PDS PDP304HRecalls & reported problems

Summary

The FDA's MAUDE database contains 61 adverse event reports that list this exact device (DI 10705031047976), received between Dec 20, 2017 and Sep 29, 2026 — classified as 12 injuries, 49 malfunctions.

The most frequently reported specific device problem is “Break” (35 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. May 10, 2024Open, Classified

   Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .

   Z-2147-2024 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 61 reports, in the reporter's own words as published by the FDA.

• InjurySep 29, 2026Break

  Patient problems: Foreign Body In Patient

  MAUDE report 50937774 ↗
• MalfunctionJun 23, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2026, AND SUTURE WAS USED. IT WAS REPORTED THAT THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED IN THE SURGERY. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE IS NO REPORT ON PATIENT'S INJURY. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25594207 ↗
• MalfunctionJun 18, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING SURGERY (WHEN TAKING OUT THE PACKAGING), WHEN USING SUTURES, NEEDLE-THREAD SEPARATION. THERE WERE NO PATIENT CONSEQUENCES REPORTED. THERE WAS NO SURGICAL DELAY REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25550069 ↗
• InjuryJan 12, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A COMMON BILE DUCT INCISION AND STONE REMOVAL SURGERY/CHOLEDOCHOLITHOTOMY SURGERY ON (B)(6) 2025 AND SUTURE WAS USED TO SEW THE BILE DUCT INCISION. SEVEN TO EIGHT DAYS POST-OP, THE PATIENT WAS FOUND TO HAVE A BILE DUCT LEAK COMPLICATION. A SECOND SURGERY WAS DONE AND IT FOUND THE PREVIOUS SUTURE WAS ALREADY DEGRADED ABOUT 70-80%, THE SUTURE ON THE BILE DUCT INCISION WAS BROKEN, AND ONLY A SMALL SUTURE TIE WAS LEFT. THE INCISION WAS RE-SUTURED. THE CURRENT CONDITION OF THE PATIENT WAS REPORTED AS STABLE. THE SURGEON OPINED IT WAS RELATED TO THE PRODUCT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Discomfort; Failure to Anastomose; Insufficient Information

  MAUDE report 24036108 ↗
• InjuryJan 12, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A COMMON BILE DUCT INCISION AND STONE REMOVAL SURGERY/CHOLEDOCHOLITHOTOMY SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED TO SEW THE BILE DUCT INCISION. SEVEN TO EIGHT DAYS POST-OP, THE PATIENT WAS FOUND TO HAVE A BILE DUCT LEAK COMPLICATION. A SECOND SURGERY WAS DONE AND IT FOUND THE PREVIOUS SUTURE WAS ALREADY DEGRADED ABOUT 70-80%, THE SUTURE ON THE BILE DUCT INCISION WAS BROKEN, AND ONLY A SMALL SUTURE TIE WAS LEFT. THE INCISION WAS RE-SUTURED. THE CURRENT CONDITION OF THE PATIENT WAS REPORTED AS STABLE. THE SURGEON OPINED IT WAS RELATED TO THE PRODUCT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Discomfort; Failure to Anastomose; Insufficient Information

  MAUDE report 24036091 ↗
• InjuryJan 12, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A COMMON BILE DUCT INCISION AND STONE REMOVAL SURGERY/CHOLEDOCHOLITHOTOMY SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED TO SEW THE BILE DUCT INCISION. SEVEN TO EIGHT DAYS POST-OPERATION, THE PATIENT WAS FOUND TO HAVE A BILE DUCT LEAK COMPLICATION. A SECOND SURGERY WAS DONE AND IT FOUND THE PREVIOUS SUTURE WAS ALREADY DEGRADED ABOUT 70-80%, THE SUTURE ON THE BILE DUCT INCISION WAS BROKEN, AND ONLY A SMALL SUTURE TIE WAS LEFT. THE INCISION WAS RE-SUTURED. THE CURRENT CONDITION OF THE PATIENT WAS REPORTED AS STABLE. THE SURGEON OPINED IT WAS RELATED TO THE PRODUCT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Discomfort; Failure to Anastomose; Insufficient Information

