Medical procedure kits recalled for aortic cannula assembly defect
Medline procedure kits with Medtronic aortic root cannulas are recalled for potential excess material in the male lures, affecting 320 units distributed in eight US states.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This recall is classified as FDA Class I by the agency, which establishes a minimum severity level of Severe per the rubric. While no deaths or serious injuries have been reported, the potential defect in critical cardiac equipment warrants this classification.
Plain-English summary
Medline Industries is recalling medical procedure kits labeled HEART BASIN PACK-LF that contain Medtronic Aortic Root Cannulas. The recall was initiated because of potential excess material found in the male lures on the aortic cannula, which could affect proper assembly and use of the device during cardiac procedures.
The recall affects 320 units distributed across California, Florida, Minnesota, New York, Ohio, Oregon, Pennsylvania, Texas, and West Virginia. The affected lot numbers are 24BMB798, 24DMH381, 24EMF949, 24GMF161, and 24IMB237. Healthcare facilities that received these kits should immediately verify their inventory against these lot numbers.
Healthcare facilities in possession of affected units should immediately identify and segregate them, and contact Medline Industries, LP for replacement or disposal guidance.
The recalled product
- Product
- Medline medical procedure kits, containing Medtronic Aortic Root Cannula, labeled as follows: HEART BASIN PACK-LF
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- excess-material
- assembly-defect
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (7)
- HEART BASIN PACK-LF
- UDI/DI 10195327563561 (ea) 40195327563562 (case)
- Lot Numbers 24BMB798
- 24DMH381
- 24EMF949
- 24GMF161
- 24IMB237.
Distribution
Distributed in 9 states:
- CA
- FL
- MN
- NY
- OH
- OR
- PA
- TX
- WV
Related recalls
Same category
- SevereMedline Spinal Block Kits Recalled for Data Integrity and Efficacy Issues
FDA (Devices) · 2026-06-03
- SevereAbiomed Automated Impella Controller recalled for motor control and pump failure risks
FDA (Devices) · 2026-06-03
- HighGE APEXPRO and CARESCAPE Telemetry Systems Risk Loss of Patient Monitoring
FDA (Devices) · 2026-06-03
- CriticalMedline spinal anesthetic kits recalled for quality and efficacy concerns
FDA (Devices) · 2026-06-03
- SevereMedline spinal anesthesia kits recalled for bupivacaine quality issues
FDA (Devices) · 2026-06-03