NA 6707-15 (UDI 00681490148405)Recalls & reported problems
Medtronic, Inc. · ACCESS 6707-15 KIT ADAPTER 15CM · Class 3 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00681490148405), received between Sep 14, 2018 and Sep 14, 2018 — classified as 2 injuries.
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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem2
Patient problems
- Perforation2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjurySep 14, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT DURING LASER LEAD EXTRACTION FOR A SYSTEM UPGRADE, THE PATIENT REQUIRED OPEN HEART SURGERY TO REPAIR A SMALL TEAR IN THE RIGHT VENTRICLE. A NEW SYSTEM WAS IMPLANTED A FEW DAYS LATER. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: Perforation
MAUDE report 7877321 ↗InjurySep 14, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT DURING LASER LEAD EXTRACTION FOR A SYSTEM UPGRADE, THE PATIENT REQUIRED OPEN HEART SURGERY TO REPAIR A SMALL TEAR IN THE RIGHT VENTRICLE. A NEW SYSTEM WAS IMPLANTED A FEW DAYS LATER. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: Perforation
MAUDE report 7877276 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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