Z-2554-2011

804115, Terumo Coronary Ostia cannula, 10 Fr, 10 (25 cm) long A cardiopulmonary bypass vascular catheter...

Name: Z-2554-2011 804115, Terumo Coronary Ostia cannula, 10 Fr, 10 (25 cm) long A cardiopulmonary bypass vascular catheter...
Creator: Terumo Cardiovascular Systems Corporation
Published: 2011-05-16
License: https://open.fda.gov/license/

Terumo Cardiovascular Systems Corporation / initiated 2011-05-16 / Terminated / root cause: manufacturing process

FDA source

Terumo Cardiovascular Systems Corporation began a recall of 804115, Terumo Coronary Ostia cannula, 10 Fr, 10 (25 cm) long A cardiopulmonary bypass vascular catheter, cannula, or tubing is a device used in... on 2011-05-16. The reason FDA records is "Terumo has discovered several instances of adhesive build-up and or skiving of plastic (plastic flash) inside the distal tip of the Terumo Coronary Ostia Cannula. The defect was discovered during in-house inspection...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2554-2011
Status: Terminated
Initiated: 2011-05-16
Posted: 2011-06-14
Terminated: 2012-03-21
Recalling firm: Terumo Cardiovascular Systems Corporation
Product: 804115, Terumo Coronary Ostia cannula, 10 Fr, 10 (25 cm) long A cardiopulmonary bypass vascular catheter, cannula, or tubing is a device used in cardiopulmonary surgery to cannulate the vessels, perfuse the coronary arteries, and to interconnect the catheters and cannulas with an oxygenator. The device includes accessory bypass equipment.
Product code: DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Reason for recall: Terumo has discovered several instances of adhesive build-up and or skiving of plastic (plastic flash) inside the distal tip of the Terumo Coronary Ostia Cannula. The defect was discovered during in-house inspection after Terumo CVS implemented a new inspection process for the cannula. There have been no reports of the defect in clinical use.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Terumo Cardiovascular Systems Corporation sent an URGENT MEDICAL DEVICE REMOVAL notice dated May 16, 2011, to all affected customers. The notice identified the product, the problem, and the action to be taken. The letter described the problem, the potiential hazard, and the action to be taken by the consignee. Consignees were instructed to discontinue use of the product and return all product to Terumo. The letter provided a list of alternate products to be used instead of the recalled products. Consignees with questions should call 1-800-521-2818 Monday through Friday 8AM to 6PM.
Quantity in commerce: 900
Distribution: Worldwide Distribution - USA (nationwide) and the countries of BELGIUM, BRAZIL, DOMINICAN REPUBLIC, UNITED ARAB EMIRATES (UAE), SINGAPORE, MALAYSIA, AND SOUTH AFRICA.
Product codes and lots: Part Number 804115 lot 0520497, 0528973, 0569610, 0606841.

Product code DWF

K822210Class IISarns Cardioplegia Cannulae (Var. Types3M Health Care, Sarns / cleared 1982-08-24

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)