Roche Recalls Accu-Chek Spirit Insulin Pumps Due to Mechanical Errors
Roche Diabetes Care is recalling Accu-Chek Spirit insulin pumps because mechanical errors may stop insulin delivery, potentially leading to severe hyperglycemia.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk of severe hyperglycemia, which aligns with the rubric criteria for Severe severity (FDA Class II with significant health risk).
Plain-English summary
Roche Diabetes Care, Inc. is recalling 35,795 units of the Accu-Chek Spirit insulin infusion pump and Accu-Chek Spirit Combo insulin infusion pump. The recall is due to an increase in mechanical errors where the pumps display E6 and E10 error messages. These pumps were distributed nationwide.
If users do not act appropriately upon the E6 and E10 error messages, insulin delivery will stop. If this interruption is unnoticed, it may lead to severe hyperglycemia. The affected products include various models of the Accu-Chek Spirit Pump Kit, Combo Kit, and Replacement Pump.
Consumers using these devices should check their serial numbers against the list of affected models provided by the manufacturer. Users should monitor their blood glucose levels closely and contact their healthcare provider if they experience symptoms of high blood sugar or if their pump displays these specific error codes.
The recalled product
- Product
- AccuChek Spirit insulin infusion pump.
- Manufacturer
- Roche Diabetes Care, Inc.
- Category
- Medical Device — Insulin Pump
- Affected units
- 35,795
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 (8)
- 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.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Roche Diabetes Care, 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.
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