FDA Medical Device Recalls (openFDA)
Medtronic Perfusion Systems: Medtronic DLP Coronary Ostial Cannulae, Model Number 30050
- Recall number
- Z-1795-2024
- Recalling firm
- Medtronic Perfusion Systems
- Product
- Medtronic DLP Coronary Ostial Cannulae, Model Number 30050
- Status
- Open, Classified
- Initiated
- 2024-03-19
- Posted
- 2024-05-10
- Terminated
- not on file
- Reason
- Potential for unsealed sterile packing.
- Root cause
- Process control
- Action
- Medtronic 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
- 250 units
- Distribution
- Worldwide distribution.
- Lot, serial or model codes
- GTIN 00613994576019, Lot Numbers: 2023070529; GTIN 20613994576013, Lot Numbers: 2023070529
- 510(k) numbers
- ["K131269"]
- 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
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
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