Z-1068-2012

AngioDynamics SPECIAL ORDER Morpheus Smart PICC CT --- 5F Dual Lumen 65cm --- Max CT Flow Rate: 4mL/sec...

Name: Z-1068-2012 AngioDynamics SPECIAL ORDER Morpheus Smart PICC CT --- 5F Dual Lumen 65cm --- Max CT Flow Rate: 4mL/sec...
Creator: Angiodynamics Worldwide Headquarters
Published: 2012-02-06
License: https://open.fda.gov/license/

Angiodynamics Worldwide Headquarters / initiated 2012-02-06 / Terminated / root cause: labeling and UDI

FDA source

Angiodynamics Worldwide Headquarters began a recall of AngioDynamics SPECIAL ORDER Morpheus Smart PICC CT --- 5F Dual Lumen 65cm --- Max CT Flow Rate: 4mL/sec --- Kit Contains: --- 1 each Nitinol Guidewire, 0.46mm... on 2012-02-06. The reason FDA records is "The Morpheus Smart PICC label states the kit contains a Nitinol guidewire; however the kit contains a Platinum guidewire". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1068-2012
Status: Terminated
Initiated: 2012-02-06
Posted: 2012-02-21
Terminated: 2016-02-10
Recalling firm: Angiodynamics Worldwide Headquarters
Product: AngioDynamics SPECIAL ORDER Morpheus Smart PICC CT --- 5F Dual Lumen 65cm --- Max CT Flow Rate: 4mL/sec --- Kit Contains: --- 1 each Nitinol Guidewire, 0.46mm (0.018in.) x 130cm --- Catalog No. [REF] 52110901 --- [Mfg symbol] AngioDynamics, Inc., 603 Queensbury, NY USA 12804. Indicated for short or long term peripheral access to the central venous system for intravenous therapy and power injections of contrast media.
Product code: LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Reason for recall: The Morpheus Smart PICC label states the kit contains a Nitinol guidewire; however the kit contains a Platinum guidewire.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: AngioDynamics sent an "URGENT-MEDICAL DEVICE RECALL" letter dated February 2, 2012 to the single customer. The letter describes the product, problem, and actions to be taken by the customers. The letter instructs the customer to identify and segregate the affected product. A Morpheus Smart PICC Recall Reply Form was enclosed for the customer to complete and return via fax to 518-798-1360. Contact AngioDynamics Customer Service at 1-800-772-6446 for questions regarding this notice.
Quantity in commerce: 25 units
Distribution: Distributed to one customer in Wisconsin.
Product codes and lots: Lot 549559

Product code LJS

K093406Class IIMorpheus Smart Picc CT and Procedure Kit Model 12105509, 12105519AngioDynamics, Inc. / cleared 2010-03-25

Process control is the most common named cause of a device recall11 SEP 2026 / by Medical Device Manufacturing

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)