Z-1454-2014Class I

Alligator Retrieval Device (ARD). Used in the peripheral and neurovasculature for foreign body removal

Name: Z-1454-2014 Alligator Retrieval Device (ARD). Used in the peripheral and neurovasculature for foreign body removal
Creator: Micro Therapeutics Inc, Dba Ev3 Neurovascular
Published: 2014-04-01
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2014-04-01 / Terminated

FDA source

Micro Therapeutics Inc, Dba Ev3 Neurovascular began a recall of Alligator Retrieval Device (ARD). Used in the peripheral and neurovasculature for foreign body removal on 2014-04-01. FDA classified it as Class I and gives the reason as "Potential for the PTFE (polytetrafluoroethylene) coating to delaminate and detach from the delivery wire". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1454-2014
Classification: Class I
Status: Terminated
Initiated: 2014-04-01
Posted: 2014-04-16
Terminated: 2014-10-31
Recalling firm: Medtronic, Inc.
Product: Alligator Retrieval Device (ARD). Used in the peripheral and neurovasculature for foreign body removal.
Product code: DQY Catheter, Percutaneous
Reason for recall: Potential for the PTFE (polytetrafluoroethylene) coating to delaminate and detach from the delivery wire.
FDA root cause: Process change control
Action: A customer notification letter was sent on 4/1/14 to all customers who purchased the Pipeline Embolization Device and the Alligator Retrieval Device. The letter informs the customers of the problems identified and the actions to be taken. Customers are instructed to complete the customer response form and fax the completed form to Covidien at (763) 591-3519. Customers with questions are instructed to contact Dr. Mark A. Turco at (202) 310-5120. A press release was sent on 4/11/14 to Business Wire Newsroom to inform the public about the recall from Covidien. The recall is regarding certain lots of its Pipeline Embolization Device and Alligator Retrieval Device where the polytetrafluoroethylene (PTFE) coating applied to the delivery wire could delaminate adn detach from the devices. Consumers are instructed to report any adverse reactions or quality problems experienced with the use of the product to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax. Consumers with may also contact Covidien Customer Service at (800) 716-6700 between 7am to 7pm (central) or email at [email protected].
Quantity in commerce: 567 units total (323 units in US)
Distribution: Worldwide Distribution-USA (nationwide) including Puerto Rico and the countries of Australia, Germany, France, UK, Turkey, Argentina, Canada, Colombia, Mexico, , Austria, Belgium, Denmark, Hungary, Italy, Netherlands, Norway, Poland, Portugal, Russia, Slovakia, Slovenia, Spain, Switzerland, and UAE.
Product codes and lots: ARD Model/ Lot FA8881040 / 9769118 FA8881030 / 9816048 FA8881040 / 9754682 FA8881050 / 9772283 FA8881040 / 9752800 FA8881030 / 9751662 FA8881030 / 9773525 FA8881020 / 9832735 FA8881040 / 9757667 FA8881020 / 9774620 FA8881030 / 9834039 FA8881040 / 9758530 FA8881020 / 9774620 FA8881030 / 9834039 FA8881030 / 9758532 FA8881030 / 9783730 FA8881020 / 9836553 FA8881050 / 9760946 FA8881040 / 9786013 FA8881030 / 9834039 FA8881030 / 9761690 FA8881040 / 9787928 FA8881050 / 9848544 FA8881020 / 9761692 FA8881030 / 9791385 FA8881030 / 9848543 FA8881030 / 9758532 FA8881040 / 9793305 FA8881030 / 9853152 FA8881040 / 9764206 FA8881030 / 9798648 FA8881030 / 9854769 FA8881040 / 9764206 FA8881030 / 9798648 FA8881030 / 9858153 FA8881040 / 9764212 FA8881050 / 9801041 FA8881030 / 9865759 FA8881030 / 9766949 FA8881020 / 9811215 FA8881050 / 9868025 FA8881030 / 9769117 FA8881030 / 9813908

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1454-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1453-2014	Class I	Terminated	Voluntary: Firm initiated	2014-04-23	2014-04-16
Z-1454-2014	Class I	Terminated	Voluntary: Firm initiated	2014-04-23	2014-04-16

Product code DQY

K043580Class IIAlligator Retrieval Device (Ard)Chestnut Medical Technologies, Inc. / cleared 2005-03-24

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