ElefantRecalls & reported problems across all models
Coloplast A/S · 4 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 274
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 0
We found 4 models of Elefant by Coloplast A/S in the FDA's device registry (GUDID). Together they are named in 274 adverse event reports in the FDA's MAUDE database, received between Jun 23, 2025 and Apr 2, 2026 — classified as 274 malfunctions.
The most frequently reported specific device problem is “Suction Failure” (266 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. 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
Reports received per month, all models
Most reported Elefant problems
Device problems
- Suction Failure266
- Inability to Irrigate249
- Suction Problem3
- Complete Blockage2
- Device Misassembled During Manufacturing /Shipping2
- Free or Unrestricted Flow2
- Inaccurate Delivery1
- Material Separation1
Patient problems
- No Clinical Signs, Symptoms or Conditions272
- Foreign Body In Patient1
- Insufficient Information1
Elefant models
4 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Elefant ASP185LAVAGE, JET260 reports
- Elefant ASP145LAVAGE, JET6 reports
- Elefant ASP165LAVAGE, JET5 reports
- Elefant ASP180LAVAGE, JET3 reports
Recent Elefant adverse event reports
The 15 most recent reports across all models, 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 ↗MalfunctionMar 5, 2026Suction Failure
ACCORDING TO THE AVAILABLE INFORMATION THE MEDICAL TEAMS NOTICED THAT A SUCTION DEVICE WAS NOT WORKING. THEY CHECKED THAT THEIR SUCTION SYSTEM WAS WORKING PROPERLY BY DISCONNECTING IT, WHICH WAS INDEED THE CASE. AFTER CHECKING SEVERAL UNITS FROM THIS LOT, THEY FOUND THAT NONE OF THEM WERE WORKING. HOWEVER, UNITS FROM A DIFFERENT LOT WERE WORKING NORMALLY. THREE DEFECTIVE SUCTION DEVICES CURRENTLY ARE IN QUARANTINE. THEY ARE CURRENTLY USING SUCTION DEVICES FROM DIFFERENT LOTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24518871 ↗MalfunctionMar 5, 2026Suction Failure
ACCORDING TO THE AVAILABLE INFORMATION THE MEDICAL TEAMS NOTICED THAT A SUCTION DEVICE WAS NOT WORKING. THEY CHECKED THAT THEIR SUCTION SYSTEM WAS WORKING PROPERLY BY DISCONNECTING IT, WHICH WAS INDEED THE CASE. AFTER CHECKING SEVERAL UNITS FROM THIS LOT, THEY FOUND THAT NONE OF THEM WERE WORKING. HOWEVER, UNITS FROM A DIFFERENT LOT WERE WORKING NORMALLY. THREE DEFECTIVE SUCTION DEVICES CURRENTLY ARE IN QUARANTINE. THEY ARE CURRENTLY USING SUCTION DEVICES FROM DIFFERENT LOTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24518869 ↗MalfunctionMar 5, 2026Suction Failure
ACCORDING TO THE AVAILABLE INFORMATION THE MEDICAL TEAMS NOTICED THAT A SUCTION DEVICE WAS NOT WORKING. THEY CHECKED THAT THEIR SUCTION SYSTEM WAS WORKING PROPERLY BY DISCONNECTING IT, WHICH WAS INDEED THE CASE. AFTER CHECKING SEVERAL UNITS FROM THIS LOT, THEY FOUND THAT NONE OF THEM WERE WORKING. HOWEVER, UNITS FROM A DIFFERENT LOT WERE WORKING NORMALLY. THREE DEFECTIVE SUCTION DEVICES CURRENTLY ARE IN QUARANTINE. THEY ARE CURRENTLY USING SUCTION DEVICES FROM DIFFERENT LOTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24518868 ↗MalfunctionFeb 19, 2026Complete Blockage; Suction Failure
ACCORDING TO THE AVAILABLE INFORMATION SUCTION STOPPED ABRUPTLY, IMPOSSIBLE TO RELIEVE BLOCKAGE. IMPOSSIBLE TO SUCTION HEAVY BLEEDING DURING ROBOTIC LAPAROSCOPY. IMMEDIATE AND QUICK REPLACEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24389127 ↗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 30, 2025Missing Information; Missing Information
ACCORDING TO THE AVAILABLE INFORMATION PRODUCT WAS DELIVERED WITHOUT PRODUCT STICKERS/ IDENTIFICATION LABELS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23927877 ↗MalfunctionDec 22, 2025Suction Failure; Suction Failure
ACCORDING TO THE AVAILABLE INFORMATION THE DEVICE FAILED DURING ACTIVATION OF THE SUCTION. THE DEVICE WAS NOT USED AND WAS REPLACED WITH ANOTHER UNIT FROM THE SAME LOT, WHICH DID NOT SHOW ANY DEVIATION. NO PATIENT HARM HAS BEEN REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23863590 ↗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 ↗MalfunctionOct 20, 2025Material Separation; Material Separation
ACCORDING TO THE AVAILABLE INFORMATION THE CANNULA OF THE DEVICE BROKE DURING PROCEDURE. AS REPORTED BY THE PHYSICIAN THE CANNULA BROKE INSIDE THE ABDOMINAL CAVITY OF THE PATIENT. THE DOCTOR KEPT THE BROKEN CANNULA THROUGHOUT THE PROCEDURE AND WAS ABLE TO COMPLETE IT WITHOUT NEEDING A REPLACEMENT OF THE DEVICE, BECAUSE THE DEVICE REMAINED FUNCTIONAL AND WITHOUT RISK TO THE PATIENT, EVEN WITH THE BROKEN CANNULA. NO HARM TO THE PATIENT WAS REPORTED.
Patient problems: Foreign Body In Patient
MAUDE report 23335888 ↗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 23, 2025Inability to Irrigate; Suction Failure; Inability to Irrigate; Suction Failure
ACCORDING TO THE AVAILABLE INFORMATION THE TUBING FROM THE SAME BATCH DOES NOT SUCK. PROBLEM OCCURRED 3 TIMES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23124113 ↗MalfunctionSep 23, 2025Inability to Irrigate; Suction Failure; Inability to Irrigate; Suction Failure
ACCORDING TO THE AVAILABLE INFORMATION THE TUBING FROM THE SAME BATCH DOES NOT SUCK. PROBLEM OCCURRED 3 TIMES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23124107 ↗MalfunctionSep 23, 2025Inability to Irrigate; Suction Failure; Inability to Irrigate; Suction Failure
ACCORDING TO THE AVAILABLE INFORMATION THE TUBING FROM THE SAME BATCH DOES NOT SUCK. PROBLEM OCCURRED 3 TIMES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23124104 ↗MalfunctionSep 23, 2025Inability to Irrigate; Suction Failure; Inability to Irrigate; Suction Failure
ACCORDING TO THE AVAILABLE INFORMATION THERE WAS NO ASPIRATION ON THREE DEVICES FROM THE SAME LOT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23122183 ↗
Other Coloplast A/S products
All Coloplast A/S devices →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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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