LivaNova Perfusion Tube Sets Recalled for Potential Sterile Barrier Breach
LivaNova is recalling Perfusion Tube Sets because included Medtronic display sets may have packaging pinholes, creating a potential sterile barrier breach.
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: The recall involves a potential sterile barrier breach in a medical device, which is a risk-of-harm product where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
LivaNova is recalling specific Perfusion Tube Sets (PTS) because they include Medtronic DLP Pressure Disposable Display Sets packaged in pouches that may contain small pinholes. These pinholes, approximately 1mm or less in diameter, may result in a potential sterile barrier breach in the display sets.
The affected products are the SORIN GROUP SMART PERFUSION PACK, INSPIRE 6FS, REF 044008204, STERILE EO, Rx Only. A total of 52 units were distributed nationwide. The recall involves specific lot numbers: 1626400126, 1628100032, 1631900034, 1632800034, 1703300043, 1707400063, 1708000042, 1710000040, and 1716500018.
Healthcare providers and facilities should check their inventory for these specific lot numbers and stop using the affected products. The recall is being conducted by Sorin Group USA, Inc. (LivaNova).
The recalled product
- Product
- SORIN GROUP, SMART PERFUSION PACK, INSPIRE 6FS, REF 044008204, STERILE EO, Rx Only, 1 EA
- Manufacturer
- Sorin Group USA, Inc.
- Affected units
- 52
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 (9)
- Lot Numbers: 1626400126
- 1628100032
- 1631900034
- 1632800034
- 1703300043
- 1707400063
- 1708000042
- 1710000040
- 1716500018
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 16 recalled by Sorin Group USA, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 16 products in this recall →Related recalls
Same manufacturer · Sorin Group USA, Inc.
See all →- HighSorin FlexFlow Venous Cannula Recalled for Sharpness Defect
FDA (Devices) · 2017-11-15
- HighSorin Group Aortic Arch Cannula Recalled for Excess Plastic on Tip
FDA (Devices) · 2017-08-16
- HighLivaNova Perfusion Tube Sets Recalled Due to Potential Sterile Barrier Breach
FDA (Devices) · 2017-08-09
- HighLivaNova Perfusion Tube Sets Recalled for Potential Sterile Barrier Breach
FDA (Devices) · 2017-08-09
- HighLivaNova Perfusion Tube Sets Recalled for Potential Sterile Barrier Breach
FDA (Devices) · 2017-08-09
Same hazard · sterile barrier breach
See all →- ModerateBoston Scientific Radial Jaw 4 Biopsy Forceps Recalled Due to Sterile Barrier Breach Risk
FDA (Devices) · 2026-08-12
- HighBiopsy Forceps Recall: Sterile Packaging Breach Risk
FDA (Devices) · 2026-08-12
- SevereRadial Jaw 4 Jumbo Biopsy Forceps Packaging Sterile Barrier Recall
FDA (Devices) · 2026-08-12
- ModeratePhantom Hindfoot Guide Rods Recalled Due to Sterile Barrier Breaches
FDA (Devices) · 2026-07-29
- HighMedtronic DLP Retrograde Cannula 15FR Model 94665 Sterile Barrier
FDA (Devices) · 2026-05-27