LifePort® Kidney Transporter LKT101PRecalls & reported problems
Organ Recovery Systems, Inc. · LifePort® Kidney Transporter 1.1 · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00815045020018), received between Aug 6, 2026 and Sep 16, 2026 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “No Display/Image” (1 report).
1 other recall cover devices cleared under the same FDA submission (K021362); they may or may not involve this specific model.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- No Display/Image1
- Unexpected Shutdown1
- Use of Device Problem1
Patient problems
- Insufficient Information2
- Unspecified Vascular Problem1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjurySep 16, 2026Use of Device Problem
Patient problems: Insufficient Information
MAUDE report 50794355 ↗InjuryAug 11, 2026Unexpected Shutdown
LifeSource - Upper Midwest Organ Procurement Organization, based in (b)(6), reported that a LifePort Kidney Transporter (LKT101P) malfunctioned during air transport of a donor kidney. Upon landing, customer observed a pressure alarm and reported that the LKT101P stopped pumping/perfusing the donor kidney. The donor kidney (UNOS IS (b)(6) remained in cold storage after perfusion ceased. The transplant surgeon declined the donor kidney due to evidence of petechiae on the kidney and the LKT101P malfunction.
Patient problems: Insufficient Information
MAUDE report 50201323 ↗MalfunctionAug 6, 2026No Display/Image
Patient problems: Unspecified Vascular Problem
MAUDE report 50159197 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K021362. One submission often covers many models, so check the product and lot details in each record.
- Z-1437-2020 · Jan 30, 2020 · TerminatedLKT200 Perfusion Circuit, part of Lifeport Kidney Perfusion Transporter KTR - Product Usage: The circuit is an accessory to LifePort Kidney Perfusion Transporter (KTR) Isolated kid
Other System, Perfusion, Kidney devices
- KidneyVault PRGNX-8008-001Paragonix Technologies Inc · System, Perfusion, Kidney1 recall2 reports
- Belzer UW Cold Storage Solution BUW-500Preservation Solutions Inc · System, Perfusion, Kidney1 recall0 reports
- Custodiol(R) 10 x 500 mlDr. Franz Köhler Chemie GmbH · System, Perfusion, Kidney1 recall0 reports
- Belzer UW Cold Storage Solution BUW-002Preservation Solutions Inc · System, Perfusion, Kidney1 recall0 reports
- Waters IGL Cold Storage Solution CSS/2000/USPreservation Solutions Inc · System, Perfusion, Kidney1 recall0 reports
- EasiSlush BTLE-1250Bridge To Life Ltd. · System, Perfusion, Kidney1 recall0 reports
- Perfadex with THAM 19018Xvivo Perfusion AB · System, Perfusion, Kidney1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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