DLP recallZ-3128-2024 · Medtronic Perfusion Systems · initiated Jul 9, 2024
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Medtronic Perfusion Systems or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
During manufacturing, DLP Single Stage Venous Cannulae - straight tip (Model 66118) was incorrectly placed into a product labeled as DLP Single Stage Venous Cannulae - right angle metal tip (Model 67312).
FDA root cause category: Under Investigation by firm
What the company is doing
Medtronic issued an Urgent: Medical Device Recall notice to its consignees on 07/09/2024 via UPS. The notice explained the issue, potential risk, and requested return of the affected device. Those who further distributed the device were directed to share the notice with those to whom the affected product was distributed.
Recall details
- Recall number
- Z-3128-2024
- Status
- Open, Classified
- Initiated by the company
- Jul 9, 2024
- Posted by the FDA
- Sep 12, 2024
- Recalling firm
- Medtronic Perfusion Systems
- Quantity
- 290 units
- Product code
- DWF
- FDA submissions
- K120988
- Distribution
- Worldwide distribution - US Nationwide and the countries of Cambodia, Greece, Ireland, Italy, Saudi Arabia, Switzerland, United Kingdom, Viet Nam.
Product description
Medtronic DLP Single Stage Venous Cannulae with right angle metal tip, REF 67312
Code information (models, lots, serial numbers)
GTIN 20613994879329, Lot Numbers: 2023090954, 202312C065
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- DLP® 67312Medtronic, Inc. · CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS2 recalls1 report
Product lines
Other devices under the same FDA submission
5 devices cleared under K120988 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- DLP® 69328Medtronic, Inc. · Catheter, cannula and tubing, vascular, cardiopulmonary bypass3 reports
- DLP® 69331Medtronic, Inc. · Catheter, cannula and tubing, vascular, cardiopulmonary bypass2 reports
- DLP™ CB67312Medtronic, Inc. · Catheter, cannula and tubing, vascular, cardiopulmonary bypass1 report
- DLP™ CB67532Medtronic, Inc. · Catheter, cannula and tubing, vascular, cardiopulmonary bypass1 report
- DLP® 69316Medtronic, Inc. · Catheter, cannula and tubing, vascular, cardiopulmonary bypass1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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