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Terminated

Synchromed II infusion pump

FDA Recall Z-1040-04 · Posted 2004-07-20

Recalling FirmMedtronic Inc, Neurological & Spinal Division
Recall StatusTerminated
Product CodeFRN
Date Initiated2004-05-11
Date Terminated2005-11-23
Product Quantity14

Reason for Recall

The opposite version serial numbers were assigned to 20mL and 40mL SynchroMed II Model 8637 pumps. This size-type indication is used by the programmer to identify the pump size and can cause a limitation in the useable fill volume on a 40 mL pump and could cause some confusion related to the size of a 20 mL pump which identifies itself as a 40 mL pump.

Firm Action

The physicians have been notified via letter of the problem with the pump. Appointments will be made with the patients and a Medtronic representative to correct the implanted devices.

Root Cause

Other

Distribution Pattern

Within the United States and outside the United States.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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