PDS ZB740Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 10705031062108), received between May 8, 2018 and Jan 31, 2025 — classified as 4 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Break” (9 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 31, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2025 AND SUTURE WAS USED. THE NEEDLE AND SUTURE HAD COME OFF DURING USE IN FASCIA SUTURING OF THE WOUND CLOSURE. IT WAS A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21287573 ↗
• MalfunctionAug 14, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. WHEN OPENED THE PACKAGE, THERE WAS A BROWN TRASH IN IT. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19987311 ↗
• MalfunctionMar 26, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A COLECTOMY PROCEDURE ON (B)(6) 2024, AND SUTURE WAS USED. DURING INTERRUPTED SUTURING, THE SUTURE WAS DETACHED FROM THE NEEDLE ALTHOUGH NO EXTRA FORCE WAS APPLIED ON THE PART OF CR. IT OCCURRED IN ONE OF THE PRODUCT IN EACH TWO PACKAGES. IT WAS A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18977952 ↗
• MalfunctionMar 26, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A COLECTOMY PROCEDURE ON (B)(6) 2024, AND SUTURE WAS USED. DURING INTERRUPTED SUTURING, THE SUTURE WAS DETACHED FROM THE NEEDLE ALTHOUGH NO EXTRA FORCE WAS APPLIED ON THE PART OF CR. IT OCCURRED IN ONE OF THE PRODUCT IN EACH TWO PACKAGES. IT WAS A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18977948 ↗
• MalfunctionAug 11, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS FOUND THAT THE SUTURE WAS DETACHED FROM THE NEEDLE. IT WAS 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 17511780 ↗
• MalfunctionMay 26, 2023Device 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. AFTER OPENING THE PACKAGE AND BEFORE USE, IT WAS CONFIRMED THAT A FOREIGN SUBSTANCE OF BIOLOGICAL ORIGIN, SUCH AS HUMAN HAIR OR INSECT, WAS FOUND IN THE STERILE PACKAGE. THE OPERATION TIME WAS EXTENDED WITHIN 30 MINUTES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17009629 ↗
• MalfunctionJul 28, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, WHEN TAKING OUT FROM THE PACKAGE, IT WAS FOUND THAT THE NEEDLE TIP HAD BEEN MISSING. THE NEEDLE TIP WAS SEARCHED, BUT IT COULD NOT BE FOUND, SO IT WAS COMMENTED THAT IT MAY HAVE BEEN IN THIS STATE FROM THE BEGINNING. THE NEEDLE TIP DID NOT FALL INTO THE PATIENT. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12240083 ↗
• MalfunctionJan 6, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2020 AND THE SUTURE WAS USED. DURING SURGERY, AFTER OPENING THE PACKAGE, THE NEEDLE WAS BROKEN IMMEDIATELY WHEN HOLDING THE NEEDLE. THE SUTURE BROKE BEFORE USE ON THE PATIENT. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11128214 ↗
• MalfunctionJul 1, 2020Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2020 AND SUTURE WAS USED. DURING WOUND CLOSURE BY INTERRUPTED SUTURING, AFTER PASSING THE NEEDLE THROUGH THE ABDOMINAL FASCIA, WHEN TRYING TO TIE A KNOT, THE SUTURE WAS BROKEN EASILY. ANOTHER PACKAGE WAS USED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10217489 ↗
• MalfunctionJul 1, 2020Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2020 AND SUTURE WAS USED. DURING WOUND CLOSURE BY INTERRUPTED SUTURING, AFTER PASSING THE NEEDLE THROUGH THE ABDOMINAL FASCIA, WHEN TRYING TO TIE A KNOT, THE SUTURE WAS BROKEN EASILY. ANOTHER PACKAGE WAS USED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10217484 ↗
• MalfunctionJul 1, 2020Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2020 AND SUTURE WAS USED. DURING WOUND CLOSURE BY INTERRUPTED SUTURING, AFTER PASSING THE NEEDLE THROUGH THE ABDOMINAL FASCIA, WHEN TRYING TO TIE A KNOT, THE SUTURE WAS BROKEN EASILY. ANOTHER PACKAGE WAS USED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10217483 ↗
• MalfunctionMay 14, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2020 AND THE SUTURE WAS USED. IT WAS REPORTED THAT WHEN TRYING TO USE THE PRODUCTS, IT WAS FOUND THAT SOME SUTURES HAD BEEN DETACHED FROM THE NEEDLES. THEY WERE CONTROL RELEASE NEEDLES. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10060031 ↗
• InjuryFeb 26, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN OB-GYN SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE LONGITUDINAL INCISION WAS MADE NOT EXACTLY ON THE MIDLINE (LINEA ALBA) BUT WAS SLIGHTLY APART FROM THE MIDLINE. THE BOTH ENDS OF THE LONGITUDINAL INCISION WERE SUTURED BY INTERRUPTED SUTURING, AND THE MIDDLE OF THE INCISION WAS SUTURED BY CONTINUOUS SUTURING. ABOUT ONE WEEK AFTER THE PROCEDURE, WOUND DEHISCENCE OCCURRED IN THE WARD ON THE FASCIA. IT WAS REPORTED THAT CONTRIBUTING FACTORS WERE THE PATIENT WAS OBESE WITH BMI 30. IT WAS ALSO REPORTED THAT CONTRIBUTING FACTORS WERE TENSION WAS APPLIED TO A PART OF THE SUTURE AND DELAYED HEALING AT THE INCISION SITE. NO SUTURE BREAKAGE OCCURRED AND THE FASCIA WAS BROKEN AND TORN. DURING THE REOPERATION, IT WAS CONFIRMED THAT THE SUTURE REMAINED ON ONE SIDE OF THE INCISION. THE WOUND OPENING WAS NOT EXACTLY ON THE MIDLINE (LINEA ALBA) BUT WAS SLIGHTLY APART FROM THE MIDLINE. THE WOUND ON THE PERITONEUM AND THE WOUND ON THE FASCIA WERE SUTURED INDIVIDUALLY BY INTERRUPTED SUTURING. FOR REINFORCEMENT OF THE CLOSURE THE MIDDLE PART, EXCEPT FOR BOTH ENDS OF THE WOUND ON THE FASCIA, WAS SUTURED BY CONTINUOUS SU

