PDS Z464HRecalls & reported problems

Summary

The FDA's MAUDE database contains 70 adverse event reports that list this exact device (DI 10705031462519), received between Oct 29, 2018 and Mar 13, 2026 — classified as 70 malfunctions.

The most frequently reported specific device problem is “Break” (48 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 25 most recent of 70 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 13, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WERE USED. DURING SURGERY, THE SUTURE WAS BROKEN DURING USE. IT WAS NOT A CONTROL RELEASE NEEDLE. ADDITIONAL SUTURE WAS PERFORMED TO COMPLETE THE CASE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24590781 ↗
• MalfunctionFeb 24, 2026Material Separation

  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, THERE WAS ONE PACKAGE WHICH HAD A PRODUCT THE SUTURE AND THE NEEDLE HAD BEEN DETACHED. IT WAS NOT A CONTROL RELEASE NEEDLE. ADDITIONAL SUTURE WAS PERFORMED TO COMPLETE THE CASE. NO SAMPLE WILL BE RETURNED. 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 24432424 ↗
• MalfunctionJan 15, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SWAGE PART OF TWO NEEDLES WERE BROKEN. NO NEEDLE PIECES FELL INTO THE SURGICAL FIELD. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. FURTHER DETAILS ARE NOT PROVIDED FROM THE HP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24080244 ↗
• MalfunctionJan 15, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SWAGE PART OF TWO NEEDLES WERE BROKEN. NO NEEDLE PIECES FELL INTO THE SURGICAL FIELD. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. FURTHER DETAILS ARE NOT PROVIDED FROM THE HP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24080229 ↗
• MalfunctionOct 15, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED BY A SALES REP THAT, DURING AN UNKNOWN SURGERY, THE SUTURE WAS BROKEN WHEN TYING. IT WAS NOT A CONTROL RELEASE NEEDLE. THERE WAS NO EFFECT ON THE PATIENT. 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. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23300471 ↗
• MalfunctionOct 1, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE WAS BROKEN AT THE SWAGE PART DURING SUTURING. IT APPEARS TO HAVE BEEN A SCARRED AREA. WHEN THE NEEDLE WAS BROKEN, THE NEEDLE FRAGMENTS FELL INTO THE SURGICAL FIELD, BUT WERE QUICKLY RETRIEVED WITHOUT BEING LOST IN SIGHT. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. 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 23191252 ↗
• MalfunctionAug 20, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY A SALES REP THAT, DURING AN UNKNOWN SURGERY, Z464H WAS BROKEN SEVERAL TIMES DURING SURGERY. THE BROKEN PART WAS IN THE MIDDLE OF THE SUTURE. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. NO SAMPLE WILL BE RETURNED DUE TO THE PATIENT WITH AN INFECTIOUS DISEASE. 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 22852341 ↗
• MalfunctionAug 20, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY A SALES REP THAT, DURING AN UNKNOWN SURGERY, Z464H WAS BROKEN SEVERAL TIMES DURING SURGERY. THE BROKEN PART WAS IN THE MIDDLE OF THE SUTURE. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. NO SAMPLE WILL BE RETURNED DUE TO THE PATIENT WITH AN INFECTIOUS DISEASE. 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 22852340 ↗
• MalfunctionJul 30, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING AN UNKNOWN SEMI-OPEN SURGERY, WHEN THE NEEDLE PIERCED THE TISSUE DURING DERMAL SUTURE AND IT WAS CHECKING WHERE IT HAD EMERGED, IT WAS CONFIRMED THAT THE TIP OF THE NEEDLE HAD BROKEN. ALTHOUGH THERE HAVE BEEN NO PROBLEMS WITH THE PATIENT CURRENTLY, NO BROKEN PIECES OF THE NEEDLE WERE FOUND ON THE SPOT, AND THEY WERE NOT FOUND TO REMAIN INSIDE THE BODY EVEN BY AN X-RAY. IT WILL BE SENT ONE PRODUCT WITH A BROKEN NEEDLE AND ONE OF THE SAME STANDARDS AS A REFERENCE PRODUCT, FOR A TOTAL OF TWO. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22663313 ↗
• MalfunctionJul 11, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PLASTIC SURGERY ON (B)(6) 2025 AND SUTURE WAS USED. DURING AN UNKNOWN PLASTIC SURGERY, THE SURGEON FELT THAT THE NEEDLE COULD NOT BE PASSED THROUGH THE TISSUE SMOOTHLY DURING USE AND THE SURGEON CHECKED THE TIP VISUALLY, IT WAS CONFIRMED THAT THE TIP OF THE NEEDLE WAS CHIPPED. IT WAS NOT A CONTROL RELEASE NEEDLE. ADDITIONAL SUTURE WAS PERFORMED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22478494 ↗
• MalfunctionJun 30, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. DURING SURGERY, THE NEEDLE AT THE PROXIMAL END WAS BROKEN. IT WAS NOT A CONTROL RELEASE NEEDLE. NO PIECES WERE LEFT INSIDE THE PATIENT. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22361646 ↗
• MalfunctionMay 8, 2025Break; Break

