SafeSheath CSGRecalls & reported problems across all models

We found 5 models of SafeSheath 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 Nov 24, 2020 and Feb 15, 2023 — classified as 3 injuries.

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

2 FDA recall records name at least one of these models by its device identifier, 2 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

SafeSheath 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 · Recall details · FDA record ↗

2. 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-2571-2024 · Root cause: No Marketing Application · names 3 of these models · Recall details · FDA record ↗

Most reported SafeSheath CSG problems

SafeSheath CSG models

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

• SafeSheath CSG 00884450484340

  INTRODUCER, CATHETER
  1 recall2 reports
• SafeSheath CSG 00884450484326

  INTRODUCER, CATHETER
  1 recall0 reports
• SafeSheath CSG 00884450484357

  INTRODUCER, CATHETER
  1 recall0 reports
• SafeSheath CSG 00884450484418

  INTRODUCER, CATHETER
  1 recall0 reports
• SafeSheath CSG 00884450484388

  INTRODUCER, CATHETER
  1 report

Recent SafeSheath CSG adverse event reports

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

• InjuryFeb 15, 2023Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT CORONARY SINUS GUIDE BROKE WITHIN THE PATIENT. DURING ACCESS AT THE AXILLARY, THE TIP DETACHED AND THE DEVICE WAS NOT ABLE TO BE REMOVED FROM THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 16383885 ↗
• InjuryFeb 15, 2023Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT CORONARY SINUS GUIDE BROKE WITHIN THE PATIENT. DURING ACCESS AT THE AXILLARY, THE TIP DETACHED AND THE DEVICE WAS REMOVED BY HAND. NO PATIENT INJURY TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16383884 ↗
• InjuryNov 24, 2020Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A BIVENTRICULAR PACEMAKER [BIV-ICD] IMPLANT, THE MARKER BAND OF THE DEVICE DETACHED. THE STAFF STATES THAT THE BAND IS TOO SMALL TO REMOVE WITH A SNARE. NO ATTEMPTS TO RETRIEVE THE FOREIGN BODY WERE MADE.

  Patient problems: Foreign Body In Patient

  MAUDE report 10897341 ↗

Other Merit Medical Systems, Inc. products

• Aspira11 models · 36 reports · 10 recalls
• Impress145 models · 481 reports
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• Bridge Prep Kit4 models · 6 reports · 3 recalls
• Prelude Roadster33 models · 1 reports · 3 recalls
• basixTOUCH6 models · 1 reports · 3 recalls
• basixCOMPAK34 models · 34 reports · 2 recalls
• Flex-Neck11 models · 21 reports · 2 recalls