Attain Select™ II + SureValve™ 6248V-90L (UDI 00763000160555)Recalls & reported problems
Medtronic, Inc. · CATHETER 6248V-90L 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000160555), received between Jun 28, 2022 and Sep 20, 2022 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Break” (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 18, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Break1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- 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.
MalfunctionSep 20, 2022Break; Break
IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, WHEN LOADING THE INTRODUCER INTO THE SHEATH, ¿IT SPLIT LONG SHEATH IN HALF WHILE LOADING IT¿. THE CATHETER WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15457395 ↗InjuryJun 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT DURING IMPLANT, THE PHYSICIAN PERFORATED THE CORONARY SINUS WITH THE CATHETER. THE IMPLANT WAS STOPPED AND THE PATIENT WAS BROUGHT TO SURGERY IN THE OPERATING ROOM TO REPAIR THE CORONARY SINUS. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: Perforation of Vessels
MAUDE report 14846639 ↗
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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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