  Patient problems: Impaired Healing; No Code Available; Wound Dehiscence

  MAUDE report 9752985 ↗
• MalfunctionSep 6, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. WHEN THE SURGEON WAS HOLDING THE NEEDLE BY A NEEDLE-HOLDER, THE NEEDLE WAS BROKEN AT THE BODY PART. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8972656 ↗
• MalfunctionFeb 22, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT LAPAROSCOPY-ASSISTED DISTAL GASTRECTOMY ON (B)(6) 2019 AND SUTURE WAS USED. WHEN CLOSING WOUND OF SMALL INCISION SITE, ONE OF THE NEEDLES WAS DETACHED FROM THE SUTURE EASILY DURING PASSING THE NEEDLE THROUGH THE FASCIA BY INTERRUPTED SUTURING. IT WAS A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8363844 ↗
• InjuryMay 8, 2018Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT OPEN TOTAL GASTRECTOMY PROCEDURE ON (B)(6) 2018 AND SUTURE WAS USED TO CLOSE THE WOUND ON FASCIA WITH INTERRUPTED TECHNIQUE. POST OPERATIVELY, THE PATIENT COUGHED IN THE WARD. A SECOND PROCEDURE WAS PERFORMED ON (B)(6) 2018 AND SUTURE WAS FOUND BROKEN, THE TISSUE WAS NOT CUT WHEN WOUND DEHISCED. THE SURGEON OPINED THAT STRONG FORCE WAS APPLIED TO THE SUTURE DURING BUCKING SINCE THE PATIENT WAS OBESE. THE PATIENT IS REPORTED AS STABLE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Code Available; Wound Dehiscence

  MAUDE report 7495956 ↗
• InjuryMay 8, 2018Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT OPEN TOTAL GASTRECTOMY PROCEDURE ON (B)(6) 2018 AND SUTURE WAS USED TO CLOSE THE WOUND ON FASCIA WITH INTERRUPTED TECHNIQUE. POST OPERATIVELY, THE PATIENT COUGHED IN THE WARD. A SECOND PROCEDURE WAS PERFORMED ON (B)(6) 2018 AND SUTURE WAS FOUND BROKEN, THE TISSUE WAS NOT CUT WHEN WOUND DEHISCED. THE SURGEON OPINED THAT STRONG FORCE WAS APPLIED TO THE SUTURE DURING BUCKING SINCE THE PATIENT WAS OBESE. THE PATIENT IS REPORTED AS STABLE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Code Available; Wound Dehiscence

  MAUDE report 7495910 ↗
• InjuryMay 8, 2018Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT OPEN TOTAL GASTRECTOMY PROCEDURE ON 4/16/2018 AND SUTURE WAS USED TO CLOSE THE WOUND ON FASCIA WITH INTERRUPTED TECHNIQUE. POST OPERATIVELY, THE PATIENT COUGHED IN THE WARD. A SECOND PROCEDURE WAS PERFORMED ON (B)(6) 2018 AND SUTURE WAS FOUND BROKEN, THE TISSUE WAS NOT CUT WHEN WOUND DEHISCED. THE SURGEON OPINED THAT STRONG FORCE WAS APPLIED TO THE SUTURE DURING BUCKING SINCE THE PATIENT WAS OBESE. THE PATIENT IS REPORTED AS STABLE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Code Available; Wound Dehiscence

  MAUDE report 7495845 ↗