Medtronic Perfusion Tubing Packs Recalled for Insufficient or Incomplete Welds
Medtronic is recalling specific lots of BB9G78R8 ECC perfusion system tubing packs due to insufficient or incomplete welds that may compromise device integrity.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device with structural manufacturing defects (incomplete welds) in critical perfusion equipment used during cardiac surgery. The recall is based on the manufacturing defect itself. No patient illnesses or injuries are described in the recall notice. Per the rubric, this fits High (3) severity: risk-of-harm product where injury has not yet been reported.
Plain-English summary
Medtronic Perfusion Systems is recalling the BB9G78R8 Custom Pack ECC Supp (Extracorporeal Circulation Support) perfusion system tubing packs. The affected product is a sterile, prescription medical device used in extracorporeal circulation procedures.
Specific lots of this product may have been manufactured with insufficient or incomplete welds, which could compromise the integrity of the tubing system.
The recalled product (Lot number 221238931, Use By 2022-10-17) was distributed nationwide in Alabama, Arizona, California, Indiana, Kentucky, Massachusetts, Ohio, Tennessee, and Texas. Six tubing packs were distributed under this lot number.
Healthcare providers using this product should immediately discontinue use of the recalled lot and contact Medtronic Perfusion Systems for replacement products and instructions.
The recalled product
- Product
- Medtronic BB9G78R8, Custom Pack BB9G78R8 ECC Supp, Custom Perfusion System, Sterile, Rx.
- Manufacturer
- Medtronic Perfusion Systems
- Hazard
- incomplete-welds
- device-malfunction
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 (3)
- GTIN 00763000387044
- Lot number 221238931
- Use By 2022-10-17
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- 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
- SevereMedline Spinal Trays Recalled Due to Quality and Efficacy Concerns
FDA (Devices) · 2026-06-03
- HighMedline Medical Convenience Kit Recalled: Wrong Syringe Type Inside
FDA (Devices) · 2026-06-03
- SevereMedline Spinal Block Kits Recalled for Data Integrity and Efficacy Issues
FDA (Devices) · 2026-06-03