Custodiol(R) 6 x 1000 mlRecalls & reported problems
Dr. Franz Köhler Chemie GmbH · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04033133610002), received between Jun 24, 2021 and Jun 25, 2021 — classified as 2 injuries.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (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.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Insufficient Device Problem Information1
Patient problems
- Insufficient Information2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJun 25, 2021Adverse Event Without Identified Device or Use Problem
THE RISK MANAGEMENT DEPARTMENT WAS MADE AWARE ON 06/17/2021 OF A SERIES OF PATIENTS THAT HAVE EXPERIENCED UNEXPECTED OUTCOMES STATUS POST TRANSPLANT SURGERY THAT OCCURRED THE WEEK OF (B)(6) 2021. THE PATIENT EXPERIENCED AN UNEXPECTED ADVERSE EVENT AFTER A KIDNEY TRANSPLANT FROM A LIVE DONOR. WHEN THE TEAM COMPARED SIMILARITIES THE COMMONALITY IS THE USE OF A PRESERVATIVE. THE PATIENT HAD TMA STATUS POST KIDNEY TRANSPLANT FROM UNKNOWN ORIGIN. THE ORGANIZATION CONTINUES TO FURTHER INVESTIGATE AND IS REPORTING TO CREATE AWARENESS IF NEEDED.
Patient problems: Insufficient Information
MAUDE report 12075025 ↗InjuryJun 24, 2021Insufficient Device Problem Information
THE PATIENT EXPERIENCED AN UNEXPECTED OUTCOMES STATUS POST KIDNEY TRANSPLANT. WHEN REVIEWING 3 CASES ALL OCCURRING DURING THE SAME WEEK ONE OF THE COMMONALITIES WAS THE PRESERVATIVE SOLUTION. WE ARE UNSURE IF THERE IS ANY CORRELATION. BASED ON PHYSICIAN ASSESSMENT THE PATIENT EXPERIENCED TMA STATUS POST TRANSPLANT OF UNKNOWN ORIGIN.
Patient problems: Insufficient Information
MAUDE report 12066309 ↗
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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