LivaNova Perfusion Tube Sets Recalled for Potential Sterile Barrier Breach
LivaNova is recalling Perfusion Tube Sets because the included Medtronic display sets may have 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 poses a risk of harm (infection) even though no specific injuries or illnesses are reported in the source text.
Plain-English summary
LivaNova is recalling Perfusion Tube Sets (PTS) because they are distributed with Medtronic DLP Pressure Disposable Display Sets that may be packaged in pouches with small pinholes. These pinholes, approximately 1mm or less in diameter, may result in a potential sterile barrier breach in the display sets.
The recall involves 50 units of the SORIN GROUP SMART PERFUSION PACK, LONG PACK, REF 088512600, STERILE EO, Rx Only, 1 EA. The affected lot numbers are 1625200040, 1635400048, 1704700039, 1706700087, 1711400055, and 1717200038. The products were distributed nationwide.
Healthcare providers and patients should stop using the affected Perfusion Tube Sets and contact LivaNova or their supplier for further instructions.
The recalled product
- Product
- SORIN GROUP, SMART PERFUSION PACK, LONG PACK, REF 088512600, STERILE EO, Rx Only, 1 EA
- Manufacturer
- Sorin Group USA, Inc.
- Affected units
- 50
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 (6)
- Lot Numbers: 1625200040
- 1635400048
- 1704700039
- 1706700087
- 1711400055
- 1717200038
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 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
- HighLivaNova Perfusion Tube Sets Recalled Due to 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