PDS PDPB750DRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10705031218833), received between Dec 25, 2019 and May 30, 2025 — classified as 2 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Material Separation” (5 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 30, 2025Material Separation; Material Separation

  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 SUTURE WAS DETACHED FROM THE NEEDLE WHEN A SCRUB NURSE TOOK OUT THE NEEDLE FROM THE TRAY. THE FIRST AND SECOND ONE COULD BE USED NORMALLY BUT THE THIRD SUTURE WAS DETACHED FROM THE NEEDLE EASILY. THIS EVENT WAS FOUND BEFORE USE. IT WAS A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. UPON RETURN OF THE DEVICE, AFTER INVESTIGATION OF THE DETACHED NEEDLE AND SUTURE, SHORT INSERTION WAS OBSERVED IN THE STRAND. THE VISUAL INSPECTION CONCLUDED THAT THE COMBINATION OF THE NEEDLE/SUTURE WAS DETACHED FROM THE NEEDLE SINCE THE INSERTION END OF THE SUTURE DID NOT MEET THE REQUIREMENT. IN ADDITION, SEVEN NEEDLE-SUTURE COMBINATIONS WERE VISUALLY INSPECTED, AND NO ANOMALIES OR ISSUES RELATED TO PULL-OFF WERE OBSERVED DURING THE EVALUATION. AS THE SUTURE IS ABSORBABLE AND THE DURATION OF EXPOSURE OF THE SUTURE IN THE ENVIRONMENT COULD NOT BE DETERMINED, THE FUNCTIONAL TEST COULD NOT BE PERFORMED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22114873 ↗
• MalfunctionJul 23, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIOVASCULAR PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SUTURE CAME OFF WITH A SLIGHT TOUCH DURING USE. THE OPERATION TIME WAS EXTENDED WITHIN 30 MINUTES. IT WAS A CONTROL RELEASE NEEDLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19808938 ↗
• MalfunctionJun 28, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURE HAD BEEN DETACHED. IT WAS A CONTROL RELEASE NEEDLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19638039 ↗
• InjuryAug 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A DAVINCI GASTRECTOMY PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED FOR SUTURING ON FASCIA. AFTER THAT TENSION WAS APPLIED TO THE WOUND, AND THE WOUND OPENED. WOUND DEHISCENCE OCCURRED TWO DAYS AFTER THE SURGERY. REOPERATION WAS PERFORMED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 15284993 ↗
• InjuryAug 22, 2022Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PANCREATICODUODENECTOMY ON AN UNKNOWN DATE AND SUTURE WAS USED ON THE FASCIA. TWO DAYS POST-OP, WHEN THE PATIENT COUGHED, THE ABDOMINAL WALL OPENED. WOUND DEHISCENCE OCCURRED. AN EMERGENCY REOPERATION WAS PERFORMED. THE SURGEON OPINED THAT THE SUTURE WAS NOT THE CAUSE. IT WAS REPORTED THAT THE SUTURE MIGHT HAVE LOOSENED DURING SUTURING. IT WAS STATED THAT BECAUSE THE SUTURE WAS UNTIED, THE SURGEON THINKS THAT THE SUTURE METHOD WAS NOT APPROPRIATE. CURRENT STATUS OF THE PATIENT WAS REPORTED AS IN THE HOSPITAL. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 15272262 ↗
• MalfunctionDec 10, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. WHEN CLOSING THE SURGICAL WOUND, A NURSE NOTICED THAT THE NEEDLE HAD BEEN BROKEN AT THE BODY PART BEFORE USE. NO PART OF THE DEVICE FELL INTO THE PATIENT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12975856 ↗
• MalfunctionApr 21, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SIGMOIDECTOMY PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, ON THE ABDOMINAL FASCIA BY INTERRUPTED SUTURING, THE SUTURE WAS DETACHED FROM THE NEEDLE EASILY. IT WAS A CONTROL RELEASE NEEDLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11701118 ↗
• MalfunctionDec 25, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN ORTHOPEDIC SURGERY ON (B)(6) 2019 AND THE SUTURE WAS USED. IT WAS REPORTED THAT DURING SURGERY, THE NEEDLE EASILY DETACHED FROM THE SUTURE DURING USE. IT WAS A CONTROL RELEASE NEEDLE. THE SURGEON STOPPED USING THE REST OF NEEDLES IN THE PACKAGE, AND ANOTHER PACKAGE WAS USED FOR THE PATIENT. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9517961 ↗