Device recalls

EOPA Elongated One-Piece Arterial Cannula BLUNT 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Num…

Medtronic Perfusion Systems · Medtronic received reports of pinhole leaks in the wire-wound body of 22 Fr EOPA 3D Arterial Cannulae and EOPA Elongated One-Piece Arterial Cannulae used durin…

Open, ClassifiedUnder Investigation by firmZ-2807-2026
Open FDA's page for this record
Cfres ID
221278
Product res number
Z-2807-2026
Event date initiated
2026-06-24
Event date posted
2026-07-27
Recall status
Open, Classified
Res event number
99320
Product code
DWF
Product description
EOPA Elongated One-Piece Arterial Cannula BLUNT 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 77522
Firm FEI number
1000116158
Recalling firm
Medtronic Perfusion Systems
Address 1
7611 Northland Dr N
City
Brooklyn Park
State
MN
Postal code
55428-1088
Additional info contact
Medtronic Customer Service 391-9001
Root cause description
Under Investigation by firm
Product quantity
11,720 units
Distribution pattern
Worldwide - US Nationwide distribution.
Code info

UDI-DI: 00199150023288, Lot Numbers: 0233286436; UDI-DI: 20199150023282, Lot Numbers: 0232709428 0232744924 0232745061 0232745092 0232798556 0232862763 0232862778 0232862794 0232862798 0232903216 0232903291 0232903383 0232990983 0233286318 0233286414 0233286436 0233427120 0233528730 0233553623 0233556386 0233585113 0233585114 0232670802

Reason for recall

Medtronic received reports of pinhole leaks in the wire-wound body of 22 Fr EOPA 3D Arterial Cannulae and EOPA Elongated One-Piece Arterial Cannulae used during cardiopulmonary bypass procedures.

Action

An URGENT: MEDICAL DEVICE RECALL notification letter dated June 2026 was sent to customers beginning 6/24/26. Customer Actions: Medtronic requests that you take the following actions: " Review your inventory for listed products using Attachment A. " 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 return for credit or replacement product. Your Medtronic sales representative can assist you in the return of affected product as necessary. " Complete the enclosed 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 the 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. If you have any questions regarding this communication, please contact 1-800-854-3570, Option 1, then Option 4.

K numbers
K031037
Harmonized identifiers (openFDA)
Device name
Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Medical specialty description
Cardiovascular
Regulation number
870.4210
Device class
2
K number
K060101, K884393, K113459, K120072, K132451, K874896, K030696, K842889, K890024, K854487, K883981, K012538, K033416, K843444, K902277, K190557, K203057, K810548, K881733, K872762, K850925, K981601, K861322, K100274, K861096, K002019, K870109, K915193, K884310, K881072, K200612, K200358, K872788, K081933, K231206, K810515, K971019, K253106, K801398, K971041 +361 more
Registration number
2184009, 1417592, 2032228, 3009380063, 3016746283, 3021632375, 1723241, 2029275, 1820334, 1519227, 3010017366, 3017540705, 1647149, 3004080795, 1643817, 2020394, 3009493875, 1450662, 1722746, 9617601, 9680721, 3007829657, 1319211, 1123137, 1221051, 3009420598, 3014479313, 1649139, 1424263, 3005941719, 1220648, 1724474, 1000393132, 1929756, 1718850, 1000523114, 9611109, 3003955307, 3030125051, 2320762 +64 more
FEI number
3002406063, 1417592, 3009380063, 3016746283, 3021632375, 1000514656, 1820334, 1519227, 3010017366, 3017540705, 1000123180, 3004080795, 3001665800, 1643817, 1000120613, 2020394, 1000518731, 3009493875, 1450662, 1000112877, 3007829657, 1319211, 1221051, 3009420598, 3003166981, 3014479313, 1220648, 3000215273, 3002807095, 3003015552, 1000393132, 1929756, 1000517719, 1718850, 1000523114, 3003955307, 3030125051, 3005173255, 3003752502, 1000116158 +64 more
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.