PTFE Peelable Introducer Kit 667093-303Recalls & reported problems
Greatbatch Ltd · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00802526527852), received between Aug 15, 2016 and Aug 15, 2016 — classified as 1 injury.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 18, 2026.
Most reported problems
Device problems
- Insufficient Device Problem Information1
Patient problems
- Bradycardia1
- Cardiac Arrest1
- Ventricular Tachycardia1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 15, 2016Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT DURING AN IMPLANT OF A CRTD DURING THE FIRST VENIPUNCTURE, THE PATIENT BECOMES BRADYCARDIC (FC: 25 LPM) AND HYPOTENSIVE (PAI: 40/20), WHICH IMPROVES WITH ADRENALINE AND ATROPINE. THE PROCEDURE CONTINUES, DR. (B)(6) ADVANCES A LEFT VENTRICULAR LEAD: MODEL: 0296/367061 AND A LEFT ATRIAL LEAD: MODEL: 7741/658410. THE PATIENT DEVELOPS VENTRICULAR TACHYCARDIA (VT), WHICH THE PHYSICIAN DEFIBRILLATES 200J. THEN THE PATIENT BECOMES IN PULSELESS ELECTRICAL ACTIVITY AND ASYSTOLE. THE PHYSICIAN THEN PERFORMS BASIC AND ADVANCED MANEUVERS (RESUSCITATION). THE PATIENT REMAINS HOSPITALIZED IN ICU. A SECOND PROCEDURE WAS PERFORMED (B)(6) 2016 TO IMPLANT THE DEVICE AND LV LEAD, WITH NO FURTHER ADVERSE EFFECTS REPORTED.
Patient problems: Bradycardia; Cardiac Arrest; Ventricular Tachycardia
MAUDE report 5877790 ↗
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- 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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