Z-1734-2015Class II

AccuChek Spirit insulin infusion pump

Name: Z-1734-2015 AccuChek Spirit insulin infusion pump
Creator: Roche Diabetes Care, Inc.
Published: 2015-04-22
License: https://open.fda.gov/license/

Roche Diabetes Care, Inc. / initiated 2015-04-22 / Terminated / root cause: design

FDA source

Roche Diabetes Care, Inc. began a recall of AccuChek Spirit insulin infusion pump on 2015-04-22. FDA classified it as Class II and gives the reason as "Roche has become aware of an increase of mechanical errors experienced by customers using the Accu-Chek Spirit Combo insulin infusion pump and Accu-Chek Spirit insulin infusion pump when the insulin pumps display E6 and...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1734-2015
Classification: Class II
Status: Terminated
Initiated: 2015-04-22
Posted: 2015-06-09
Terminated: 2016-11-03
Recalling firm: Roche Diabetes Care, Inc.
Product: AccuChek Spirit insulin infusion pump.
Product code: LZG Pump, Infusion, Insulin
Reason for recall: Roche has become aware of an increase of mechanical errors experienced by customers using the Accu-Chek Spirit Combo insulin infusion pump and Accu-Chek Spirit insulin infusion pump when the insulin pumps display E6 and El0 error messages. If the user does not act upon the E6 and E10 error messages appropriately, insulin delivery will be stopped and if unnoticed may lead to severe hyperglycemia u
Root cause tag: design
FDA root cause: Device Design
Action: Roche sent an URGENT MEDICAL DEVICE CORRECTION notification dated April 22, 2015, to all affected customers. The letter identified the problem the product and the action needed to be taken by the customer. The recall notification included a description of the reason for the recall, customer responsibilities, training chart, and instructions for responding to the formal recall notification. Please contact the ACCU-CHEK Customer Care Service Center, 24 hours a day, seven days a week at 1-800-688-4578, if you have questions about the information contained in this notification.
Quantity in commerce: 35,795
Distribution: Nationwide Distribution
Product codes and lots: All Serial Numbers Models: 1. 05458544001, Accu-Chek Combo Kit mg US/English version. 2. 05504686001, Accu-Chek Combo Kit mg US/Spanish version. 3. 05391512001, Accu-Chek Spirit Combo Replacement Pump US/EN. 4. 05391750001, Accu-Chek Spirit Combo Demo Pump US. 5. 04759702001, Accu-Chek Spirit Pump Kit US/CA Back Up. 6. 04540492001, Accu-Chek Spirit Pump Kit US/CA. 7. 04759729001, Accu-Chek Spirit Replacement Pump.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1734-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1733-2015	Class II	Terminated	Voluntary: Firm initiated	2015-06-17	2015-06-09
Z-1734-2015	Class II	Terminated	Voluntary: Firm initiated	2015-06-17	2015-06-09

Product code LZG

K042887Class IIAccu-Chek SpiritDisetronic Medical Systems AG / cleared 2005-03-18

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)