DLP® 68120Recalls & reported problems
Medtronic, Inc. · CANNULA 68120 SS VEN MALL 20FR 10PK 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 20613994879435), received between Nov 19, 2025 and Nov 19, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Crack” (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 (K022272); 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-1805-2024 · Root cause: Process control · FDA record ↗
Most reported problems
Device problems
- Crack1
- Obstruction of Flow1
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.
MalfunctionNov 19, 2025Crack; Obstruction of Flow; Crack; Obstruction of Flow
IT WAS REPORTED THAT A PATIENT ON ECMO (EXTRA CORPOREAL MEMBRANE OXYGENATION) FOR 11 DAYS WITH CENTRAL CANNULATION EXPERIENCED CLOTTING WITH THE DLP MALLEABLE SINGLE STAGE VENOUS CANNULA, AS THE CANNULA WAS NOT DRAINING AND WAS OBSERVED TO BE BROKEN IN MULTIPLE PLACES WITH A CLOT STUCK WHERE IT WAS BROKEN. THE ISSUE WORSENED OVER TIME. THE CANNULA 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 23592011 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K022272. One submission often covers many models, so check the product and lot details in each record.
- Z-0810-2012 · Dec 14, 2011 · TerminatedMedtronic, DLP, DLP Malleable Single Stage Venous Cannulae. Rx Only, Sterilized Using Ethylene Oxide, Nonpyrogenic. Model #'s 68112, 68114, 68116, 68118, 68120, 68122, 68124, 68
- Z-0812-2012 · Dec 14, 2011 · TerminatedMedtronic, Single Stage Venous Cannula, Carmeda Bio-Active Surface Venous Cannula, Sterilized Using Ethylene Oxide, Rx Only, Nonpyrogenic. Model # 's CB66112, CB66114, CB66116,
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- DLP® 12113Medtronic, Inc. · Catheter, cannula and tubing, vascular, cardiopulmonary bypass2 recalls6 reports
- DLP® Aortic Root Cannula with Flow-Guard™ 11012Medtronic, Inc. · CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS2 recalls5 reports
- EOPA™ 77622Medtronic, Inc. · Catheter, cannula and tubing, vascular, cardiopulmonary bypass2 recalls4 reports
- NA HY2V10R33Medtronic, Inc. · Catheter, cannula and tubing, vascular, cardiopulmonary bypass2 recalls3 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.