Elefant ASP145Recalls & reported problems
Coloplast A/S · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 03600040970614), received between Sep 11, 2025 and Apr 2, 2026 — classified as 6 malfunctions.
The most frequently reported specific device problem is “Suction Failure” (5 reports).
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.
Reports received per month
Most reported problems
Device problems
- Suction Failure5
- Complete Blockage1
Patient problems
- No Clinical Signs, Symptoms or Conditions6
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 2, 2026Complete Blockage
ACCORDING TO THE AVAILABLE INFORMATION, THE DEVICE CLOGGED DURING USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24768977 ↗MalfunctionSep 11, 2025Suction Failure; Suction Failure
ACCORDING TO THE AVAILABLE INFORMATION THE CANNULAS DON'T ASPIRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23030457 ↗MalfunctionSep 11, 2025Suction Failure; Suction Failure
ACCORDING TO THE AVAILABLE INFORMATION THE CANNULAS DON'T ASPIRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23030434 ↗MalfunctionSep 11, 2025Suction Failure; Suction Failure
ACCORDING TO THE AVAILABLE INFORMATION THE CANNULAS DON'T ASPIRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23030433 ↗MalfunctionSep 11, 2025Suction Failure; Suction Failure
ACCORDING TO THE AVAILABLE INFORMATION THE CANNULAS DON'T ASPIRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23030413 ↗MalfunctionSep 11, 2025Suction Failure; Suction Failure
ACCORDING TO THE AVAILABLE INFORMATION THE CANNULAS DON'T ASPIRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23030405 ↗
Other LAVAGE, JET devices
- Elefant ASP185Coloplast A/S · LAVAGE, JET260 reports
- PULSAVAC® 00-5150-475-01Zimmer Orthopaedic Surgical Products, Inc. · LAVAGE, JET255 reports
- PULSAVAC® 00-5150-482-00Zimmer Orthopaedic Surgical Products, Inc. · LAVAGE, JET197 reports
- PULSAVAC® 00-5150-475-00Zimmer Orthopaedic Surgical Products, Inc. · LAVAGE, JET164 reports
- Versajet 66800039Smith & Nephew Medical Limited · Lavage, Jet160 reports
- PULSAVAC® 00-5150-482-01Zimmer Orthopaedic Surgical Products, Inc. · LAVAGE, JET154 reports
- Surgiphor 910110Carefusion 2200, Inc · LAVAGE, JET140 reports
- Axius Blower/Mister CB-1000Maquet Cardiovascular LLC · Lavage, Jet1 recall43 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 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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