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 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
