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EndoReturn arterial cannula. The EndoReturn arterial… recallZ-0307-04 · Heartport Inc · initiated Oct 2, 2003

Terminated All recalls posted in January 2004

Is my device affected?

  1. 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.
  2. 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.
  3. 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-0307-04
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
376 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

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, 21 Fr. Product code ER21 (07043). The cannulas are also packaged in kits that have no specific lot number. The EndoReturn arterial cannula is packaged in the ''EndoCPB (Cardiopulmonary Bypass) System with Cardioplegia Catheter, Product codes ECPB211, 212, 213, 214, 231, 232. Also, the EndoCPB system without Cardioplegia Catheter, Product codes ECPB211, 212, 231, 232.

Code information (models, lots, serial numbers)

Lot Numbers 020349, 050327, 060337.

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.

Other products in the same recall event

The FDA groups related products into one recall event (event 27410).

Sources and updates

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