Roche Diagnostics Corp. Disetronic H-TRON V100 Insulin Pump; catalog # 8010030C [clear case] and 8010030 [solid-color case] Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Disetronic H-TRON V100 Insulin Pump; catalog # 8010030C [clear case] and 8010030 [solid-color case]
Brand
Roche Diagnostics Corp.
Lot Codes / Batch Numbers
All units.
Products Sold
All units.
Roche Diagnostics Corp. is recalling Disetronic H-TRON V100 Insulin Pump; catalog # 8010030C [clear case] and 8010030 [solid-color case] due to Lack of assurance of reliability, due to quality system regulations violations, plus notice to users not to expose pump to water.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Lack of assurance of reliability, due to quality system regulations violations, plus notice to users not to expose pump to water.
Recommended Action
Per FDA guidance
An urgent product correction and removal letter dated 7/16/03 was issued to each pump user informing of potential problems with the pump and instructing them how to proceed if they wish to discontinue use of the pump, have it replaced, or have questions regarding the pump.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026