Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1034-2015 — Animas Vibe Insulin Infusion Pump. This product is indicated for continuous subcutaneous infusion of insulin for the treatment of diabetes and has a continuous glucose monitoring feature.

U.S. FDA — Device Enforcement · United States · 2011-09-06 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1034-2015
Date of alert: 2011-09-06
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Animas Corporation
Product category: device
Product type: Devices

Reported risk: Calibration factors in the pump overwritten during a programming step. The force sensor could send a lower signal value to the pump processor, with loss of prime warnings, occlusion alarms and the pump unable to detect a cartridge during the prime sequence. Field action initiated 8/29/2011.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

Recall Z-1034-2015 — Animas Vibe Insulin Infusion Pump. This product is indicated for continuous subcutaneous infusion of insulin for the treatment of diabetes and has a continuous glucose monitoring feature.

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