Z-2002-2011

Sarns Flexible Weighted Sucker in K9 Pack (custom pack), catalog number 63635-01, Sterile and Non-pyrogenic...

Name: Z-2002-2011 Sarns Flexible Weighted Sucker in K9 Pack (custom pack), catalog number 63635-01, Sterile and Non-pyrogenic...
Creator: Terumo Cardiovascular Systems Corporation
Published: 2011-02-25
License: https://open.fda.gov/license/

Terumo Cardiovascular Systems Corporation / initiated 2011-02-25 / Terminated / root cause: design

FDA source

Terumo Cardiovascular Systems Corporation began a recall of Sarns Flexible Weighted Sucker in K9 Pack (custom pack), catalog number 63635-01, Sterile and Non-pyrogenic. Sterilized by ethylene oxide. Terumo... on 2011-02-25. The reason FDA records is "The firm has received two reports of the Terumo Weighted Flexible Sucker becoming ensnared in cardiac tissue after it was inserted into a ventricle through a valve. The firm has determined that the products's...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2002-2011
Status: Terminated
Initiated: 2011-02-25
Posted: 2011-04-15
Terminated: 2012-12-10
Recalling firm: Terumo Cardiovascular Systems Corporation
Product: Sarns Flexible Weighted Sucker in K9 Pack (custom pack), catalog number 63635-01, Sterile and Non-pyrogenic. Sterilized by ethylene oxide. Terumo Cardiovascular Systems, Ashland, MA . The Sarns weighted sucker is indicated for stationary use to remove excess fluid from the surgical field.
Product code: GCY Apparatus, Suction, Single Patient Use, Portable, Nonpowered
Reason for recall: The firm has received two reports of the Terumo Weighted Flexible Sucker becoming ensnared in cardiac tissue after it was inserted into a ventricle through a valve. The firm has determined that the products's instructions for use are inadequate; the product should not be used to drain a cardiac chamber or inserted through a valve. However this is not stated in the IFU. The firm is conducting
Root cause tag: design
FDA root cause: Device Design
Action: SEE UPDATE BELOW IN ALL CAPS. The firm, Terumo Cardiovascular Systems (Terumo CVS), sent an "URGENT MEDICAL DEVICE RECALL" letter dated February 25, 2011 to its customers. The letter described the product, problem and actions to be taken. The customers were informed that the product's Indications For Use (IFU) are inadequate; the product should not be used to drain a cardiac chamber or inserted through a valve. However, this is not stated in the IFU. In addition, the customers were instructed to read and understand the changes and clarifications to the product's IFU; review the Medical Device Correction notice; assure that all users are aware of this notice, and confirm receipt of this communication by faxing the attached Customer Response Form via fax to: Terumo CVS Customer Service at 800-292-6551 (US only). If you have any questions or concerns, contact Terumo CVS Customer Service at 1-800-521-2818. Customers Service hours: Monday-Friday, 8AM-6PM. ON 8/30/2011 THE FIRM ISSUE A LETTER ENTITLED "URGENT MEDICAL DEVICE RECALL" THAT STATED "AFTER FURTHER CONSIDERATION, TERUMO CVS DECIDED TO DISCONTINUE SALES OF THE WEIGHTED FLEXIBLE SUCKER AND IS ASKING USERS TO RETURN ALL UNUSED PRODUCT" TO THE FIRM.
Quantity in commerce: 11,690
Distribution: Worldwide distribution: USA (Nationwide) and countries including: BRAZIL, BELGIUM, BRAZIL, DOMINICAN REPUBLIC, UNITED ARAB EMIRATES, and MALAYSIA.
Product codes and lots: Lot number LK17

Product code GCY

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)