Swartz™ 407356Recalls & reported problems
St. Jude Medical, Inc. · BRAIDED TRANSSEPTAL GUIDING INTRODUCER · Class 2
All models of Swartz (17)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05414734205511), received between Jun 25, 2018 and Apr 22, 2024 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Difficult to Insert” (1 report).
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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Difficult to Insert1
- Flaked1
Patient problems
- Cardiac Perforation1
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 22, 2024Difficult to Insert; Difficult to Insert
THIS REPORT IS TO ADVISE OF A DEVICE PUNCTURE NOTED DURING ANALYSIS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19159871 ↗MalfunctionMar 20, 2019Flaked; Flaked
THIS REPORT IS TO ADVISE OF AN EVENT OF SKIVING OBSERVED DURING ANALYSIS CONFIRMING THE REPORTED INSERTION DIFFICULTY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8436015 ↗InjuryJun 25, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
RELATED MANUFACTURING REFERENCE: 3008452825-2018-00186, 3008452825-2018-00189, 3008452825-2018-00190, 3008452825-2018-00191, 3005334138-2018-00172, 2030404-2018-00046, 3005334138-2018-00173. DURING AN ATRIAL FIBRILLATION ABLATION PROCEDURE A CARDIAC PERFORATION OCCURRED. DURING ROUTINE ECHOCARDIOGRAPHY A SMALL EFFUSION WAS DIAGNOSED. THE PATIENT'S BLOOD PRESSURE WAS STABLE. OCTAPLEX WAS ADMINISTERED TO REVERSE ANTICOAGULANT THERAPY AND THE PATIENT WAS TRANSFERRED TO THE CORONARY CARE UNIT. THE PATIENT RECOVERED AND WAS STABLE.
Patient problems: Cardiac Perforation
MAUDE report 7633487 ↗
Other INTRODUCER, CATHETER devices
- VIZIGO D138502Biosense Webster Inc · INTRODUCER, CATHETER2 recalls4 deaths2,839 reports
- VIZIGO D138501Biosense Webster Inc · INTRODUCER, CATHETER2 recalls2 deaths2,005 reports
- Swartz™ 407451St. Jude Medical, Inc. · INTRODUCER, CATHETER5 deaths728 reports
- Edwards eSheath+ Introducer set 914ESPEdwards Lifesciences LLC · Introducer, Catheter22 deaths532 reports
- Fast-Cath™ 406849St. Jude Medical, Inc. · INTRODUCER, CATHETER420 reports
- VIZIGO D138503Biosense Webster Inc · INTRODUCER, CATHETER362 reports
- Agilis™ G408318St. Jude Medical, Inc. · INTRODUCER, CATHETER333 reports
- Agilis™ NxT Steerable Introducer Dual-Reach™ SI-1371-MSt. Jude Medical, Inc. · Introducer, catheter1 death301 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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