SiteSeer™ 6A0082Recalls & reported problems
Medtronic, Inc. · CATHETER 6A0082 SS 5PK 6F JL 4.5 100 CM · Class 2
Data updated Oct 16, 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 00613994939753), received between Jun 28, 2021 and Jun 28, 2021 — classified as 1 injury.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).
1 other recall cover devices cleared under the same FDA submission (K932092); they may or may not involve this specific model.
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 or Device Component1
- Use of Device Problem1
Patient problems
- Insufficient Information1
- Unspecified Tissue Injury1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 28, 2021Use of Device Problem; Detachment of Device or Device Component; Use of Device Problem; Detachment of Device or Device Component
DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE ONE 6F SITESEER CATHETER TO TREAT A MILDLY TORTUOUS AND NON CALCIFIED LESION IN THE DISTAL LM ARTERY. THE DEVICE WAS REMOVED FROM THE PACKAGING, INSPECTED AND PREPPED PER IFU WITH NO ISSUES NOTED. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT WHILE ADVANCING THE DEVICE FROM THE RADIAL ROUTE TOWARDS THE LEFT CORONARY SYSTEM THE CATHETER BROKE NEAR THE AORTA. AN ATTEMPT WAS MADE TO REMOVE THE BROKEN DEVICE WITH A SNARE, HOWEVER THIS ATTEMPT LED THE CATHETER TO BREAK/ DETACH FURTHER INTO MULTIPLE PIECES. THE DEVICE WAS ALSO EXPIRED WHEN USED IN THE PATIENT. THE PATIENT IS ALIVE WITH NO INJURY.
Patient problems: Insufficient Information; Unspecified Tissue Injury
MAUDE report 12073986 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K932092. One submission often covers many models, so check the product and lot details in each record.
- Z-0523-04 · Jan 14, 2004 · TerminatedMedtronic SiteSeer 5 F Tight Radius 145 Pigtail Cardiovascular Angiographic Catheter Item Number: 5A0029
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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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