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U.S. Department of Health and Human Services

Class 2 Device Recall Medtronic

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  Class 2 Device Recall Medtronic see related information
Date Initiated by Firm March 19, 2024
Date Posted May 10, 2024
Recall Status1 Open3, Classified
Recall Number Z-1797-2024
Recall Event ID 94274
510(K)Number K850385  
Product Classification Catheter, cannula and tubing, vascular, cardiopulmonary bypass - Product Code DWF
Product 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,
Code Information a) Model Number 12012, GTIN 20613994619246, Lot Numbers: 2023050080, 202306C144; b) Model Number 12008, GTIN 00643169880665, Lot Numbers: 2023040819; b) Model Number 12008, GTIN 00673978176307, Lot Numbers: 2023040819, 2023040820; b) Model Number 12008, GTIN 20643169880669, Lot Numbers: 2023040819, 2023040820, 202307C103; c) Model Number 12001, GTIN 00643169878686, Lot Numbers: 2023040810; c) Model Number 12001, GTIN 20643169878680, Lot Numbers: 2023040810, 2023040811, 202306C141; d) Model Number 12113, GTIN 20643169881338, Lot Numbers: 2023090675; e) Model Number 12016, GTIN 20613994540434, Lot Numbers: 2023050083, 202305C093; f) Model Number 12002, GTIN 20613994540465, Lot Numbers: 2023041178, 202305C079; g) Model Number 12220, GTIN 00613994540355, Lot Numbers: 2023041202, 2023050095; g) Model Number 12220, GTIN 20613994540359, Lot Numbers: 2023041202, 2023050095, 202305C096, 202306C159; h) Model Number 12010, GTIN 00673978176321, Lot Numbers: 2023041180, 2023041182, 2023041183, 2023041188, 2023041189, 2023050075; h) Model Number 12010, GTIN 20613994619215, Lot Numbers: 2023041180, 2023041181, 2023041182, 2023041183, 2023041184, 2023041188, 2023041189, 2023050075, 202305C086, 202305C087
Recalling Firm/
Manufacturer		 Medtronic Perfusion Systems
7611 Northland Dr N
Brooklyn Park MN 55428-1088
For Additional Information Contact Krystin Hayward
508-261-6512
Manufacturer Reason
for Recall		 Potential for unsealed sterile packing.
FDA Determined
Cause 2		 Process control
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.
Quantity in Commerce 13954 units
Distribution Worldwide distribution.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = DWF and Original Applicant = DLP, INC.
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