DLP® 80222Recalls & reported problems
Medtronic, Inc. · CANNULA 80222 ART METAL TIP 22FR 20PK 17 · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
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 20643169485741), received between Oct 5, 2017 and Oct 5, 2017 — classified as 1 malfunction.
The most frequently reported specific device problem is “Decoupling” (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 (K840002); 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.
Recalls naming this device
- Mar 19, 2024Open, Classified
Potential for unsealed sterile packing.
Z-1793-2024 · Root cause: Process control · FDA record ↗
Most reported problems
Device problems
- Decoupling1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 5, 2017Decoupling; Decoupling
MEDTRONIC RECEIVED INFORMATION THAT DURING DE-CANNULATION, THE METAL TIP SEPARATED FROM THE BODY OF THIS CANNULA. THERE WERE NO ADVERSE PATIENT EFFECTS AS A RESULT OF THIS PRODUCT ISSUE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6917629 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K840002. One submission often covers many models, so check the product and lot details in each record.
- Z-0986-2025 · Dec 12, 2024 · Open, ClassifiedSelect Series Angled Tip Arterial Cannula, Model Number 72422 (22 Fr)
- Z-1927-2008 · May 9, 2008 · TerminatedMedtronic Arterial Cannula Curved Beveled Tip, for Cardiopulmonary Bypass. Catalog Numbers: CB81120 and CB87022.
Other CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS devices
- DLP™ 77010Medtronic, Inc. · Catheter, cannula and tubing, vascular, cardiopulmonary bypass1 recall154 reports
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- DLP™ 77008Medtronic, Inc. · Catheter, cannula and tubing, vascular, cardiopulmonary bypass2 recalls9 reports
- NA HY11W65R1Medtronic, Inc. · Catheter, cannula and tubing, vascular, cardiopulmonary bypass2 recalls8 reports
- 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 and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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