DLP PERICARDIAL SUMP
Received May 18, 2026 · Event occurred May 15, 2026
Report 3003955307-2026-00085 · MDR key 25201467
Device
Generic name
Sucker, Cardiotomy Return, Cardiopulmonary Byp
Manufacturer
Medtronic Grand RapidsModel number
12010Catalog number
12010
Lot number
0232363317
Product problems
- Mechanical Problem
- Material Separation
Patient
NA · Unknown
- Unspecified Tissue Injury
Narrative
Description of Event or Problem
MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A DLP PERICARDIAL SUMP, IT WAS REPORTED THAT THE WIRE MESH OF THE CANNULA HAS COME LOOSE, CAUSING TRAUMA TO THE HEART TISSUE. PATIENT RECOVERY IS UNKNOWN. THE USE OF THE DEVICE WAS UNSPECIFIED.
Additional Manufacturer Narrative
MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.