  IT WAS REPORTED BY A SALES REP THAT, DURING AN UNKNOWN RESPIRATORY SURGERY, IN A UROLOGIC CASE, THE NEEDLE WAS BROKEN AT THE SWAGE PART. IN A DA VINCI CASE, THE NEEDLE TIP DID NOT FALL OFF. NO PIECE FELL INTO THE PATIENT. 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. AFFILIATE REFERENCE NUMBER: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21990785 ↗
• MalfunctionJan 21, 2025Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE PRODUCT WAS A SINGLE-ARMED SUTURE OF 4-0, BUT THERE WAS INCLUDED A DOUBLE-ARMED SUTURE IN THE PACKAGE. THE PRODUCT WAS NOT USED FOR THE PATIENT. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21198881 ↗
• MalfunctionJan 15, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HEPATECTOMY PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING A HEPATECTOMY, DURING INTERRUPTING SUTURE, THE SUTURE WAS BROKEN WHEN THE INSTRUMENT TIE WAS PERFORMED IN DERMAL SUTURE. THE PRODUCT WAS USED ON THE DERMIS. IT WAS NOT A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21160983 ↗
• MalfunctionJan 15, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HEPATECTOMY PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING A HEPATECTOMY, DURING INTERRUPTING SUTURE, THE SUTURE WAS BROKEN WHEN THE INSTRUMENT TIE WAS PERFORMED IN DERMAL SUTURE. THE PRODUCT WAS USED ON THE DERMIS. IT WAS NOT A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21160955 ↗
• MalfunctionNov 4, 2024Dull, Blunt; Dull, Blunt

  IT WAS REPORTED FROM THE ANALYSIS OF THE RETURNED PRODUCT THAT NEEDLE BREAKAGE WAS OBSERVED. IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. IT WAS REPORTED WHEN THE PACKAGE WAS OPENED THE NEEDLE TIP WAS NOT SHARP AND COULD NOT BE USED AS A NEEDLE. NO HARM WAS DONE BECAUSE IT WAS BEFORE USE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20599597 ↗
• MalfunctionOct 28, 2024Material Separation; Material Separation

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2024 AND SUTURE WAS USED. THE SUTURE WAS DETACHED FROM THE NEEDLE WHEN THE NEEDLE WAS GRASPED WITH THE NEEDLE-HOLDER AND TAKEN OUT. IT WAS NOT A CONTROL RELEASE NEEDLE. FURTHER DETAILS ARE NOT PROVIDED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20550737 ↗
• MalfunctionSep 13, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED BY A SALES REP THAT, DURING AN UNKNOWN SURGERY, THE NEEDLE WAS BROKEN WHEN THE NEEDLE WAS GRASPED TO USE THE DEVICE. IT WAS NOT A CONTROL RELEASE NEEDLE. FURTHER DETAILS ARE NOT PROVIDED FROM THE HP. ONE SAMPLE WILL BE RETURNED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20212914 ↗
• MalfunctionSep 3, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, WHEN TRIED TO USE THE PRODUCT ON THE DERMIS, THE NEEDLE WAS BROKEN AT THE SWAGE PART. THERE WAS NO EFFECT TO THE PATIENT. IT WAS NOT A CONTROL RELEASE NEEDLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20128774 ↗
• MalfunctionAug 28, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE ARTHROPLASTY PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, SUTURE BREAKAGE OCCURRED. THE PRODUCT WAS USED ON THE DERMIS, AND THE OPERATION TIME WAS NO EXTENSION. IT WAS NOT A CONTROL RELEASE NEEDLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20085350 ↗
• MalfunctionMay 7, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. WHEN TAKING IT OUT FROM THE CASE, THE SUTURE AND NEEDLE WERE COME OFF. IT WAS NOT A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19258871 ↗
• MalfunctionFeb 26, 2024Break; Break

  IT WAS REPORTED THAT PATIENT UNDERWENT A LAPAROSCOPIC CHOLECYSTECTOMY ON AN UNKNOWN DATE, AND SUTURE WAS USED ON THE DERMIS. DURING THE SURGERY, THE SUTURE BROKE DURING USE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18784251 ↗
• MalfunctionFeb 26, 2024Break; Break

  IT WAS REPORTED THAT PATIENT UNDERWENT A LAPAROSCOPIC CHOLECYSTECTOMY ON AN UNKNOWN DATE, AND SUTURE WAS USED. DURING THE SURGERY, THE NEEDLE WAS BROKEN AT THE TIME OF WOUND CLOSURE. THE BROKEN NEEDLE WAS BURIED UNDER SUBCUTANEOUS. THE NEEDLE PIECE WAS VISUALLY CONFIRMED; IT WAS RETRIEVED DIRECTLY. NO X-RAYS WERE TAKEN TO LOCATE THE BROKEN PIECE. THERE WAS NO ADDITIONAL TISSUE DAMAGE AS A RESULT OF SEARCHING FOR THE NEEDLE PIECE. NO ADDITIONAL INCISION WAS MADE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18784196 ↗
• MalfunctionJan 9, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A ORTHOPEDIC PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING AN UNKNOWN ORTHOPEDIC SURGERY, THE SUTURE BROKE DURING USE AT THE TIME OF WOULD CLOSURE. AFTER THAT, THE NEEDLE WAS BROKEN AT THE BODY PART WHEN THE NEEDLE WAS HELD THE SECOND TIME. THESE BOTH THINGS WERE HAPPENED IN THE SAME NEEDLE-SUTURE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18475524 ↗
• MalfunctionJan 9, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A ORTHOPEDIC PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING AN UNKNOWN ORTHOPEDIC SURGERY, THE SUTURE BROKE DURING USE AT THE TIME OF WOULD CLOSURE. AFTER THAT, THE NEEDLE WAS BROKEN AT THE BODY PART WHEN THE NEEDLE WAS HELD THE SECOND TIME. THESE BOTH THINGS WERE HAPPENED IN THE SAME NEEDLE-SUTURE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18475523 ↗