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CONGENITAL HEART DISEASE, ATRIOVENTRICULAR DEFECT SURGERY PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, IT'S REPORTED THAT IN CONGENITAL HEART DISEASE, ATRIOVENTRICULAR DEFECT SURGERY, CONTINUED SEWING WAS PERFORMED WHEN SEWING THE PATCH TO THE HEART, AND CONSECUTIVE 4 SUTURES WERE BROKEN, PROLONGING THE OPERATION TIME. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25111004 ↗
• MalfunctionMay 7, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CONGENITAL HEART DISEASE, ATRIOVENTRICULAR DEFECT SURGERY PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, IT'S REPORTED THAT IN CONGENITAL HEART DISEASE, ATRIOVENTRICULAR DEFECT SURGERY, CONTINUED SEWING WAS PERFORMED WHEN SEWING THE PATCH TO THE HEART, AND CONSECUTIVE 4 SUTURES WERE BROKEN, PROLONGING THE OPERATION TIME. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25111001 ↗
• MalfunctionMay 7, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CONGENITAL HEART DISEASE, ATRIOVENTRICULAR DEFECT SURGERY PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, IT'S REPORTED THAT IN CONGENITAL HEART DISEASE, ATRIOVENTRICULAR DEFECT SURGERY, CONTINUED SEWING WAS PERFORMED WHEN SEWING THE PATCH TO THE HEART, AND CONSECUTIVE 4 SUTURES WERE BROKEN, PROLONGING THE OPERATION TIME. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25110999 ↗
• MalfunctionMay 6, 2026Material Separation; Material Twisted/Bent

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BY-PASS PROCEDURE IN 2026 AND SUTURE WAS USED. DURING SEWING ON BY-PASS OP, THE NEEDLE HAD COME OFF THE THREAD WITH SEVERAL SEAMS. IN ADDITION, THE NEEDLE OF THE LAST AFFECTED SUTURE WAS BENT AT THE SWAGED AREA. NO PATIENT HARM OCCURRED. USING NEW SUTURES FROM THESE LOTS, THE SURGICAL PROCEDURE WAS CONTINUED AS PLANNED AND COMPLETED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25095804 ↗
• MalfunctionMay 6, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BY-PASS PROCEDURE IN 2026 AND SUTURE WAS USED. DURING SEWING ON BY-PASS OP, THE NEEDLE HAD COME OFF THE THREAD WITH SEVERAL SEAMS. IN ADDITION, THE NEEDLE OF THE LAST AFFECTED SUTURE WAS BENT AT THE SWAGED AREA. NO PATIENT HARM OCCURRED. USING NEW SUTURES FROM THESE LOTS, THE SURGICAL PROCEDURE WAS CONTINUED AS PLANNED AND COMPLETED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25095801 ↗
• MalfunctionDec 8, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED A NEEDLE PORTION HAD FOREIGN MATTER (MICROSCOPIC PARTICLES) FOUND ON SUTURE. CUSTOMER HAS ADVISED THE PRODUCT IS NOT IN ITS ORIGINAL SALES BOXES. FOUND PRIOR TO USE IN COOK DEVICES AND NOT IN A SURGICAL PROCEDURE. NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23746620 ↗
• MalfunctionDec 8, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED A NEEDLE PORTION HAD FOREIGN MATTER (MICROSCOPIC PARTICLES) FOUND ON SUTURE. CUSTOMER HAS ADVISED THE PRODUCT IS NOT IN ITS ORIGINAL SALES BOXES. FOUND PRIOR TO USE IN COOK DEVICES AND NOT IN A SURGICAL PROCEDURE. NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23746526 ↗
• MalfunctionDec 8, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED A NEEDLE PORTION HAD FOREIGN MATTER (MICROSCOPIC PARTICLES) FOUND ON SUTURE. CUSTOMER HAS ADVISED THE PRODUCT IS NOT IN ITS ORIGINAL SALES BOXES. FOUND PRIOR TO USE IN COOK DEVICES AND NOT IN A SURGICAL PROCEDURE. NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23746506 ↗
• MalfunctionDec 8, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED A NEEDLE PORTION HAD FOREIGN MATTER (MICROSCOPIC PARTICLES) FOUND ON SUTURE. CUSTOMER HAS ADVISED THE PRODUCT IS NOT IN ITS ORIGINAL SALES BOXES. FOUND PRIOR TO USE IN COOK DEVICES AND NOT IN A SURGICAL PROCEDURE. NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23746486 ↗
• MalfunctionDec 8, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED A NEEDLE PORTION HAD FOREIGN MATTER (MICROSCOPIC PARTICLES) FOUND ON SUTURE. CUSTOMER HAS ADVISED THE PRODUCT IS NOT IN ITS ORIGINAL SALES BOXES. FOUND PRIOR TO USE IN COOK DEVICES AND NOT IN A SURGICAL PROCEDURE. NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23746411 ↗
• MalfunctionDec 8, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED A NEEDLE PORTION HAD FOREIGN MATTER (MICROSCOPIC PARTICLES) FOUND ON SUTURE. CUSTOMER HAS ADVISED THE PRODUCT IS NOT IN ITS ORIGINAL SALES BOXES. FOUND PRIOR TO USE IN COOK DEVICES AND NOT IN A SURGICAL PROCEDURE. NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23746408 ↗
