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FDA device recall Z-0892-2017 · posted 2016-12-22 · Terminated

Recall details

Recalling firm

Medtronic Inc

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.

Action taken

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.

Root cause

Process control

Status

Terminated

Product code

LIT

Quantity affected

315

Distribution

NY, NC, WA

Date initiated

2016-11-10

Date posted

2016-12-22

Date terminated

2017-08-02

Location

Minneapolis, MN

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