Tandem Diabetes Care Inc: Medical Device Recall in 2014 - (Recall #: Z-0827-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

T:slim Insulin Delivery System Insulin Infusion Pump

Product Classification:

Class I

Date Initiated: January 10, 2014

Date Posted: February 19, 2014

Recall Number: Z-0827-2014

Event ID: 67264

Reason for Recall:

Specific lots of insulin cartridges that are used with the T:slim Insulin Pump may be at risk for leaking. A cartridge leak could result in the device delivering too much or too little insulin, which can lead to a serious adverse event.

Status: Terminated

Product Quantity: 12, 807 boxes (10packs)

Code Information:

Lot Numbers: M000857, M001414, M001454, M001963, M002028, M000869, M001415, M001455, M001964, M002029, M001344, M001416, M001456, M001973, M002030, M001345, M001417, M001457, M001974, M002082, M001346, M001420, M001458, M001979, M002083, M001347, M001421, M001459, M001980, M002096, M001389, M001422, M001460, M001987, M002097, M001390, M001423, M001528, M001988, M002099, M001391, M001451, M001529, M001990, M002100, M001392, M001452, M001530, M001991, M002119, M001393, M001453, M001532, M002027, M002120.

Distribution Pattern:

USA (nationwide)

Voluntary or Mandated:

Voluntary: Firm initiated