Elefant ASP165Recalls & reported problems
Coloplast A/S · Class 2
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 03600040970676), received between Jun 23, 2025 and Jan 13, 2026 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Free or Unrestricted Flow” (2 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
- Free or Unrestricted Flow2
- Inability to Irrigate2
- Suction Failure2
- Inaccurate Delivery1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- Insufficient Information1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 13, 2026Free or Unrestricted Flow
According to the available information while suction and water delivery were possible during use of the product, water delivery continued even when no button operations were performed on the device.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24056556 ↗MalfunctionDec 5, 2025Inaccurate Delivery; Inaccurate Delivery
ACCORDING TO THE AVAILABLE INFORMATION SUCTION AND WATER DELIVERY ARE POSSIBLE, BUT WATER DELIVERY CONTINUES EVEN WHEN THE BUTTON IS NOT PRESSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23727885 ↗MalfunctionSep 29, 2025Inability to Irrigate; Suction Failure; Inability to Irrigate; Suction Failure
ACCORDING TO THE AVAILABLE INFORMATION THE DEVICE DOES NOT WORK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23167909 ↗MalfunctionSep 19, 2025Inability to Irrigate; Suction Failure; Inability to Irrigate; Suction Failure
ACCORDING TO THE AVAILABLE INFORMATION THE DEVICE DOES NOT SUCK OR FLUSH.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23097625 ↗MalfunctionJun 23, 2025Free or Unrestricted Flow; Free or Unrestricted Flow
ACCORDING TO THE AVAILABLE INFORMATION WHILE USING THE DEVICE, THE WATER SUPPLY DID NOT STOP.
Patient problems: Insufficient Information
MAUDE report 22308156 ↗
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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.