Enpath Medical, Inc. Enpath Steerable Sheath, model 10775-003, Sterile EO. Single Use Only. Enpath Medical, Inc., 15301 Highway 55 West, Minneapolis, MN 55447, USA. The Enpath Deflectable Catheter is a felexible tipped percutaneous catheter designed for gaining access to the peripheral and coronary systems. The device features adjustable tip geometry through use of a sliding mechanism with locking feature to deflect the catheter. There are two versions of the tool: one with a luer fitting for Tuohy-Borst valv Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Enpath Steerable Sheath, model 10775-003, Sterile EO. Single Use Only. Enpath Medical, Inc., 15301 Highway 55 West, Minneapolis, MN 55447, USA. The Enpath Deflectable Catheter is a felexible tipped percutaneous catheter designed for gaining access to the peripheral and coronary systems. The device features adjustable tip geometry through use of a sliding mechanism with locking feature to deflect the catheter. There are two versions of the tool: one with a luer fitting for Tuohy-Borst valv
Brand
Enpath Medical, Inc.
Lot Codes / Batch Numbers
W34968 and W35440
Products Sold
W34968 and W35440
Enpath Medical, Inc. is recalling Enpath Steerable Sheath, model 10775-003, Sterile EO. Single Use Only. Enpath Medical, Inc., 15301 due to Enpath has become aware that some of the Enpath Medical 8 Fr Steerable sheath devices may have non-conforming hemostasis valves in that the valve can . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Enpath has become aware that some of the Enpath Medical 8 Fr Steerable sheath devices may have non-conforming hemostasis valves in that the valve can leak or the valve was observed to have a small hole.
Recommended Action
Per FDA guidance
Clinical locations were sent an Urgent Medical Device Recall letter dated 09/02/05 from Enpath Medical, Inc. The letter states the issue, affected lots to be segregated and to discontinue use of. A Bard Electrophysiology Territory Manager will retrieve affected product.
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 noticeDistribution
As reported by FDA
MA
Page updated: Jan 10, 2026