DOSI-FUSERRecalls & reported problems across all models
Leventon Sau · 3 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 1
We found 3 models of DOSI-FUSER by Leventon Sau in the FDA's device registry (GUDID). Together they are named in 1 adverse event report in the FDA's MAUDE database, received between May 30, 2018 and May 30, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Burst Container or Vessel” (1 report).
1 FDA recall record name at least one of these models by its device identifier.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
DOSI-FUSER recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- May 23, 2019Class IITerminated
The product lacks 510(k) clearance, and therefore is misbranded and must be removed from the U.S. market.
Z-2360-2019 · Root cause: No Marketing Application · names 2 of these models · Recall details · FDA record ↗
Most reported DOSI-FUSER problems
Device problems
- Burst Container or Vessel1
Patient problems
- No Known Impact Or Consequence To Patient1
DOSI-FUSER models
3 models, most reported first. Each model has its own page with its reports, recalls and device details.
- DOSI-FUSER L25915-500D1-USAPump, Infusion, Elastomeric1 recall0 reports
- DOSI-FUSER L25915-600D1-USAPump, Infusion, Elastomeric1 recall0 reports
- DOSI-FUSER L25915-250D5-FDAPump, Infusion, Elastomeric1 report
Recent DOSI-FUSER adverse event reports
The 1 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionMay 30, 2018Burst Container or Vessel; Burst Container or Vessel
LEAKAGE OF CHEMOTHERAPY SOLUTION (2-5 ML) FROM ELASTOMERIC BALLOON INTO PUMP CAPSULE. SOLUTION WAS CONTAINED WITHIN PUMP AND DID NOT LEAK OUTSIDE OF INFUSION DEVICE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7552689 ↗
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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