DLP® 50011Recalls & reported problems
Medtronic, Inc. · PCP SET 50011 5FR - 14GA 10PK 17L · Class 2
All models of DLP (151)
Data updated Oct 16, 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 20613994654063), received between Jan 20, 2022 and Jan 20, 2022 — 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Break1
- Material Puncture/Hole1
- Mechanical Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJan 20, 2022Break; Mechanical Problem; Material Puncture/Hole; Break; Mechanical Problem; Material Puncture/Hole
MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A 50011 DLP LEFT ATRIAL PRESSURE MONITORING CATHETER PLACEMENT SET, THE CUSTOMER OBSERVED THAT WHEN THE CATHETER WAS INSERTED AND THEY TRIED TO OPEN AND PEEL AWAY THE NEEDLE THE WINGS BROKE AND IT WAS VERY DIFFICULT TO REMOVE. THE CUSTOMER THEN USED BONE WAX IN ORDER TO AVOID ANY SERIOUS PROBLEMS FOR THE PATIENT. THE DEVICE WAS DISCARDED AND WILL NOT BE RETURNED. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13307191 ↗
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- EOPA™ 77622Medtronic, Inc. · Catheter, cannula and tubing, vascular, cardiopulmonary bypass2 recalls4 reports
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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