Z-2911-2016Class II

Walrus Arterial Embolectomy Catheter The arterial embolectomy catheter is intended for use in removing...

Name: Z-2911-2016 Walrus Arterial Embolectomy Catheter The arterial embolectomy catheter is intended for use in removing...
Creator: Arrow International Inc
Published: 2016-07-07
License: https://open.fda.gov/license/

Arrow International LLC (subsidiary of Teleflex Incorporated) / initiated 2016-07-07 / Terminated / root cause: design

FDA source

Arrow International Inc began a recall of Walrus Arterial Embolectomy Catheter The arterial embolectomy catheter is intended for use in removing arterial emboli on 2016-07-07. FDA classified it as Class II and gives the reason as "Arrow is recalling due to incorrect labeling of products". 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-2911-2016
Classification: Class II
Status: Terminated
Initiated: 2016-07-07
Posted: 2016-09-30
Terminated: 2017-10-25
Recalling firm: Arrow International LLC (subsidiary of Teleflex Incorporated)
Product: Walrus Arterial Embolectomy Catheter The arterial embolectomy catheter is intended for use in removing arterial emboli.
Product code: DXE Catheter, Embolectomy
Reason for recall: Arrow is recalling due to incorrect labeling of products.
Root cause tag: design
FDA root cause: Component design/selection
Action: The firm, Arrow International, Inc., sent an "Urgent Medical Device Recall Notification" letter dated July 07, 2016 via FedEx to its customers. The letter described the product, problems and actions to be taken. The customers were instructed to immediately discontinue use and quarantine any products they may have on hand; return product, and complete the enclosed Recall Acknowledgement Form and fax it to 1-855-419-8507, Attn: Customer Service or email to [email protected], even if you have no affected stock. If you have any other questions, feel free to contact your local sales representative or Customer Service at 1-866-246-6990.
Quantity in commerce: 2,425 catheters
Distribution: US Nationwide Distribution
Product codes and lots: Lot/Batch 14F15H0292, 14F15J0139, 14F15A0174, CF3016366, 14F14E0300, 14F15G0349, 14F15H0261, CF2079921, 14F15J0363, 14F14J0155, 14F15F0406, 14F15E0263, 14F15H0258, 14F15H0251, 14F15G0347. CF2125865, 14F15D0197, 14F15H0025, 14F15H0332, 14F15B0244, 14F15G0348

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2911-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2911-2016	Class II	Terminated	Voluntary: Firm initiated	2016-10-12	2016-09-30

Product code DXE

K902327Class IIEmbolectomy CatheterClincal Instruments Corp. / cleared 1991-02-25

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)