DBS™ Reclaim® 3391S-40Recalls & reported problems
Medtronic, Inc. · LEAD 3391S-40 NO OR CBL MRI COND EMN ALP · Class f · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169864283), received between Sep 9, 2021 and Sep 9, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Damaged Prior to Receipt by User” (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
- Device Damaged Prior to Receipt by User1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 9, 2021Device Damaged Prior to Receipt by User; Device Damaged Prior to Receipt by User
IT WAS REPORTED THAT AN OFF THE SHELF DEEP BRAIN STIMULATION (DBS) LEAD BEING USED FOR OUT STUDY WAS RECEIVED WITH A CORNER TORN OFF THE BOX. ADDITIONAL INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP) REPORTING THAT THE LEAD WAS SENT TO BE USED IN A CLINICAL STUDY (B)(6). THE LEAD WAS NOT USED AS THIS WAS DISCOVERED AT THE TIME THE SUPPLY SHIPMENT WAS RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12448954 ↗
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- DBS™ 3391S-40Medtronic, Inc. · Deep brain stimulator for obsessive compulsive disorder (OCD)2 reports
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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