Porges Coloplast ASP185Recalls & reported problems
Coloplast A/S · ELEFANT® Suction-irrigation device with connecting tube, diameter 5mm, length 450mm · Class 2
All models of Porges Coloplast (79)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03600040274125), received between May 25, 2021 and Sep 5, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Device Markings/Labelling Problem” (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.
Reports received per month
Most reported problems
Device problems
- Device Markings/Labelling Problem1
- Fluid/Blood Leak1
- Incomplete or Missing Packaging1
- Suction Failure1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 5, 2025Fluid/Blood Leak; Suction Failure; Fluid/Blood Leak; Suction Failure
ACCORDING TO THE AVAILABLE INFORMATION THE PRODUCT DIDN'T WORK PROPERLY, COULDN'T ASPIRATE AND WAS LEAKING. ACCORDING TO THE REPORT, THE NOTIFIER IDENTIFIED A BROKEN DEVICE WITHOUT DETAILS. NO HARM TO THE PATIENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22977902 ↗MalfunctionMay 25, 2021Incomplete or Missing Packaging; Device Markings/Labelling Problem; Incomplete or Missing Packaging; Device Markings/Labelling Problem
ACCORDING TO THE AVAILABLE INFORMATION, TWO DEVICES DID NOT HAVE LABELS. THE LOT COULD NOT BE DETERMINED BECAUSE IT WAS UNKNOWN WHICH PACKAGE THE DEVICES CAME FROM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11876633 ↗
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 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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