DLP® 94965Recalls & reported problems
Medtronic, Inc. · CANNULA 94965 RCSP 15F SIL MAN 10PK 17L · 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
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
1 FDA recall record name this device's identifier, 1 still open.
7 other recalls cover devices cleared under the same FDA submission (K953945); 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
- Apr 21, 2026Open, Classified
Certain lots of product have the potential for a sterile barrier breach.
Z-2222-2026 · Root cause: Packaging process control · FDA record ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K953945. One submission often covers many models, so check the product and lot details in each record.
- Z-2221-2026 · Apr 21, 2026 · Open, ClassifiedMedtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94915; Cardiopulmonary bypass vascular catheter
- Z-2219-2026 · Apr 21, 2026 · Open, ClassifiedMedtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94913; Cardiopulmonary bypass vascular catheter
- Z-2214-2026 · Apr 21, 2026 · Open, ClassifiedMedtronic GUNDRY Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94113T; Cardiopulmonary bypass vascular catheter
- Z-2218-2026 · Apr 21, 2026 · Open, ClassifiedMedtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94725; Cardiopulmonary bypass vascular catheter
- Z-2216-2026 · Apr 21, 2026 · Open, ClassifiedMedtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94215T; Cardiopulmonary bypass vascular catheter
- Z-2220-2026 · Apr 21, 2026 · Open, ClassifiedMedtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94913L; Cardiopulmonary bypass vascular catheter
- Z-2217-2026 · Apr 21, 2026 · Open, ClassifiedMedtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94665; Cardiopulmonary bypass vascular catheter
Other CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS devices
- DLP™ 77010Medtronic, Inc. · Catheter, cannula and tubing, vascular, cardiopulmonary bypass1 recall154 reports
- EOPA™ 77422Medtronic, Inc. · Catheter, cannula and tubing, vascular, cardiopulmonary bypass2 recalls19 reports
- 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
- 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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