Medtronic Implantable Insulin Pump System, REF: MMT-2007D, Sterile EO, CE 0459 UDI: 00763000043001
This recall has been terminated (originally issued June 3, 2020).
- Company
- Medtronic Inc.
- Recall Initiated
- April 10, 2020
- Posted
- June 3, 2020
- Terminated
- April 27, 2021
- Recall Number
- Z-2206-2020
- Quantity
- 24 Pumps
- Firm Location
- Northridge, CA
- Official Source
- View on FDA website ↗
Reason for Recall
Internal testing results showed endotoxin-related test result did not meet specifications for implantable insulin pump. If pumps have higher than allowed endotoxin levels, patients may have an effect of fever, hypotension, anaphylactic shock, hyperglycemia, or diabetic ketoacidosis (DKA), potentially followed by secondary multi-organ failure (primarily renal and hepatic) and/or death.
Distribution
No US Distribution. OUS: Netherlands, France, and Sweden
Lot / Code Info
Device not distributed within the US. All Pump lots produced May 21, 2019 to present containing the following serial numbers: 31359, 31360, and 31332
Root Cause
Process control
Action Taken
Medtronic initiated verbal communication with affected consignees on April 10, 2020 via phone call and provided affected consignees with an "Urgent Field Safety Notice" via email between the dates of 04/24/20 - 4/30/20. . In addition to informing consignees about the recall, the firm asked consignees to take the following actions: 1. Immediately identify and quarantine all unused affected pumps in your inventory. 2. Return all unused affected pumps in your inventory to Medtronic. Your Medtronic Representative can assist you in the return and replacement of this pump as necessary. 3. Forward this notice to all those who need to be aware within your organization and to any organization where the affected pumps may have been transferred. Please maintain a copy of this notice in your records.