DLP® 10007Recalls & reported problems
Medtronic, Inc. · ADAPTER 10007 PERFUSION 1/4IN 40PK 17L · Class 2
- 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 20613994756705), received between Dec 19, 2018 and Dec 19, 2018 — classified as 1 injury.
The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Break1
Patient problems
- Ischemia1
- Vascular System (Circulation), Impaired1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryDec 19, 2018Break; Break
MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A DLP PERFUSION ADAPTER WHEN THE PATIENT (ON FULL VA-ECMO SUPPORT) WAS BEEN BROUGHT FROM INTENSIVE CARE TO THE OPERATING ROOM THE CONNECTOR BROKE. THE BREAK PARTIALLY STOPPED BLOOD CIRCULATION TO THE PATIENT FOR APPROXIMATELY 2 MINUTES. THE ADAPTER HAD BEEN IN PLACE FOR 4 DAYS. THERE WAS NO LEAK AS AIR WAS ASPIRATED THROUGH THE BROKEN CONNECTOR. IT IS UNKNOWN IF THE DEVICE WAS REPLACED.
Patient problems: Ischemia; Vascular System (Circulation), Impaired
MAUDE report 8178156 ↗
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- PhD™ 00884450746714Merit Medical Systems, Inc. · Adaptor, stopcock, manifold, fitting, cardiopulmonary bypass1 recall1 report
- NAMIC 64038301Medline Industries, Inc. · Adaptor, stopcock, manifold, fitting, cardiopulmonary bypass1 recall1 report
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.