ATTAIN SELECT™ II 6248DEL90DL02Recalls & reported problems
Medtronic, Inc. · CATHETER 6248DEL90DL02 · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00613994746832), received between Dec 7, 2017 and Dec 7, 2017 — classified as 1 injury.
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 18, 2026.
Most reported problems
Device problems
- Detachment Of Device Component1
Patient problems
- Device Embedded In Tissue or Plaque1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryDec 7, 2017Detachment Of Device Component; Detachment Of Device Component
IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THE DELIVERY AND INNER STRAIGHT CATHETER WERE POSITIONED IN ORDER TO SELECT A VEIN FOR THE LEFT VENTRICULAR (LV) LEAD. WHEN THE PHYSICIAN REMOVED THE INNER CATHETER, THE RADIOPAQUE TIP GOT LOST AND LODGED INTO CORONARY SINUS. THE TIP AT THE TIME REMAINED IN THE LEFT LUNG. THE PATIENT IS BEING OBSERVED AND WILL FOLLOW UP. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 7090336 ↗
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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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