Gould G27437Recalls & reported problems
Cook Incorporated · Gould Catheter Introduction Set with Nitinol Wire Guide · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00827002274372), received between May 4, 2018 and Jan 2, 2025 — classified as 2 injuries.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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
- Detachment of Device or Device Component1
- Material Separation1
Patient problems
- Device Embedded In Tissue or Plaque1
- Foreign Body In Patient1
- Internal Organ Perforation1
- No Consequences Or Impact To Patient1
- Perforation of Vessels1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJan 2, 2025Material Separation; Material Separation
IT WAS REPORTED THAT THE CATHETER FROM A GOULD INTRODUCTION SET BROKE IN A PATIENT'S LIVER. AFTER A DAY, A 5 CM PORTION OF THE CATHETER WAS RETAINED IN THE PATIENT. NO OTHER ADVERSE EFFECTS WERE REPORTED FOR THIS INCIDENT. ADDITIONAL INFORMATION REGARDING EVENT DETAILS AND PATIENT OUTCOME HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THIS TIME.
Patient problems: Foreign Body In Patient; Internal Organ Perforation; Perforation of Vessels
MAUDE report 21059808 ↗InjuryMay 4, 2018Detachment of Device or Device Component; Detachment of Device or Device Component
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: Device Embedded In Tissue or Plaque; No Consequences Or Impact To Patient
MAUDE report 7486136 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page