FlexCath™ Select 990065Recalls & reported problems
Medtronic, Inc. · SHEATH 990065 FLEXCATH SELECT 10 FR 65CM · Class 2
Data updated Oct 16, 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 00643169688858), received between Aug 22, 2019 and Aug 26, 2019 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Material Deformation” (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 16, 2026.
Most reported problems
Device problems
- Material Deformation2
- Material Twisted/Bent1
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.
MalfunctionAug 26, 2019Material Deformation; Material Deformation
IT WAS REPORTED THAT DURING A RADIOFREQUENCY (RF) PROCEDURE, THE SHEATH WAS HAVING DIFFICULTY MANEUVERING. IT WAS THEN OBSERVED THE SHEATH WAS KINKED AND WAS REPLACED. THE SECOND SHEATH ALSO HAD MANEUVERABILITY ISSUES AND WAS ABLE TO BE MANIPULATED WITH RESOLVE IN ORDER TO PERFORM RF. THE CASE WAS COMPLETED WITH RADIOFREQUENCY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. THE SECOND SHEATH SUBSEQUENTLY TESTED OUT OF SPECIFICATION PER THE MANUFACTURER'S INVESTIGATION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8933550 ↗MalfunctionAug 22, 2019Material Deformation; Material Twisted/Bent; Material Deformation; Material Twisted/Bent
IT WAS REPORTED THAT DURING A RADIOFREQUENCY (RF) PROCEDURE, THE SHEATH WAS HAVING DIFFICULTY MANEUVERING. IT WAS THEN OBSERVED THE SHEATH WAS KINKED AND WAS REPLACED. THE SECOND SHEATH ALSO HAD MANEUVERABILITY ISSUES AND WAS ABLE TO BE MANIPULATED WITH RESOLVE IN ORDER TO PERFORM RF. THE CASE WAS COMPLETED WITH RADIOFREQUENCY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8922486 ↗
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