Enpath Medical, Inc. Channel Steerable Sheath in 8F Enpath part # 10775-003, BARD Part Number XD10775003 (US Distribution Only) and 9F Enpath part # 10775-004 (foreign distribution), BARD Part Number XD10775004; Labeled as Distributed by Bard Electrophysiology Division. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Channel Steerable Sheath in 8F Enpath part # 10775-003, BARD Part Number XD10775003 (US Distribution Only) and 9F Enpath part # 10775-004 (foreign distribution), BARD Part Number XD10775004; Labeled as Distributed by Bard Electrophysiology Division.
Brand
Enpath Medical, Inc.
Lot Codes / Batch Numbers
Model # 8F: Enpath Part Number 10775-003, BARD Part Number XD10775003 (Distributed in US and Internationally). 8F Lots #s W34968 (80 units), W35440 (35 units), W35522 (40 units), W35705 (17 units, sent as SAMPLES, labeled NOT FOR HUMAN USE), W35719 (320 units), W35952 (79 units), W37292 (300 units), W37567 (116 units), W38340 (298 units), W38341 (87 units), W38342 (87 units), W38974 (99 units), W38975 (100 units), W39174 (100 units), W40410 (100 units), W40479 (87 units), W40480 (85 units), W40481 (100 units), W40483 (87 units). Model # 9F: Enpath Part Number 10775-004 (9F), BARD Part Number XD10775004, (Distributed Internationally (EU) only), 9F lot #s, W36392 (3 units), W36623 (5 units), W36884 (2 units), W36974 (8 units).
Products Sold
Model # 8F: Enpath Part Number 10775-003, BARD Part Number XD10775003 (Distributed in US and Internationally). 8F Lots #s W34968 (80 units), W35440 (35 units), W35522 (40 units), W35705 (17 units, sent as SAMPLES, labeled NOT FOR HUMAN USE), W35719 (320 units), W35952 (79 units), W37292 (300 units), W37567 (116 units), W38340 (298 units), W38341 (87 units), W38342 (87 units), W38974 (99 units), W38975 (100 units), W39174 (100 units), W40410 (100 units), W40479 (87 units), W40480 (85 units), W40481 (100 units), W40483 (87 units). Model # 9F: Enpath Part Number 10775-004 (9F), BARD Part Number XD10775004, (Distributed Internationally (EU) only), 9F lot #s; W36392 (3 units), W36623 (5 units), W36884 (2 units), W36974 (8 units).
Enpath Medical, Inc. is recalling Channel Steerable Sheath in 8F Enpath part # 10775-003, BARD Part Number XD10775003 (US Distribution due to Enpath has become aware that some of the Enpath Medical 8F & 9F Steerable sheath devices may have a non-conforming flushport bond that causes a leak w. 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 8F & 9F Steerable sheath devices may have a non-conforming flushport bond that causes a leak where air may enter the flush port chamber.
Recommended Action
Per FDA guidance
Enpath''s three Distributors were notified via letter or telephone on June 27th, 29th and July 6th with a description of the problem and further distribution or use of any remaining product should cease immediately. Instructed to notify their customers about the product and forward to Enpath for evaluation.
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
CA, MA
Page updated: Jan 10, 2026