Z-1953-2020Class II

TandemHeart pump is assembled into kits: ProtekDuo Kit - DL31 RD, Product: 5720-3631 -

Name: Z-1953-2020 TandemHeart pump is assembled into kits: ProtekDuo Kit - DL31 RD, Product: 5720-3631 -
Creator: Cardiac Assist, Inc
Published: 2020-03-06
License: https://open.fda.gov/license/

Cardiac Assist, Inc / initiated 2020-03-06 / Terminated / root cause: manufacturing process

FDA source

Cardiac Assist, Inc began a recall of TandemHeart pump is assembled into kits: ProtekDuo Kit - DL31 RD, Product: 5720-3631 - Product Usage: provides temporary extracorporeal circulatory system... on 2020-03-06. FDA classified it as Class II and gives the reason as "Failure to prime due to an assembly error". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1953-2020
Classification: Class II
Status: Terminated
Initiated: 2020-03-06
Posted: 2020-05-11
Terminated: 2020-11-20
Recalling firm: Cardiac Assist, Inc
Product: TandemHeart pump is assembled into kits: ProtekDuo Kit - DL31 RD, Product: 5720-3631 - Product Usage: provides temporary extracorporeal circulatory system support with the unique ability to locally deliver an anticoagulant through the infusion system.
Product code: KFM Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
Reason for recall: Failure to prime due to an assembly error
Root cause tag: manufacturing process
FDA root cause: Under Investigation by firm
Action: LivaNova dba Tandem Life notified consignees via 1st class mail (certified return receipt) on March 06th, 2020, states reason for recall, health risk, and action to take: Check your inventory for the presence of potentially affected TandemHeart pump contained within your ordered kit as per Table 1 provided in Attachment 1; - Ensure any affected kit containing the potentially affected TandemHeart pump still in inventory gets quarantined before they can be returned. 2. Please fill and return Response Form by email to [email protected] confirm appropriate corrective actions have been executed. Please return the Response Form even if each potentially affected device listed in Attachment 1 has already been used. 3. Potentially affected product still in your inventory will be replaced once the Response Form has been returned to LivaNova. Leverage your TandemLife representativeto aid in the collection of the affected quarantined kit containing the potentially affected TandemHeart pump. Questions regarding this Medical Device Removal, please contact your TandemLife representative, or TandemLife Customer Quality at [email protected].
Quantity in commerce: 6
Distribution: US Nationwide distributions.
Product codes and lots: Serial Numbers: 00142676 00142677 00142678 00142679 00142680 00142910

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1953-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1948-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-20	2020-05-11
Z-1949-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-20	2020-05-11
Z-1950-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-20	2020-05-11
Z-1951-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-20	2020-05-11
Z-1952-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-20	2020-05-11
Z-1953-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-20	2020-05-11
Z-1954-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-20	2020-05-11
Z-1955-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-20	2020-05-11

Product code KFM

K110493Class IITandemheart PumpCardiacassist, Inc. / cleared 2011-09-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)