ATTAIN SELECT™ II 6248130D02Recalls & reported problems
Medtronic, Inc. · CATH 6248130D02 ATTAIN GUIDE 4FR LFT H · 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 00613994746610), received between Jun 8, 2017 and Apr 25, 2018 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Detachment Of 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.
Most reported problems
Device problems
- Detachment Of Device Component1
- Mechanical Problem1
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.
MalfunctionApr 25, 2018Mechanical Problem; Mechanical Problem
IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THE DELIVERY CATHETER WAS UNABLE TO BE CUT OPEN. THE DELIVERY CATHETER WAS REMOVED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7461257 ↗MalfunctionJun 8, 2017Detachment Of Device Component; Detachment Of Device Component
IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, WHEN DELIVERING THE CATHETER, THE TIP OF THE CATHETER FRACTURED AND FELL INTO THE VESSEL. THE CATHETER AND TIP WERE CAUGHT WITH A GUIDEWIRE AND REMOVED FROM THE PATIENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6627079 ↗
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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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