This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program. The FDA has become aware of a potentially high-risk device issue. The FDA will keep the public informed and update this web page as significant new information becomes available.

Affected Product

The FDA is aware that Medtronic has issued a letter to affected customers recommending certain Left Heart Vent Catheters be removed from where they are used or sold:

Device Name	UDI-DI	Model Number
DLP Left Heart Vent Catheter Malleable body and vented connector	20643169880676	12110
DLP Left Heart Vent Catheter Malleable body and vented connector	20643169881338	12113
DLP Left Heart Vent Catheter Malleable body and vented connector	20643169880935	12115

Model Number	UDI	Lot
12110	20643169880676	2023120708
12110	20643169880676	2023121042
12110	20643169880676	2024020138
12110	20643169880676	2024020473
12110	20643169880676	2024030361
12110	20643169880676	2024050075
12110	20643169880676	2024050763
12110	20643169880676	2024060285
12110	20643169880676	2024080225
12110	20643169880676	2024090229
12110	20643169880676	2024100622
12110	20643169880676	202403C145
12110	20643169880676	202406C066
12110	20643169880676	2023120709
12110	20643169880676	2024011203
12110	20643169880676	2024020139
12110	20643169880676	2024020474
12110	20643169880676	2024030833
12110	20643169880676	2024050076
12110	20643169880676	2024051075
12110	20643169880676	2024060529
12110	20643169880676	2024080465
12110	20643169880676	2024090470
12110	20643169880676	202312C204
12110	20643169880676	202403C146
12110	20643169880676	202409C128
12110	20643169880676	2023120710
12110	20643169880676	2024011204
12110	20643169880676	2024020140
12110	20643169880676	2024020475
12110	20643169880676	2024030834
12110	20643169880676	2024050403
12110	20643169880676	2024051076
12110	20643169880676	2024070340
12110	20643169880676	2024080690
12110	20643169880676	2024090471
12110	20643169880676	202312C205
12110	20643169880676	202405C079
12110	20643169880676	2023120711
12110	20643169880676	2024020135
12110	20643169880676	2024020141
12110	20643169880676	2024020806
12110	20643169880676	2024030835
12110	20643169880676	2024050404
12110	20643169880676	2024051265
12110	20643169880676	2024071120
12110	20643169880676	2024081023
12110	20643169880676	2024090767
12110	20643169880676	202401C295
12110	20643169880676	202405C080
12110	20643169880676	2023120712
12110	20643169880676	2024020136
12110	20643169880676	2024020471
12110	20643169880676	2024030359
12110	20643169880676	2024031088
12110	20643169880676	2024050761
12110	20643169880676	2024060283
12110	20643169880676	2024071121
12110	20643169880676	2024081024
12110	20643169880676	2024090768
12110	20643169880676	202401C296
12110	20643169880676	202406C064
12110	20643169880676	2023121041
12110	20643169880676	2024020137
12110	20643169880676	2024020472
12110	20643169880676	2024030360
12110	20643169880676	2024050074
12110	20643169880676	2024050762
12110	20643169880676	2024060284
12110	20643169880676	2024071122
12110	20643169880676	2024090228
12110	20643169880676	2024100621
12110	20643169880676	202403C144
12110	20643169880676	202406C065
12113	20643169881338	2023051188
12113	20643169881338	2023070147
12113	20643169881338	2023070979
12113	20643169881338	2023081132
12113	20643169881338	2023090675
12113	20643169881338	2023100243
12113	20643169881338	2023101365
12113	20643169881338	2023121250
12113	20643169881338	2024010470
12113	20643169881338	2024010476
12113	20643169881338	2024031095
12113	20643169881338	2024040245
12113	20643169881338	202310C057
12113	20643169881338	202403C086
12113	20643169881338	2023060142
12113	20643169881338	2023070148
12113	20643169881338	2023080156
12113	20643169881338	2023081547
12113	20643169881338	2023090979
12113	20643169881338	2023100244
12113	20643169881338	2023101366
12113	20643169881338	2023121251
12113	20643169881338	2024010471
12113	20643169881338	2024010477
12113	20643169881338	2024040067
12113	20643169881338	2024060793
12113	20643169881338	202310C058
12113	20643169881338	202403C087
12113	20643169881338	2023060144
12113	20643169881338	2023070149
12113	20643169881338	2023080797
12113	20643169881338	2023081548
12113	20643169881338	2023090980
12113	20643169881338	2023100641
12113	20643169881338	2023110247
12113	20643169881338	2023121252
12113	20643169881338	2024010472
12113	20643169881338	2024011016
12113	20643169881338	2024040068
12113	20643169881338	202307C112
12113	20643169881338	202311C003
12113	20643169881338	202406C057
12113	20643169881338	2023060431
12113	20643169881338	2023070150
12113	20643169881338	2023080798
12113	20643169881338	2023090234
12113	20643169881338	2023091104
12113	20643169881338	2023100642
12113	20643169881338	2023110308
12113	20643169881338	2023121253
12113	20643169881338	2024010473
12113	20643169881338	2024011214
12113	20643169881338	2024040069
12113	20643169881338	202308C248
12113	20643169881338	202312C203
12113	20643169881338	202407C109
12113	20643169881338	2023060762
12113	20643169881338	2023070151
12113	20643169881338	2023081130
12113	20643169881338	2023090235
12113	20643169881338	2023091105
12113	20643169881338	2023101024
12113	20643169881338	2023110312
12113	20643169881338	2023121254
12113	20643169881338	2024010474
12113	20643169881338	2024031093
12113	20643169881338	2024040070
12113	20643169881338	202308C249
12113	20643169881338	202402C086
12113	20643169881338	2023061146
12113	20643169881338	2023070490
12113	20643169881338	2023081131
12113	20643169881338	2023090427
12113	20643169881338	2023091106
12113	20643169881338	2023101025
12113	20643169881338	2023121249
12113	20643169881338	2023121255
12113	20643169881338	2024010475
12113	20643169881338	2024031094
12113	20643169881338	2024040071
12113	20643169881338	202309C022
12113	20643169881338	202403C085
12115	20643169880935	2023051189
12115	20643169880935	2023080157
12115	20643169880935	2023081134
12115	20643169880935	2023091108
12115	20643169880935	2023101027
12115	20643169880935	2023111701
12115	20643169880935	2023120179
12115	20643169880935	2024010196
12115	20643169880935	2024010202
12115	20643169880935	2024011220
12115	20643169880935	202307C113
12115	20643169880935	202312C207
12115	20643169880935	202403C101
12115	20643169880935	2023060145
12115	20643169880935	2023080407
12115	20643169880935	2023081549
12115	20643169880935	2023100097
12115	20643169880935	2023101367
12115	20643169880935	2023111702
12115	20643169880935	2023120719
12115	20643169880935	2024010197
12115	20643169880935	2024011215
12115	20643169880935	2024011221
12115	20643169880935	202308C250
12115	20643169880935	202312C208
12115	20643169880935	202403C102
12115	20643169880935	2023060432
12115	20643169880935	2023080408
12115	20643169880935	2023090236
12115	20643169880935	2023100098
12115	20643169880935	2023101368
12115	20643169880935	2023111703
12115	20643169880935	2023121046
12115	20643169880935	2024010198
12115	20643169880935	2024011216
12115	20643169880935	2024030367
12115	20643169880935	202309C023
12115	20643169880935	202401C008
12115	20643169880935	202406C058
12115	20643169880935	2023061147
12115	20643169880935	2023080799
12115	20643169880935	2023090429
12115	20643169880935	2023100643
12115	20643169880935	2023110168
12115	20643169880935	2023120176
12115	20643169880935	2023121256
12115	20643169880935	2024010199
12115	20643169880935	2024011217
12115	20643169880935	2024030368
12115	20643169880935	202311C008
12115	20643169880935	202402C087
12115	20643169880935	202406C059
12115	20643169880935	2023070491
12115	20643169880935	2023080800
12115	20643169880935	2023091017
12115	20643169880935	2023100644
12115	20643169880935	2023111663
12115	20643169880935	2023120177
12115	20643169880935	2024010194
12115	20643169880935	2024010200
12115	20643169880935	2024011218
12115	20643169880935	2024030841
12115	20643169880935	202311C009
12115	20643169880935	202402C088
12115	20643169880935	2023070980
12115	20643169880935	2023081133
12115	20643169880935	2023091107
12115	20643169880935	2023101026
12115	20643169880935	2023111700
12115	20643169880935	2023120178
12115	20643169880935	2024010195
12115	20643169880935	2024010201
12115	20643169880935	2024011219
12115	20643169880935	2024030842
12115	20643169880935	202312C206
12115	20643169880935	202403C100

