FDA Medical Device Recalls (openFDA)
Heartport Inc: EndoReturn arterial cannula. The EndoReturn arterial cannula is indicated for patients undergoing cardiopulmonary bypass. The EndoReturn cannula with hemostasis valve allows for hemostatic introduction and removal of the Heartport EndoClamp aortic catheter. EndoReturn arterial cannula, 23 Fr. Product code ER23 (07044).
- Recall number
- Z-0308-04
- Recalling firm
- Heartport Inc
- Product
- EndoReturn arterial cannula. The EndoReturn arterial cannula is indicated for patients undergoing cardiopulmonary bypass. The EndoReturn cannula with hemostasis valve allows for hemostatic introduction and removal of the Heartport EndoClamp aortic catheter. EndoReturn arterial cannula, 23 Fr. Product code ER23 (07044).
- Status
- Terminated
- Initiated
- 2003-10-02
- Posted
- 2004-01-09
- Terminated
- 2005-10-19
- Reason
- Damaged hemostasis valves that prevent or present difficulty when inserting catheters.
- Root cause
- Other
- Action
- 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.
- Quantity
- 209 units
- 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.
- Lot, serial or model codes
- Lot Numbers 020347, 030343, 060338, 080348
- 510(k) numbers
- ["K955121","K971291","K972570","K974736","K990772","K994253"]
- PMA numbers
- not on file
- Product code
- DWF
- Firm FEI
- 3000719637
- Firm city
- Somerville
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28