PDS D8832Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10705031031319), received between Nov 26, 2018 and Apr 27, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 27, 2026Component Misassembled

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY A SALES REP THAT, DURING AN UNKNOWN SURGERY, THAT D8832 HAS THE SAME PRODUCT NUMBER BUT A DIFFERENT THE PET NAME OF THE NEEDLE (NEEDLE SHAPE) FROM THE OPERATING ROOM. IT WAS CONFIRMED THAT ONE WAS CTXB AND THE OTHER WAS D8832, THE SAME AS BP-2, BUT THE PET NAME PRINTED ON THE PACKAGE WAS DIFFERENT WHEN THE PHOTO WAS CHECKED. SINCE THE CATALOG LISTS BP-2 AS A CURRENT PRODUCT, IT IS LIKELY THAT CTXB SPECIFICATION IS A DEFECTIVE PRODUCT. THIS EVENT WAS FOUND BEFORE USE. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. WHEN WE SEND THE SAMPLE TO YOU, WE WILL LET YOU KNOW ITS RETURN DATE AND TRACKING NUMBER. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. FURTHER DETAILS ARE NOT PROVIDED FROM THE HP. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25000327 ↗
• MalfunctionApr 27, 2026Component Misassembled

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY A SALES REP THAT, DURING AN UNKNOWN SURGERY, THAT D8832 HAS THE SAME PRODUCT NUMBER BUT A DIFFERENT THE PET NAME OF THE NEEDLE (NEEDLE SHAPE) FROM THE OPERATING ROOM. IT WAS CONFIRMED THAT ONE WAS CTXB AND THE OTHER WAS D8832, THE SAME AS BP-2, BUT THE PET NAME PRINTED ON THE PACKAGE WAS DIFFERENT WHEN THE PHOTO WAS CHECKED. SINCE THE CATALOG LISTS BP-2 AS A CURRENT PRODUCT, IT IS LIKELY THAT CTXB SPECIFICATION IS A DEFECTIVE PRODUCT. THIS EVENT WAS FOUND BEFORE USE. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. WHEN WE SEND THE SAMPLE TO YOU, WE WILL LET YOU KNOW ITS RETURN DATE AND TRACKING NUMBER. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. FURTHER DETAILS ARE NOT PROVIDED FROM THE HP. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25000313 ↗
• MalfunctionMar 20, 2020Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE WAS BROKEN AT THE SWAGE PART AROUND THE 3RD STITCH DURING CONTINUOUS SUTURING ON THE FASCIA. NO PIECES FELL INTO THE SURGICAL FIELD, AND IT WAS RETRIEVED. FURTHER DETAILS WERE NOT PROVIDED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9861351 ↗
• MalfunctionJan 9, 2019Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2018, AND SUTURE WAS USED. THE SUTURE BROKE WHEN PULLING THROUGH THE FASCIA DURING THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8232523 ↗
• MalfunctionNov 26, 2018Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2018 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS BROKEN EASILY DURING CONTINUOUS SUTURING. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8101816 ↗