Roche Recalls Accu-Chek Spirit Combo Insulin Pumps Due to Mechanical Errors
Roche is recalling Accu-Chek Spirit Combo 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 criterion for Severe (4) involving significant injury reports or high-risk medical device defects.
Plain-English summary
Roche Diabetes Care, Inc. is recalling the Accu-Chek Spirit Combo insulin infusion pump and the Accu-Chek Spirit insulin infusion pump. The recall involves 35,795 units that were distributed nationwide. The affected products include various models of the Accu-Chek Combo Kit, replacement pumps, and demo pumps.
The recall is due to an increase in mechanical errors experienced by customers. These errors are indicated by the display of E6 and E10 error messages on the pump. If users do not act upon these error messages appropriately, the insulin delivery will stop. If this interruption is not noticed by the user, it may lead to severe hyperglycemia.
Consumers using these devices should check their serial numbers against the affected models listed in the recall notice. If the device is affected, users should contact Roche Diabetes Care for instructions on how to proceed.
The recalled product
- Product
- AccuChek Spirit Combo insulin infusion pump sold as part of Accu-Chek Combo System.
- 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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