Z-0892-2017Class II

ev3, PowerCross .018 OTW PTA Dilatation Catheter, Sterile EO. The PowerCross .018 OTW PTA Dilatation Catheter...

Name: Z-0892-2017 ev3, PowerCross .018 OTW PTA Dilatation Catheter, Sterile EO. The PowerCross .018 OTW PTA Dilatation Catheter...
Creator: Medtronic Inc
Published: 2016-11-10
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2016-11-10 / Terminated / root cause: manufacturing process

FDA source

Medtronic Inc began a recall of ev3, PowerCross .018 OTW PTA Dilatation Catheter, Sterile EO. The PowerCross .018 OTW PTA Dilatation Catheter is intended to dilate stenoses in the iliac... on 2016-11-10. FDA classified it as Class II and gives the reason as "Medtronic identified an issue with specific models and lots of the PowerCross .018 Over the Wire (OTW) Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter. During an unrelated manufacturing inspection of...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0892-2017
Classification: Class II
Status: Terminated
Initiated: 2016-11-10
Posted: 2016-12-22
Terminated: 2017-08-02
Recalling firm: Medtronic, Inc.
Product: ev3, PowerCross .018 OTW PTA Dilatation Catheter, Sterile EO. The PowerCross .018 OTW PTA Dilatation Catheter is intended to dilate stenoses in the iliac, femoral, ilio-femoral, popliteal, infrapopliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent post-dilatation in the peripheral vasculature.
Product code: LIT Catheter, Angioplasty, Peripheral, Transluminal
Reason for recall: Medtronic identified an issue with specific models and lots of the PowerCross .018 Over the Wire (OTW) Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter. During an unrelated manufacturing inspection of scrapped products, an out of specification condition was observed. The catheter outer shafts were pinched and deformed at the proximal balloon bond. Bench testing of affected devices showed that this resulted in either the inability to inflate the device, a slow deflation, or the inability to deflate the device post expansion.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Medtronic verbally communicated about the issue on November 20. 2016, to affected customers. Additionally, consignees were hand delivered by Field Sales Representatives a Medtronic "Urgent Medical Device Recall" letter dated November 2016. The letter was addressed to Risk Manger or Health Care Professional. The letter described the problem and the product involved in the recall. Advised consignees to immediately identify, quarantine the affected product, and return it to Medtronic. Requested consignees to complete and email the Customer Confirmation Certificate to [email protected] or fax it to Medtronic at 651-367-0612, attention: Customer Focused Quality. For questions, contact your Medtronic representative. If you require assistance in contacting your representative, please contact Medtronics National Answering Service at 800-633-8766.
Quantity in commerce: 315
Distribution: NY, NC, WA
Product codes and lots: UDI/Product Lot/Serial Product Number UPN/GTIN Number 00821684046647 A358626 AB18W030100150 00821684046883 A357386 AB18W060100150 00821684046722 A357070 AB18W040100150 00821684046777 A358043 AB18W050040150 00821684046722 A356360 AB18W040100150 00821684046777 A357348 AB18W050040150 00821684046562 A359219 AB18W025040150

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0892-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0892-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-28	2016-12-22

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