Skip to the content

FDA Medical Device Recalls (openFDA)

Medtronic Perfusion Systems: Medtronic DLP Single Stage Venous Cannulae with right angle metal tip, REF 67312

Recall number
Z-3128-2024
Recalling firm
Medtronic Perfusion Systems
Product
Medtronic DLP Single Stage Venous Cannulae with right angle metal tip, REF 67312
Status
Open, Classified
Initiated
2024-07-09
Posted
2024-09-12
Terminated
not on file
Reason
During manufacturing, DLP Single Stage Venous Cannulae - straight tip (Model 66118) was incorrectly placed into a product labeled as DLP Single Stage Venous Cannulae - right angle metal tip (Model 67312).
Root cause
Under Investigation by firm
Action
Medtronic issued an Urgent: Medical Device Recall notice to its consignees on 07/09/2024 via UPS. The notice explained the issue, potential risk, and requested return of the affected device. Those who further distributed the device were directed to share the notice with those to whom the affected product was distributed.
Quantity
290 units
Distribution
Worldwide distribution - US Nationwide and the countries of Cambodia, Greece, Ireland, Italy, Saudi Arabia, Switzerland, United Kingdom, Viet Nam.
Lot, serial or model codes
GTIN 20613994879329, Lot Numbers: 2023090954, 202312C065
510(k) numbers
["K120988"]
PMA numbers
not on file
Product code
DWF
Firm FEI
1000116158
Firm city
Brooklyn Park
Firm state
MN
Firm country
not on file

Where this comes from

Register
FDA Medical Device Recalls (openFDA)
Publisher
U.S. Food and Drug Administration (openFDA)
File
device-recall-0001-of-0001.json.zip
sha256
b87518bfe2e8
Published
2026-09-28
Read
2026-09-29T08:25:23.626Z

Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

Search this register