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Open, Classified

Medtronic 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 Adapter, Model Number 25010, c) DLP 30.5 cm (12 in) Multiple Perfusion Set, Model Number 14003, d) DLP 38.1 cm (15 in) Multiple Perfusion Set, Model Number 14000, e) DLP 50.8 cm (20 in) Extension Line Adapter, Model Number 11001G, f) DLP Perfusion/Venting Adapter, Model Number 13002, g) DLP Y Adapter Coronary Perfusion, Model Number 10710

FDA Recall Z-1801-2024 · Posted 2024-05-10

Recalling FirmMedtronic Perfusion Systems
Recall StatusOpen, Classified
Product CodeDWF
Date Initiated2024-03-19
Product Quantity6290 units

Reason for Recall

Potential for unsealed sterile packing.

Firm Action

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.

Root Cause

Process control

Distribution Pattern

Worldwide distribution.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K182586DLP Aortic Root Cannula, DLP Aortic Root Cannula with Vent Line, DLP Pressure Monitoring Extension Line Adapter, DLP Cardioplegia Adapter with Pressure PortMedtronic, Inc. · 2018-10-19

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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