Worley Advanced CSGRecalls & reported problems across all models

We found 4 models of Worley Advanced CSG by Merit Medical Systems, Inc. in the FDA's device registry (GUDID). Together they are named in 3 adverse event reports in the FDA's MAUDE database, received between Apr 4, 2023 and Aug 1, 2023 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Fracture” (3 reports).

1 FDA recall record name at least one of these models by its device 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Worley Advanced CSG recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Jun 11, 2024Open, Classified

   Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

   Z-2577-2024 · Root cause: No Marketing Application · names 4 of these models · Recall details · FDA record ↗

Most reported Worley Advanced CSG problems

Worley Advanced CSG models

4 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Worley Advanced CSG 00884450484487

  INTRODUCER, CATHETER
  1 recall2 reports
• Worley Advanced CSG 00884450484319

  INTRODUCER, CATHETER
  1 recall1 report
• Worley Advanced CSG 00884450484456

  INTRODUCER, CATHETER
  1 recall0 reports
• Worley Advanced CSG 00884450484463

  INTRODUCER, CATHETER
  1 recall0 reports

Recent Worley Advanced CSG adverse event reports

The 3 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionAug 1, 2023Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING AN UPGRADE TO A BIV-ICD PROCEDURE WHEN SPLITTING THE PEEL-AWAY SHEATH, THE RADIOPAQUE MARKER BAND DETACHED AND MIGRATED TO THE PATIENT'S LUNG. THE PHYSICIAN STATES THAT NO UNUSUAL ANATOMY WAS NOTED DURING THE PROCEDURE FOR THIS PATIENT, AND NO HEMODYNAMIC CHANGES DUE TO THE FOREIGN BODY INTRODUCTION WERE NOTED. THE PATIENT IS DOING WELL, THERE ARE NO PLANS TO REMOVE THE FOREIGN BODY FROM THIS PATIENT. ADMISSION TO THE HOSPITAL OR PROLONGATION OF HOSPITALIZATION WAS NOT NECESSARY. NO ADDITIONAL INTERVENTIONS OR MEDICATION WERE NECESSARY.

  Patient problems: Foreign Body In Patient

  MAUDE report 17438374 ↗
• MalfunctionApr 4, 2023Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING AN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) PROCEDURE, THE TIP OF A CORONARY SINUS SHEATH DETACHED WITHIN THE PATIENT. THE FOREIGN BODY WAS REMOVED FROM THE LEAD BY THE PHYSICIANS HAND. NO MEDICAL INTERVENTION NECESSARY. NO PATIENT INJURY OR DELAY IN THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16678971 ↗
• InjuryApr 4, 2023Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING AN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) PROCEDURE, THE TIP OF A CORONARY SINUS SHEATH DETACHED WITHIN THE PATIENT. THE PHYSICIAN LEFT THE TIP WITHIN THE PATIENT'S CORONARY SINUS [CS]. A PARTIAL DEVICE IS RETURNING FOR EVALUATION.

  Patient problems: Foreign Body In Patient

  MAUDE report 16678969 ↗

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