Medtronic Recalls Trellis 6 and 8 Peripheral Infusion Systems for Sterility Breach
Medtronic is voluntarily recalling Trellis 6 and 8 Peripheral Infusion Systems due to potential sterility breaches in the outer packaging.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is a voluntary precautionary recall for a potential packaging defect where the source explicitly states the internal device sterility is not directly affected, fitting the criteria for moderate severity.
Plain-English summary
Medtronic is conducting a voluntary recall of all former Covidien Trellis 6 and Trellis 8 Peripheral Infusion Systems. The recall is due to the potential for a sterility breach of the outer packaging or pouch material.
A breach of the outer pouch may compromise the outside surface sterility of the inner pouch. However, the source text states that this does not directly affect the sterility of the device components within the inner pouch.
The affected products are intended for controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature. The recall covers 8,269 units distributed in the United States and various countries worldwide.
The recalled product
- Product
- Covidien Trellis 6 and Trellis 8 Peripheral Infusion Systems, Sterile EO, Rx only. Models BVT608010V01, BVT608030V01, BVT612010V01, BVT612030V01, CVT808015, CVT808025, CVT812015, CVT812025, EVT808015, EVT808025, EVT812015, EVT812025, BVT808015, BVT808030, BVT812015, BVT812030…
- Manufacturer
- Medtronic Inc. Cardiac Rhythm Disease Management
Distribution
Related recalls
Same manufacturer · Medtronic Inc. Cardiac Rhythm Disease Management
See all →- ModerateMedtronic SureScan Pacemaker ID Cards Mislabel MR Conditional Status
FDA (Devices) · 2015-10-14
- HighMedtronic CryoConsole Recalled Due to USB Component Issue
FDA (Devices) · 2015-09-23
- SevereMedtronic Temporary Pacemaker Recalled for Battery Connection Failure
FDA (Devices) · 2015-04-08
- SevereMedtronic FlexCath Select Steerable Sheath Recalled for Valve Debris
FDA (Devices) · 2015-03-25
- HighMedtronic Temporary Pacemaker Recalled for Pacing Rate Defect
FDA (Devices) · 2014-06-04
Same hazard · sterility breach
See all →- HighMedline Open Heart A Pack Kits Recalled for Sterility Concerns
FDA (Devices) · 2026-09-23
- HighAVID Medical Recalls Halyard IV Start Kits Due to Seal Defects
FDA (Devices) · 2026-09-16
- SevereMedline Ultrasound Breast Pack Recalled for Potential Sterility Breach
FDA (Devices) · 2026-09-09
- SevereMedline C-Section Prep Kits Recalled for Potential Sterility Breach
FDA (Devices) · 2026-09-09
- HighMedline Convenience Kits Recalled for Potential Sterility Breach
FDA (Devices) · 2026-09-09
Similar recalls
- SevereFDA Recalls Covidien Trellis-6 Peripheral Infusion Systems Due to Labeling Error
FDA (Devices) · 2015-02-11
- SevereFDA Recalls Covidien Trellis-8 Peripheral Infusion Systems Due to Labeling Error
FDA (Devices) · 2015-02-11
- HighMedtronic Perfusion Systems Recalls Extra Corporeal Circuits Due to Sterilization Failure
FDA (Devices) · 2020-07-15
- HighMedtronic Perfusion Tubing Packs Recalled for Insufficient or Incomplete Welds
FDA (Devices) · 2021-06-23
- HighMedtronic Cardiotomy Reservoir Recall for Possible Sterile Barrier Breach
FDA (Devices) · 2018-02-28
- HighMedtronic Intracoronary Shunts recalled for potential unsealed sterile packaging
FDA (Devices) · 2024-05-22