• MalfunctionDec 8, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED A NEEDLE PORTION HAD FOREIGN MATTER (MICROSCOPIC PARTICLES) FOUND ON SUTURE. CUSTOMER HAS ADVISED THE PRODUCT IS NOT IN ITS ORIGINAL SALES BOXES. FOUND PRIOR TO USE IN COOK DEVICES AND NOT IN A SURGICAL PROCEDURE. NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23746406 ↗
• MalfunctionDec 8, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED A NEEDLE PORTION HAD FOREIGN MATTER (MICROSCOPIC PARTICLES) FOUND ON SUTURE. CUSTOMER HAS ADVISED THE PRODUCT IS NOT IN ITS ORIGINAL SALES BOXES. FOUND PRIOR TO USE IN COOK DEVICES AND NOT IN A SURGICAL PROCEDURE. NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23746387 ↗
• MalfunctionDec 8, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED A NEEDLE PORTION HAD FOREIGN MATTER (MICROSCOPIC PARTICLES) FOUND ON SUTURE. CUSTOMER HAS ADVISED THE PRODUCT IS NOT IN ITS ORIGINAL SALES BOXES. FOUND PRIOR TO USE IN COOK DEVICES AND NOT IN A SURGICAL PROCEDURE. NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23746257 ↗
• MalfunctionDec 8, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED A NEEDLE PORTION HAD FOREIGN MATTER (MICROSCOPIC PARTICLES) FOUND ON SUTURE. CUSTOMER HAS ADVISED THE PRODUCT IS NOT IN ITS ORIGINAL SALES BOXES. FOUND PRIOR TO USE IN COOK DEVICES AND NOT IN A SURGICAL PROCEDURE. NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23746256 ↗
• MalfunctionDec 8, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED A NEEDLE PORTION HAD FOREIGN MATTER (MICROSCOPIC PARTICLES) FOUND ON SUTURE. CUSTOMER HAS ADVISED THE PRODUCT IS NOT IN ITS ORIGINAL SALES BOXES. FOUND PRIOR TO USE IN COOK DEVICES AND NOT IN A SURGICAL PROCEDURE. NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23746011 ↗
• MalfunctionDec 8, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED A NEEDLE PORTION HAD FOREIGN MATTER (MICROSCOPIC PARTICLES) FOUND ON SUTURE. CUSTOMER HAS ADVISED THE PRODUCT IS NOT IN ITS ORIGINAL SALES BOXES. FOUND PRIOR TO USE IN COOK DEVICES AND NOT IN A SURGICAL PROCEDURE. NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23746001 ↗
• MalfunctionDec 8, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED A NEEDLE PORTION HAD FOREIGN MATTER (MICROSCOPIC PARTICLES) FOUND ON SUTURE. CUSTOMER HAS ADVISED THE PRODUCT IS NOT IN ITS ORIGINAL SALES BOXES. FOUND PRIOR TO USE IN COOK DEVICES AND NOT IN A SURGICAL PROCEDURE. NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23745995 ↗
• MalfunctionDec 8, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED A NEEDLE PORTION HAD FOREIGN MATTER (MICROSCOPIC PARTICLES) FOUND ON SUTURE. CUSTOMER HAS ADVISED THE PRODUCT IS NOT IN ITS ORIGINAL SALES BOXES. FOUND PRIOR TO USE IN COOK DEVICES AND NOT IN A SURGICAL PROCEDURE. NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23745941 ↗
• MalfunctionDec 8, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED A NEEDLE PORTION HAD FOREIGN MATTER (MICROSCOPIC PARTICLES) FOUND ON SUTURE. CUSTOMER HAS ADVISED THE PRODUCT IS NOT IN ITS ORIGINAL SALES BOXES. FOUND PRIOR TO USE IN COOK DEVICES AND NOT IN A SURGICAL PROCEDURE. NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23745929 ↗
• MalfunctionDec 8, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED A NEEDLE PORTION HAD FOREIGN MATTER (MICROSCOPIC PARTICLES) FOUND ON SUTURE. CUSTOMER HAS ADVISED THE PRODUCT IS NOT IN ITS ORIGINAL SALES BOXES. FOUND PRIOR TO USE IN COOK DEVICES AND NOT IN A SURGICAL PROCEDURE. NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23745927 ↗
• MalfunctionDec 8, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED A NEEDLE PORTION HAD FOREIGN MATTER (MICROSCOPIC PARTICLES) FOUND ON SUTURE. CUSTOMER HAS ADVISED THE PRODUCT IS NOT IN ITS ORIGINAL SALES BOXES. FOUND PRIOR TO USE IN COOK DEVICES AND NOT IN A SURGICAL PROCEDURE. NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23745913 ↗
• MalfunctionDec 8, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED A NEEDLE PORTION HAD FOREIGN MATTER (MICROSCOPIC PARTICLES) FOUND ON SUTURE. CUSTOMER HAS ADVISED THE PRODUCT IS NOT IN ITS ORIGINAL SALES BOXES. FOUND PRIOR TO USE IN COOK DEVICES AND NOT IN A SURGICAL PROCEDURE. NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23745902 ↗