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U.S. Department of Health and Human Services

Class 2 Device Recall Enpath Steerable Sheath

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  Class 2 Device Recall Enpath Steerable Sheath see related information
Date Initiated by Firm August 31, 2005
Date Posted September 21, 2005
Recall Status1 Terminated 3 on July 22, 2006
Recall Number Z-1573-05
Recall Event ID 33338
510(K)Number K043489  
Product Classification Introducer, Catheter - Product Code DYB
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 valve connection, the other with a hemostasis valve and a sideport infusion line. The kit includes a flexible catheter dilator to facilitate deflectable catheter passage.
Code Information W34968 and W35440
Recalling Firm/
Manufacturer		 Enpath Medical, Inc.
15301 Highway 55
Plymouth MN 55447-1418
For Additional Information Contact James Hartman
763-559-2613
Manufacturer Reason
for Recall		 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.
FDA Determined
Cause 2		 Other
Action 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.
Quantity in Commerce 140
Distribution MA
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = DYB and Original Applicant = ENPATH MEDICAL INCORPORATED
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