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Open, Classified

Medtronic 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 Catheter 13 Fr., Model Number 12001, d) DLP Left Heart Vent Catheter 13 Fr., Model Number 12113, e) DLP Left Heart Vent Catheter 16 Fr., Model Number 12016, f) DLP Left Heart Vent Catheter 20 Fr. Model Number 12002, g) DLP Left Heart Vent Catheter 20 Fr. Model Number 12220, h) DLP Pericardial Sump 38.1 cm (15 in), Model Number 12010,

FDA Recall Z-1797-2024 · Posted 2024-05-10

Recalling FirmMedtronic Perfusion Systems
Recall StatusOpen, Classified
Product CodeDWF
Date Initiated2024-03-19
Product Quantity13954 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.

K850385INTRACARDIAC SUMP 12010Dlp, Inc. · 1985-04-29

Official Source

View FDA Recall →

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

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