DELTAPLUSH DPL100306-20Recalls & reported problems
Medos International Sàrl · DELTAPLUSH microcoil DELTAPLUSH 10 Stretch Resistant Coil 3mm x 6cm 190cm Contents: 1 Detachable Coil System · Class 2 · Implant
Data updated Oct 16, 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 00878528008125), received between Oct 3, 2016 and Oct 3, 2016 — classified as 1 malfunction.
The most frequently reported specific device problem is “Stretched” (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 16, 2026.
Most reported problems
Device problems
- Stretched1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 3, 2016Stretched; Stretched
AS REPORTED BY A HEALTH CARE PROFESSIONAL, DURING COILING OF AN ANEURYSM IN A (B)(6) FEMALE, PHYSICIAN FRAMED ANEURYSM WITH MICRUSPHERE 5X14 (LOT UNKNOWN). DURING POSITIONING OF SECOND COIL DELTAPLUSH 3X6 (DPL10030620/P10134) THROUGH A COMPETITOR'S MICROCATHETER, PHYSICIAN THOUGHT THE COIL PREMATURELY DETACHED. UPON FURTHER ANALYSIS, THE COIL WAS DETERMINED TO HAVE STRETCHED IN THE MICROCATHETER. THE PHYSICIAN REMOVED THE MICROCATHETER WITH THE COIL FULLY INSIDE. NO SIGNIFICANT CASE DELAY RESULTED. NO PATIENT INJURY RESULTED. MICROCATHETER AND COIL ARE AVAILABLE FOR ANALYSIS. LATER IN THE SAME PROCEDURE THE PHYSICIAN ATTEMPTED TO ADVANCE A DELTAPLUS 2X6 COIL (DPL10020620/S10146), WHICH WAS DETERMINED TO BE TOO BIG. THE PHYSICIAN ATTEMPTED TO RESHEATH THE COIL BUT THE SHEATH TORE DURING THE PROCESS. NO PATIENT INJURY RESULTED. COIL AVAILABLE FOR ANALYSIS. PROCEDURE WAS COILING OF AN UNRUPTURED LEFT SUPRACLINOID ANEURYSM OF DIMENSION 5.7 X 3.6 MM. THE PATIENT'S VESSELS WERE REPORTED TO BE OF HIGH TORTUOSITY. IN TOTAL, PHYSICIAN PLACED 7 COILS (1 MICRUSPHERE, 4 DELTAPLUSH AND 2 TARGET NANO). PATIENT IS REPORTED TO BE IN A STABLE CONDITION AND RECOVERING.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 5994641 ↗
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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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