DLP® 12002Recalls & reported problems
Medtronic, Inc. · SUCTION 12002 LV VENT 20FR SIL 20PK 17L · Class 2
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20613994540465), received between Jan 16, 2025 and Jan 16, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Mechanical Problem” (1 report).
1 FDA recall record name this device's identifier, 1 still open.
2 other recalls cover devices cleared under the same FDA submission (K834352); they may or may not involve this specific model.
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.
Reports received per month
Recalls naming this device
- Mar 19, 2024Open, Classified
Potential for unsealed sterile packing.
Z-1797-2024 · Root cause: Process control · FDA record ↗
Most reported problems
Device problems
- 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.
MalfunctionJan 16, 2025Mechanical Problem; Mechanical Problem
IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING THE INSERTION OF A DLP LEFT HEART VENT CATHETER, THE CUSTOMER EXPERIENCED DIFFICULTY WITH THE INSERTION PROCESS. THE CUSTOMER NOTED THAT THE WIRE STYLET IN THE LEFT VENTRICLE (LV) LEAD VENT WAS NOT AS STIFF AS USUAL AND DESCRIBED THE VENT AS BEING MORE FLOPPY, WHICH MADE IT CHALLENGING TO INSERT. THE CUSTOMER INQUIRED WHETHER THE DEVICE MATERIAL HAD BEEN CHANGED, AS THIS WAS THE ONLY TYPE OF VENT TYPICALLY USED. IT WAS NOTED THAT THE CUSTOMER WAS HIGHLY EXPERIENCED AND THE ISSUE WAS NOT ATTRIBUTED TO PATIENT ANATOMY. THE DEVICE WAS REPLACED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21167088 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K834352. One submission often covers many models, so check the product and lot details in each record.
- Z-2504-2021 · Aug 24, 2021 · Open, ClassifiedDLP Left Heart Vent Catheters, 16 FR. Sterile, Rx Only
- Z-2505-2021 · Aug 24, 2021 · Open, ClassifiedDLP Left Heart Vent Catheters, 18 FR. Sterile, Rx Only
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.