FDA Medical Device Recalls (openFDA)
Medtronic Inc: 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.
- Recall number
- Z-0892-2017
- 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.
- Status
- Terminated
- Initiated
- 2016-11-10
- Posted
- 2016-12-22
- Terminated
- 2017-08-02
- Reason
- 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
- 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 RS.CFQFCA@medtronic.com 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
- 315
- Distribution
- NY, NC, WA
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K093286"]
- PMA numbers
- not on file
- Product code
- LIT
- Firm FEI
- 3001504994
- Firm city
- Minneapolis
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28