What to Do

Identify and quarantine all unused affected product in your inventory and share this notification with others in your organization.

On August 6, Medtronic sent all affected customers a letter recommending the following actions:

Review your inventory for listed product.
Immediately identify and quarantine all unused, listed product in your inventory.
Return unused, listed product in your inventory to Medtronic by contacting Customer Service at 1-800-854-3570, option 1 then option 4, and referencing this communication to initiate a return and credit of unused product. Your Medtronic sales representative can assist you in the return of affected product as necessary.
Complete the Customer Confirmation Form and email to RS.CFQFCA@medtronic.com. This form must be returned even if you do not have any affected product in your possession.
Please share this notification with others in your organization as appropriate. If product listed above has been forwarded to another facility, please notify the facility of this Medtronic Urgent Medical Device Recall.
Please maintain a copy of this communication in your records.
Although the issue has been corrected for newly manufactured lots, please be aware that Medtronic will have limited product availability for these items over the next few months. If the product is unavailable, you may work with your sales representative to explore potential replacement options that Medtronic can offer. Alternatively, Medtronic will issue a credit note if a suitable replacement is not available.

Check this web page for updates. The FDA is currently reviewing information about this potentially high-risk device issue and will keep the public informed as significant new information becomes available.

Reason for Early Alert

Medtronic stated that they have received reports of the affected product resisting shape retention when being bent. These catheters are intended to be malleable and retain a bend in the shaft.

When identified prior to use, this issue may lead to procedure delay while another cannulae is located. If the issue is not identified prior to use and the clinician uses the cannula, it may lead to abrasion and perforation (cuts). Perforation of critical heart tissue may potentially lead to death if it is complicated, unnoticed, or untreated.

As of July 28, Medtronic has reported three serious injuries and no deaths associated with this issue.

Device Use

This catheter is intended for use in venting the left heart during cardiopulmonary bypass surgery up to six hours or less.

Contact Information

Customers in the U.S. with adverse reactions, quality problems, or questions about this recall should contact Medtronic at rs.structuralheartfieldassurance@medtronic.com or call 1-800-854-3570 and select option 4.

Unique Device Identifier (UDI)

The unique device identifier (UDI) helps identify individual medical devices sold in the United States from distribution to use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified more quickly, and as a result, problems potentially resolved more quickly.

How do I report a problem?

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.