Z-1552-2016Class II

ev3, PowerCross" 0.018" OTW PTA Dilatation Catheter, model: AB18W030200150, Sterile EO, Rx Only

Name: Z-1552-2016 ev3, PowerCross" 0.018" OTW PTA Dilatation Catheter, model: AB18W030200150, Sterile EO, Rx Only
Creator: ev3, Inc.
Published: 2016-03-29
License: https://open.fda.gov/license/

ev3, Inc. / initiated 2016-03-29 / Terminated / root cause: labeling and UDI

FDA source

ev3, Inc. began a recall of ev3, PowerCross" 0.018" OTW PTA Dilatation Catheter, model: AB18W030200150, Sterile EO, Rx Only on 2016-03-29. FDA classified it as Class II and gives the reason as "Medtronic is conducting a voluntary Urgent Medical Device Recall of two lots of the PowerCross 0.018" Over the Wire (OTW) Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter because the product is mislabeled". 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-1552-2016
Classification: Class II
Status: Terminated
Initiated: 2016-03-29
Posted: 2016-04-22
Terminated: 2017-05-19
Recalling firm: ev3, Inc.
Product: ev3, PowerCross" 0.018" OTW PTA Dilatation Catheter, model: AB18W030200150, Sterile EO, Rx Only.
Product code: LIT Catheter, Angioplasty, Peripheral, Transluminal
Reason for recall: Medtronic is conducting a voluntary Urgent Medical Device Recall of two lots of the PowerCross 0.018" Over the Wire (OTW) Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter because the product is mislabeled.
Root cause tag: labeling and UDI
FDA root cause: Labeling False and Misleading
Action: Consignees were sent on 3/29/2016 a Medtronic "Urgent Medical Device Recall" letter dated March 2016. The letter was addressed to Risk Manger or Health Care Professional. The letter described the problem and the product involved in the recall.
Quantity in commerce: 27 (25 US, 2 OUS)
Distribution: US: CA, GA, LA, MI, MS, MO,NV,NH. NY, OH, PA, SD, TX. OUS: SINGAPORE
Product codes and lots: A213373 and A216702

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1552-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1552-2016	Class II	Terminated	Voluntary: Firm initiated	2016-05-04	2016-04-22

Product code LIT

K093286Class IIPowercross .018 Otw Pta Dilation CatheterEv3, Inc. / cleared 2009-11-13

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)