Heartport Inc Route Introducer Sheath is indicated for patients requiring introduction of catheters. Introducer Sheath for EndoClamp, aortic catheter, 19Fr. IS19 (07042). Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Introducer Sheath is indicated for patients requiring introduction of catheters. Introducer Sheath for EndoClamp, aortic catheter, 19Fr. IS19 (07042).
Brand
Heartport Inc Route
Lot Codes / Batch Numbers
Lot number 020374
Products Sold
Lot number 020374
Heartport Inc Route is recalling Introducer Sheath is indicated for patients requiring introduction of catheters. Introducer Sheath due to Damaged hemostasis valves that prevent or present difficulty when inserting catheters.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Damaged hemostasis valves that prevent or present difficulty when inserting catheters.
Recommended Action
Per FDA guidance
Recall was first initiated on/about 10/2/03 by phone domestically from the Director of Marketing to the firm''s Sales Force (no phone script available). Following the initial phone call, formal recall letters were sent out on 10/6/03 to: Director of CV Suite; Director of the OR; and Director of Material Management of each hospital.
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, FL, GA, IN, MD, MI, MN, MO, NJ, NY, NC, OH, PA, SC, TN, TX, VA, WA, WI, DC
Page updated: Jan 10, 2026