Introducer Sheath is indicated for patients requiring… recallZ-0311-04 · Heartport Inc · initiated Oct 2, 2003
Terminated All recalls posted in January 2004
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Heartport Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Damaged hemostasis valves that prevent or present difficulty when inserting catheters.
FDA root cause category: Other
What the company is doing
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.
Recall details
- Recall number
- Z-0311-04
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Oct 2, 2003
- Posted by the FDA
- Jan 9, 2004
- Recalling firm
- Heartport Inc
- Quantity
- 13 units
- Product code
- DWF
- FDA submissions
- K955121, K971291, K972570, K974736, K990772, K994253
- Distribution
- Products were distributed domestically to 45 customers in CA, DC, FL, GA, IN, MD, MI, MN, MO, NC, NJ, NY, OH, PA, SC, TN, TX, VA, WA, and WI. The products were also distributed internationally to Israel, Austria, France, Germany, Italy, Belgium, Slovenia, Spain and UK. There was one US government consignment, Veterans Affairs Palo Alto, located at Health Care System, 3801 Miranda Ave. WHSE 50, Palo Alto, CA.
Product description
Introducer Sheath is indicated for patients requiring introduction of catheters. Introducer Sheath for EndoClamp, aortic catheter, 19Fr. IS19 (07042).
Code information (models, lots, serial numbers)
Lot number 020374
Other devices under the same FDA submission
2 devices cleared under K955121, K971291, K972570, K974736, K990772, K994253 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Syringe Kit - Stroke MVSK60Microvention, Inc. · Syringe, piston1 recall0 reports
- ThruPort Systems EndoReturn Arterial Cannula Kit ER21BEdwards Lifesciences LLC · CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS1 report
Other products in the same recall event
The FDA groups related products into one recall event (event 27410).
- Z-0307-04 · TerminatedEndoReturn arterial cannula. The EndoReturn arterial cannula is indicated for patients undergoing cardiopulmonary bypass. The EndoReturn cannula with hemostasis valve allows for …
- Z-0308-04 · TerminatedEndoReturn arterial cannula. The EndoReturn arterial cannula is indicated for patients undergoing cardiopulmonary bypass. The EndoReturn cannula with hemostasis valve allows for …
- Z-0309-04 · TerminatedDirectFlow arterial cannula is intended to deliver oxygenated blood for cardiopulmonary bypass during surgery. The product also allows the hemostatic introduction and removal of t…
- Z-0310-04 · TerminatedSoftClamp II arterial cannula is intended to deliver oxygenated blood for cardiopulmonary bypass during surgery. The product also allows the hemostatic introduction and removal of…
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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