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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 Medtronicsee related information
Date Initiated by FirmMarch 19, 2024
Date PostedMay 10, 2024
Recall Status1 Open3, Classified
Recall NumberZ-1802-2024
Recall Event ID 94274
510(K)NumberK113235 
Product Classification Gauge, pressure, coronary, cardiopulmonary bypass - Product Code DXS
ProductMedtronic Disposable Pressure Display Sets: a) DLP 114.3 cm (45 in), Model Number 61000; b) DLP 114.3 cm (45 in), Model Number 62000
Code Information a) Model Number 61000, GTIN 00643169880955, Lot Numbers: 2023030432, 2023030433; a) Model Number 61000, GTIN 20643169880959, Lot Numbers: 2023030431, 2023030432, 2023030433, 2023030734, 202305C226, 202307C176, 202307C177; b) Model Number 62000, GTIN 20613994846642, Lot Numbers: 2023030223, 2023030736, 2023031580, 202305C225
Recalling Firm/
Manufacturer		 Medtronic Perfusion Systems
7611 Northland Dr N
Brooklyn Park MN 55428-1088
For Additional Information ContactKrystin Hayward
508-261-6512
Manufacturer Reason
for Recall		Potential for unsealed sterile packing.
FDA Determined
Cause 2		Process control
ActionMedtronic 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 Commerce1624 units
DistributionWorldwide distribution.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = DXS
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