Porges Coloplast ASP165Recalls & reported problems
Coloplast A/S · ELEFANT® Suction-irrigation device with connecting tube, diameter 5mm, length 350mm · Class 2
All models of Porges Coloplast (79)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 03600040210598), received between Jan 5, 2022 and Sep 10, 2025 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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
- Detachment of Device or Device Component1
- Inability to Irrigate1
- Suction Failure1
- Tear, Rip or Hole in Device Packaging1
- Unsealed Device Packaging1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 10, 2025Inability to Irrigate; Suction Failure; Inability to Irrigate; Suction Failure
ACCORDING TO THE AVAILABLE INFORMATION THE DEVICE LEAKED DURING THE PROCEDURE. NO HARM TO THE PATIENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23017108 ↗MalfunctionAug 23, 2023Unsealed Device Packaging; Unsealed Device Packaging
ACCORDING TO AVAILABLE INFORMATION, THE PACKAGING FOR THIS DEVICE WAS NOT SEALED. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17607539 ↗MalfunctionMay 8, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE BROKE OFF IN THE PATIENT. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16890921 ↗MalfunctionJan 5, 2022Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
ACCORDING TO THE AVAILABLE INFORMATION, THE EXTERNAL PACKAGING WAS DEFECTIVE AND STERILITY OF THE DEVICE COULD NOT BE GUARANTEED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13171632 ↗
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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