Insulin pumps recalled over malfunction that stops insulin delivery and alerts

Plain-English summary

Battery operated t:slim X2 infusion pumps are being recalled across a wide range of references, including REF 1000911 (t:slim X2 G5 replacement refurbished), 1003808 (t:slim X2 G5 Classic replacement refurbished), 1004219 (t:slim X2 Basal-IQ mg/dl), 1004484 (clinical use only), 1005611, 1005613, 1005615 and 1005617 (Control-IQ variants), 1006379 (Basal-IQ 6.4 refurbished replacement) and 1006402 and 1006406 (Control-IQ 7.4). The recall covers 171,750 units distributed in the United States including Puerto Rico and in more than 20 other countries.

Insulin pumps manufactured with speakers from Revision A and B may experience a malfunction identified as "Malfunction 16". The manufacturer states this prevents audible alerts and causes the pumps to become inoperable and stop infusing insulin, which could result in a hyperglycemic event that may lead to injury and/or hospitalization. The FDA classified the action as Class I, its most serious category.

Pump users should check their pump against the recall notice and follow the manufacturer's instructions, keeping a backup insulin delivery method available. Anyone whose pump has stopped delivering insulin should contact their healthcare provider.

The recalled product

Product

Battery Operated infusion pumps. t:slim X2 G5, Replacement, Refurbished, REF: 1000911; t:slim X2 GS Classic, Replacement, Refurbished, REF: 1003808; t: slim X2, Basal-IQ, mg/dl, REF: 1004219; Pump, t:slim X2, Clinical Use Only, REF: 1004484; Pump, t:slim X2, Control-IQ, REF:

Manufacturer

Tandem Diabetes Care, Inc.

Category

Medical Device — Insulin Pump

Hazard

• device-malfunction
• insulin-delivery-stop
• alert-failure
• hyperglycemia
• class-i

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Distribution

Distributed nationwide across the United States.

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