DLP® 50010Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 20613994654056), received between May 20, 2019 and May 30, 2019 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (2 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, 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

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMay 30, 2019Break; Break

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE THE TIP OF THIS DLP LEFT ATRIAL PRESSURE MONITORING CATHETER PLACEMENT SET BROKE OFF INSIDE THE PATIENT AND WAS SUBSEQUENTLY REMOVED. SEE THE ATTACHED IMAGE. THE CUSTOMER WAS UNABLE TO PROVIDE ADDITIONAL PATIENT, PRODUCT, OR PROCEDURAL INFORMATION RELATED TO THIS INCIDENT. IT IS UNKNOWN HOW LONG THE CATHETER PLACEMENT SET WAS IN THE PATIENT, HOW THE CATHETER PLACEMENT SET WAS BEING HANDLED AT THE TIME OF THE REPORTED BREAK, OR WHAT PROCEDURE WAS REQUIRED TO REMOVE THE CATHETER PLACEMENT SET FROM THE PATIENT. NO SERIOUS INJURY, ADDITIONAL MEDICAL INTERVENTION, OR FOLLOW-UP CARE RELATED TO THIS INCIDENT WAS REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 8653338 ↗
• InjuryMay 30, 2019Break; Break

  MEDTRONIC RECEIVED INFORMATION THAT WHEN THE PATIENT WAS BEING MONITORED IN THE FACILITY'S CARDIAC INTENSIVE CARE UNIT POST-OPERATIVELY AND WHEN A STAFF MEMBER REPOSITIONED THE HUB OF THE DLP LEFT ATRIAL PRESSURE MONITORING CATHETER PLACEMENT SET BY PEELING BACK THE SECUREMENT TAPE, THE LINE FELL APART. WHEN THIS OCCURRED, THE CATHETER PLACEMENT SET WAS REPORTEDLY CLAMPED ON THE EXPOSED END, CLEANED WITH CHOLRAPREP AND COVERED WITH A TAGADERM. THE CUSTOMER STATED THAT THE CATHETER PLACEMENT SET LINE WAS LEFT IN THE PATIENT AND REMOVED THE NEXT DAY BY THE CARDIOVASCULAR OPERATING ROOM TEAM. IT IS UNKNOWN HOW LONG THE DEVICE HAD BEEN IN USE WHEN THE BREAK OCCURRED. IT IS UNKNOWN HOW THE DEVICE WAS REMOVED FROM THE PATIENT. THERE WAS NO SERIOUS INJURY NOTED AND NO FOLLOW-UP CARE NOTED. NO ADDITIONAL MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER STATED THAT THE PATIENT IS STABLE, NO ISSUES RELATED TO THIS INCIDENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 8653250 ↗
• MalfunctionMay 20, 2019Crack; Crack

  MEDTRONIC RECEIVED INFORMATION VIA USER FACILITY MEDWATCH, THAT DURING USE WHEN THE NURSE WAS SCRUBBING THE HUB BETWEEN THE RADIAL ARTERY LUMEN AND 50010 LEFT ATRIAL PRESSURE MONITORING SET TUBING TO PREPARE FOR A LINE CHANGE, THEY NOTED BLOOD TO BE BACKING UP INTO THE LINE. WHILE ATTEMPTING TO DRAW BACK THE BLOOD, AIR WAS OBSERVED IN THE SYRINGE AND THE TUBING WAS THEN NOTED TO BE CRACKED. THE LINE WAS CLAMPED AND THE PRODUCT REPLACED. THE ONLY PATIENT IMPACT REPORTED WAS NOT BEING ABLE TO PERFORM APPROPRIATE MONITORING AFTER SURGERY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8623399 ↗