DLP recallZ-1798-2024 · Medtronic Perfusion Systems · initiated Mar 19, 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
Potential for unsealed sterile packing.
FDA root cause category: Process control
What the company is doing
Medtronic issued an Urgent Medical Device Recall notice to its consignees on 03/19/2024 via letter (UPS). The notice explained the issue, potential risk, and requested the consignee identify and return the product. Consignee was directed to forward the notice to all affected parties. For questions, the consignee was directed to contact their Medtronic field representative.
Recall details
- Recall number
- Z-1798-2024
- Status
- Open, Classified
- Initiated by the company
- Mar 19, 2024
- Posted by the FDA
- May 10, 2024
- Recalling firm
- Medtronic Perfusion Systems
- Quantity
- 1760 units
- Product code
- GDJ
- Distribution
- Worldwide distribution.
Product description
Medtronic Tourniquet Sets: a) DLP 5.5 in (14.0 cm) Tourniquet Kit, Model Number 79004, b) DLP 7 in (17.8 cm) Tourniquet Kit, Model Number 79009
Code information (models, lots, serial numbers)
a) Model Number 79004, GTIN 20613994576389, Lot Numbers: 2023081324; b) Model Number 79009, GTIN 20613994576457, Lot Numbers: 2023041000, 2023041384, 202305C235
Devices named in this recall
2 devices in the FDA device registry whose identifier appears in the recall's code information.
- DLP® 79004Medtronic, Inc. · CLAMP, SURGICAL, GENERAL & PLASTIC SURGERY1 recall0 reports
- DLP® 79009Medtronic, Inc. · CLAMP, SURGICAL, GENERAL & PLASTIC SURGERY1 recall0 reports
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 94274).
- Z-1793-2024 · Open, ClassifiedMedtronic Arterial Cannulae packaged as: a) DLP Curved Metal Tip Arterial Cannula 20 Fr., Model Number 80020; b) DLP Curved Metal Tip Arterial Cannula 20 Fr., Model Number 80220…
- Z-1794-2024 · Open, ClassifiedMedtronic Clearview Blower/Mister, Model Number 22120
- Z-1795-2024 · Open, ClassifiedMedtronic DLP Coronary Ostial Cannulae, Model Number 30050
- Z-1796-2024 · Open, ClassifiedMedtronic I.M.A. Cannulae: DLP 1 mm Arteriotomy Cannula, Model Number 31001
- Z-1797-2024 · Open, ClassifiedMedtronic Left Heart Vent Catheters: a) DLP Intracardiac Sump 20 Fr, Model Number 12012, b) DLP Left Heart Vent Catheter 10 Fr., Model Number 12008, c) DLP Left Heart Vent Cath…
- Z-1799-2024 · Open, ClassifiedMedtronic Vessel Cannulae: a) DLP 2 mm Vessel Cannula Blunt Tip, Model Number 30004; b) DLP 3 mm Vessel Cannula Blunt Tip, Model Number 30003
- Z-1800-2024 · Open, ClassifiedMedtronic Aortic Root Cannulae and Cardioplegia Needles: a) DLP 9 Ga (11 Fr) Aortic Root Cannula, Model Number 24009; b) DLP 16 Ga (5 Fr) Cardioplegia Needle Neonatal 0.64 cm…
- Z-1801-2024 · Open, ClassifiedMedtronic Cardioplegia Adapters: a) DLP 1.8 m (6 ft) Pressure Monitoring Extension Line Adapter, Model Number 25009, b) DLP 1.8 m (6 ft) Pressure Monitoring Extension Line Adapt…
- Z-1802-2024 · Open, ClassifiedMedtronic Disposable Pressure Display Sets: a) DLP 114.3 cm (45 in), Model Number 61000; b) DLP 114.3 cm (45 in), Model Number 62000
- Z-1803-2024 · Open, ClassifiedMedtronic Intracoronary Shunts: a) ClearView 1.00 mm Intracoronary Shunt, Model Numbers: 31100; b) ClearView 1.25 mm Intracoronary Shunt, Model Numbers: 31125; c) ClearView 2…
- Z-1804-2024 · Open, ClassifiedMedtronic Suction Tubes: a) DLP Suction Tube 6-Fr. Shaft with Frazier Tip, Model Number: 10050, b) DLP Suction Tube 6-Fr. Shaft with 10-Fr. Soft Tip, Model Number: 10052, c) D…
- Z-1805-2024 · Open, ClassifiedMedtronic Venous Cannulae: a) DLP 20 Fr. Malleable Single Stage Venous Cannula, Model Number 68120, b) DLP 24 Fr. Malleable Single Stage Venous Cannula, Model Number 68124, c) …
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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