PTFE Peelable Introducer Kit 667091-303Recalls & reported problems
Greatbatch Ltd · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00802526527845), received between Nov 20, 2017 and Nov 20, 2017 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Device Issue” (2 reports).
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
- Device Issue2
Patient problems
- No Known Impact Or Consequence To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 20, 2017Device Issue; Device Issue
AS REPORTED: DURING A PACEMAKER IMPLANT, THE DOCTOR OPENED AN 8F INTRODUCER AND SAW THAT THE SHEATH WAS BROKEN FROM THE FACTORY. THE INTRODUCER WAS NOT USED. THIS IS THE SAME EVENT AS MDR 2183787-2017-00123.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7045060 ↗MalfunctionNov 20, 2017Device Issue; Device Issue
AS REPORTED: DURING A PACEMAKER IMPLANT, THE DOCTOR OPENED AN 8F INTRODUCER AND SAW THAT THE SHEATH WAS BROKEN FROM THE FACTORY. THE INTRODUCER WAS NOT USED. THIS IS THE SAME EVENT AS MDR 2183787-2017-00122.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7045058 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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