  MAUDE report 24035969 ↗
• InjuryJan 12, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A COMMON BILE DUCT INCISION AND STONE REMOVAL SURGERY/CHOLEDOCHOLITHOTOMY SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED TO SEW THE BILE DUCT INCISION. SEVEN TO EIGHT DAYS POST-OP, THE PATIENT WAS FOUND TO HAVE A BILE DUCT LEAK COMPLICATION. A SECOND SURGERY WAS DONE AND IT FOUND THE PREVIOUS SUTURE WAS ALREADY DEGRADED ABOUT 70-80%, THE SUTURE ON THE BILE DUCT INCISION WAS BROKEN, AND ONLY A SMALL SUTURE TIE WAS LEFT. THE INCISION WAS RE-SUTURED. THE CURRENT CONDITION OF THE PATIENT WAS REPORTED AS STABLE. THE SURGEON OPINED IT WAS RELATED TO THE PRODUCT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Discomfort; Failure to Anastomose; Insufficient Information

  MAUDE report 24035804 ↗
• InjuryJan 12, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A COMMON BILE DUCT INCISION AND STONE REMOVAL SURGERY/CHOLEDOCHOLITHOTOMY SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED TO SEW THE BILE DUCT INCISION. SEVEN TO EIGHT DAYS POST-OP, THE PATIENT WAS FOUND TO HAVE A BILE DUCT LEAK COMPLICATION. A SECOND SURGERY WAS DONE AND IT FOUND THE PREVIOUS SUTURE WAS ALREADY DEGRADED ABOUT 70-80%, THE SUTURE ON THE BILE DUCT INCISION WAS BROKEN, AND ONLY A SMALL SUTURE TIE WAS LEFT. THE INCISION WAS RE-SUTURED. THE CURRENT CONDITION OF THE PATIENT WAS REPORTED AS STABLE. THE SURGEON OPINED IT WAS RELATED TO THE PRODUCT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Discomfort; Failure to Anastomose; Insufficient Information

  MAUDE report 24035800 ↗
• MalfunctionDec 22, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A FOOT AND ANKLE PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED IN FOOT AND ANKLE SURGERY. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE IS NO REPORT ON PATIENT'S INJURY. NO ADDITIONAL INFORMATION COULD BE PROVIDED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23867433 ↗
• MalfunctionJul 23, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ANAL ATRESIA PROCEDURE IN (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO SEW THE TISSUE. 3 PRODUCTS HAVE SAME ISSUE. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO PATIENT CONSEQUENCE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22575625 ↗
• MalfunctionJul 23, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ANAL ATRESIA PROCEDURE IN (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO SEW THE TISSUE. 3 PRODUCTS HAVE SAME ISSUE. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO PATIENT CONSEQUENCE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22575623 ↗
• MalfunctionJul 23, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ANAL ATRESIA PROCEDURE IN (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO SEW THE TISSUE. 3 PRODUCTS HAVE SAME ISSUE. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO PATIENT CONSEQUENCE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22575621 ↗
• MalfunctionFeb 21, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC CHOLECYSTECTOMY ON (B)(6) 2024 AND SUTURE WAS USED. DURING CONTINUOUS SUTURING, IT WAS FOUND THAT THE NEEDLE WAS ALREADY UNUSUALLY BENT AT THE PROXIMAL END WHEN THE PACKAGE WAS OPENED AND GRASPED IT TO USE. IT WAS NOT USED IN SURGERY AND NO PROBLEMS. THE PRODUCT WAS USED ON THE ABDOMINAL CAVITY REINFORCEMENT SUTURE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ANALYSIS OF RETURNED PRODUCT NOTED ONE NEEDLE WAS FOUND BENT AND BROKEN AT THE SWAGE AREA. BESIDES THAT MARKS THAT APPEAR TO BE BY A SURGICAL INSTRUMENT COULD BE OBSERVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21438546 ↗
• MalfunctionFeb 21, 2025Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE NEEDLE WAS DETACHED EASILY. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. NO SAMPLE WILL BE RETURNED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. FURTHER DETAILS ARE NOT PROVIDED. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21434543 ↗
• MalfunctionFeb 21, 2025Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE NEEDLE WAS DETACHED EASILY. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. NO SAMPLE WILL BE RETURNED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. FURTHER DETAILS ARE NOT PROVIDED. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21434542 ↗
• MalfunctionJan 16, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN ORTHOPEDIC PROCEDURE ON AN UNKNOWN DATE AND A SUTURE WAS USED. THE CONNECTION PART OF THE SUTURE AND NEEDLE (THE SWAGE PART) WAS BROKEN DURING USE. 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 21172011 ↗
• MalfunctionNov 11, 2024Break; Defective Component; Break; Defective Component

