NA 405112Recalls & reported problems
St. Jude Medical, Inc. · Peel-Away Introducer · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05415067040893), received between Aug 7, 2024 and Mar 30, 2026 — classified as 4 injuries.
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 Problem3
- Appropriate Device Problem Term/Code Not Available1
Patient problems
- Hemorrhage/Blood Loss/Bleeding4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryMar 30, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED VIA CHINA MEDICAL DEVICE AE REPORTING SYSTEM THAT THE PATIENT PRESENTED FOR AN IMPLANT PROCEDURE. DURING THE PROCEDURE, BLEEDING OCCURRED AFTER PLACEMENT OF THE INTRODUCER SHEALTH. THE BLEEDING IMPROVED AFTER COMPRESSION WITH GAUZE. THE PATIENT WAS STABLE.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 24729170 ↗InjuryDec 12, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
REPORT RECEIVED FROM CHINA MEDICAL DEVICE AE REPORTING SYSTEM STATES: ON (B)(6) 2025, THE PATIENT ACCEPTED PACEMAKER IMPLANTATION FOR TYPE II AV BLOCK DEGREE II, PREOPERATIVE PREPARATION WAS NORMAL. DURING THE OPERATION, BLEEDING WAS HIGH AFTER PLACEMENT OF THE PEEL-AWAY INTRODUCER AND COMPROMISED THE PROCEDURE. THE PHYSICIAN GAVE COTTON BALL COMPRESSION TO REDUCE BLEEDING. THE PHYSICIAN THOUGHT THE PEEL-AWAY INTRODUCER HAD POOR SEAL.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 23791585 ↗InjuryOct 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT PRESENTED FOR AN IMPLANT PROCEDURE. AN EXCESSIVE BLEEDING OCCURRED AFTER PLACEMENT OF THE INTRODUCER SHEALTH. COMPRESSION THERAPY WAS GIVEN TO RESOLVE THE EVENT. THE PATIENT WAS STABLE.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 20506112 ↗InjuryAug 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED A PATIENT PRESENTED FOR AN IMPLANT PROCEDURE ON 12 JUL 2024 WHEN THE INTRODUCER SHEATH CAUSED EXCESSIVE BLEEDING. COMPRESSION THERAPY WAS GIVEN TO RESOLVE THE EVENT. POST-PROCEDURE THE PATIENT WAS STABLE.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 19934611 ↗
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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