Attain Select™ II + SureValve™ 6248V-90SP (UDI 00643169184176)Recalls & reported problems
Medtronic, Inc. · Catheter 6248V-90SP Attain Select II · Class 2
All models of Attain Select II + SureValve (15)
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 00643169184176), received between Jun 8, 2017 and Mar 6, 2019 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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
- Detachment of Device or Device Component2
- Break1
- Material Integrity 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.
MalfunctionMar 6, 2019Detachment of Device or Device Component; Material Integrity Problem; Detachment of Device or Device Component; Material Integrity Problem
IT WAS REPORTED THAT THE DELIVERY CATHETER BROKE WHILE SLITTING. AFTER HAVING SLIT THE LEAD, A SIGNIFICANT PORTION OF THE INNER CATHETER WAS STILL ON THE LEAD. THE PHYSICIAN WAS ABLE TO GRASP A PORTION OF THE REMAINING CATHETER WITH A HEMOSTAT AND SLIT, AGAIN WITH DIFFICULTY, THE REMAINING INNER CATHETER FROM THE LEAD. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8395427 ↗MalfunctionJun 8, 2017Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE DURING SPLITTING, THE CATHETER TORE AND SEPARATED IN THE TRANSITION ZONE DISTAL TO THE HUB. THE HUB AND PROXIMAL END OF THE CATHETER SEPARATED FROM THE REST OF THE CATHETER. THE PHYSICIAN WAS ABLE TO REMOVE THE SHEATH BY CUTTING AND PULLING IT BACK CAREFULLY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6627441 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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