  IT WAS REPORTED THAT A PATIENT UNDERWENT A MAMMECTOMY PROCEDURE ON AN UNKNOWN DATE AND A SUTURE DEVICE WAS USED. THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO TIE A KNOT WITH SUTURE. BESIDES, THE SUTURE AT THE NEEDLE SUTURE CONNECTION WAS ROUGH. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20658165 ↗
• MalfunctionNov 6, 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. IT WAS REPORTED THAT IT WAS FOUND THAT THERE HAD BEEN FOREIGN MATTER IN THE NEWLY DISPENSED NEEDLE DURING THE SURGERY. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20623456 ↗
• MalfunctionSep 18, 2024Device 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 FOUND THAT THERE HAD BEEN FOREIGN MATTER ON THE PRODUCT IMMEDIATELY ONCE OPENED THE PACKAGE WHEN PREPARING FOR SURGERY. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20249745 ↗
• MalfunctionAug 12, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN OB-GYN SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE WAS BROKEN. IT WAS NOT A CONTROL RELEASE NEEDLE. THE OPERATION TIME WAS EXTENDED WITHIN 30 MINUTES. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19966651 ↗
• MalfunctionAug 9, 2024Material Separation; Defective Component; Material Separation; Defective Component

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE SALES REP THAT OVER THE LAST FEW WEEKS DURING AN UNKNOWN NUMBER OF PROCEDURES, THE NEEDLES ARE POPPING OFF TOO EASILY AND THAT THERE IS TOO MUCH MEMORY IN THE SUTURE LINE. WITH THE WEAK NEEDLES THEY'LL GO TO TUG THE SUTURE OUT OF THE PACKAGE AND THERE IS BREAKAGE. STERILE SAMPLES WILL BE RETURNED. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19955660 ↗
• MalfunctionAug 9, 2024Material Separation; Defective Component; Material Separation; Defective Component

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE SALES REP THAT OVER THE LAST FEW WEEKS DURING AN UNKNOWN NUMBER OF PROCEDURES, THE NEEDLES ARE POPPING OFF TOO EASILY AND THAT THERE IS TOO MUCH MEMORY IN THE SUTURE LINE. WITH THE WEAK NEEDLES THEY'LL GO TO TUG THE SUTURE OUT OF THE PACKAGE AND THERE IS BREAKAGE. STERILE SAMPLES WILL BE RETURNED. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19955512 ↗
• MalfunctionJun 18, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO SEW THE TISSUE. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19559847 ↗
• MalfunctionJan 16, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A RESPIRATORY PROCEDURE ON AN UNKNOWN DATE, AND SUTURE WAS USED. THE SUTURE WAS DETACHED FROM THE NEEDLE. THIS HAPPENED IN 2 PRODUCTS. THESE WERE NOT CONTROL RELEASE NEEDLES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18521892 ↗
• MalfunctionJan 16, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A RESPIRATORY PROCEDURE ON AN UNKNOWN DATE, AND SUTURE WAS USED. THE SUTURE WAS DETACHED FROM THE NEEDLE. THIS HAPPENED IN 2 PRODUCTS. THESE WERE NOT CONTROL RELEASE NEEDLES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18521819 ↗