CLASS II Device recall · Reported 20 May 2020 · FDA Enforcement Report
TandemHeart pump is assembled into kits: TandemLung Kit - DL31 recalled
Cardiac Assist is recalling TandemHeart pump is assembled into kits: TandemLung Kit - DL31, distributed nationwide in the US. The recall was initiated on 6 Mar 2020 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1954-2020
- FDA event ID
- 85322
- Recalling firm
- Cardiac Assist, Pittsburgh, PA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 6 Mar 2020
- FDA classified
- 11 May 2020
- Reported
- 20 May 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Heart & Vascular Devices
Timeline
| 6 Mar 2020 | Recall initiated by company | |
| 11 May 2020 | Classified by FDA | +66 days |
| 20 May 2020 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failure to prime due to an assembly error
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
TandemHeart pump is assembled into kits: TandemLung Kit - DL31, Product: 5730-3118 - Product Usage: provides temporary extracorporeal circulatory system support with the unique ability to locally deliver an anticoagulant through the infusion system.
Where it was distributed
US Nationwide distributions.
Questions about this recall
Why was it recalled?
Failure to prime due to an assembly error
Which lots are affected?
Serial Numbers: 00142473 00142606
Where was it sold?
US Nationwide distributions.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
7 other products · FDA event 85322More recalls from Cardiac Assist
All 14| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | LifeSPARC Pump recalled by Cardiac Assist | Cardiac Assist | Device Malfunction | Nationwide |
| Device | CLASS I | Ship Kit, Lifesparc, Controller And Accessories recalled | Cardiac Assist | Device Malfunction | Nationwide |
| Device | CLASS I | Tandem Life LivaNova Lifesparc Controller recalled by Cardiac Assist | Cardiac Assist | Device Malfunction | Nationwide |
| Device | CLASS III | Ship Kit, Procedure Kit, Protekduo LS - DL31 recalled by Cardiac Assist | Cardiac Assist | Packaging Defects | 4 states |
| Device | CLASS II | Protek Solo Venous Dilator Set: dilator, vessel recalled | Cardiac Assist | Packaging Defects | Nationwide |
Other Heart & Vascular Devices recalls
All 6,199| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Getinge PVC Thoracic Catheter, Soft PVC Right Angle recalled | Atrium Medical | Potency & Assay | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes: *Bardex¿ I.C recalled | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Getinge PVC Thoracic Catheter, Firm PVC Straight recalled | Atrium Medical | Potency & Assay | Nationwide |