Palapress Vario 64707889Recalls & reported problems
Kulzer GmbH · Palapress Vario, pink, 500g · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI J014647078890), received between Oct 13, 2023 and Oct 13, 2023 — classified as 1 injury.
The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (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
- Improper or Incorrect Procedure or Method1
Patient problems
- Dyspnea1
- Hypersensitivity/Allergic reaction1
- Swelling/ Edema1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryOct 13, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method
A PATIENT CLAIMED TO HAVE EXPERIENCED SWELLING AND SHORTNESS OF BREATH AFTER HER PROSTHESIS WAS RELINED WITH PALAPRESS VARIO. THE PATIENT IS REPORTED TO HAVE BEEN TESTED ALLERGIC TO BPO. IT WAS REPORTED DURING THE FIRST CONTACT THAT THE PATIENT IS CURRENTLY DOING WELL.
Patient problems: Dyspnea; Hypersensitivity/Allergic reaction; Swelling/ Edema
MAUDE report 17928842 ↗
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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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